Trial Outcomes & Findings for DIabetic Retinopathy Candesartan Trials. (NCT NCT00252720)

NCT ID: NCT00252720

Last Updated: 2014-06-03

Results Overview

Retinopathy progression was defined as the first occurrence of at least a 3-step increase in the ETDRS severity scale. 3 steps were defined as either a 1-step change in one eye and a 2-step change in the other eye or as a 3-step change in one eye only. EDRTS is a scale with 11 steps (1-11). A generlized log-rank test was used to test difference between treatments.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 1850 participants
• Primary outcome timeframe: From baseline to end of study, i.e. 5 years, with visits after a half year, one year and thereafter one visit per year.
• Results posted on: 2014-06-03

Participant Flow

First subject enrolled in the DIRECT programme 8 June 2001 and last subject completed the DIRECT programme 16 April 2008 mainly in hospital based clinics. The study investigators enrolled 4514 patients with type 1 diabetes to either Study 45 or 46, of whom 1905 proceeded to randomization into Study 46 (1421 into Study 45).

The most common reason for not being randomized was that all eligibility criteria were not fulfilled, followed by withdrawn informed consent.

Participant milestones

Measure	Candesartan Candesartan cilexetil 32 mg once daily	Placebo Placebo Comparator
Overall Study STARTED	951	954
Overall Study COMPLETED	819	789
Overall Study NOT COMPLETED	132	165

Reasons for withdrawal

Measure	Candesartan Candesartan cilexetil 32 mg once daily	Placebo Placebo Comparator
Overall Study Withdrawal by Subject	95	97
Overall Study Death	7	8
Overall Study Moving	23	42
Overall Study Mainly patients lost to follow-up	7	18

Baseline Characteristics

DIabetic Retinopathy Candesartan Trials.

Baseline characteristics by cohort

Measure	Candesartan n=951 Participants Candesartan cilexetil 32 mg once daily	Placebo n=954 Participants Placebo Comparator	Total n=1905 Participants Total of all reporting groups
Region of Enrollment Russian Federation	186 participants n=5 Participants	162 participants n=7 Participants	348 participants n=5 Participants
Region of Enrollment Europe	595 participants n=5 Participants	619 participants n=7 Participants	1214 participants n=5 Participants
Region of Enrollment Canada	69 participants n=5 Participants	71 participants n=7 Participants	140 participants n=5 Participants
Region of Enrollment South Africa	101 participants n=5 Participants	102 participants n=7 Participants	203 participants 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	951 Participants n=5 Participants	954 Participants n=7 Participants	1905 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	31.5 years STANDARD_DEVIATION 8.5 • n=5 Participants	31.9 years STANDARD_DEVIATION 8.5 • n=7 Participants	31.7 years STANDARD_DEVIATION 8.5 • n=5 Participants
Sex: Female, Male Female	413 Participants n=5 Participants	401 Participants n=7 Participants	814 Participants n=5 Participants
Sex: Female, Male Male	538 Participants n=5 Participants	553 Participants n=7 Participants	1091 Participants n=5 Participants

PRIMARY outcome

Timeframe: From baseline to end of study, i.e. 5 years, with visits after a half year, one year and thereafter one visit per year.

Population: The population was the Intention to Treat population which includes all randomized patients with any post-randomization data.

Retinopathy progression was defined as the first occurrence of at least a 3-step increase in the ETDRS severity scale. 3 steps were defined as either a 1-step change in one eye and a 2-step change in the other eye or as a 3-step change in one eye only. EDRTS is a scale with 11 steps (1-11). A generlized log-rank test was used to test difference between treatments.

Outcome measures

Measure	Candesartan n=951 Participants Candesartan cilexetil 32 mg once daily	Placebo n=954 Participants Placebo Comparator
Number of Participants With a 3-step or Greater Increase in Early Treatment of Diabetic Retinopathy Study (EDTRS) Severity Scale	127 Participants 0.034	124 Participants 0.033

SECONDARY outcome

Timeframe: From baseline to the end of the study, i.e., 5 years

Population: The population was the Intention To Treat population which includes all randomized patients with any post-randomization data.

Regression of diabetic retinopathy was defined as at least a 3 step improvement or a persistent 2-step improvement (confirmed in 2 consecutive photography sets) in the Early Treatment of Diabetic Retinopathy Study (ETDRS) severity scale. 3 steps were defined as either a 1-step change in one eye and a 2-step change in the other eye or as a 3-step change in one eye only. EDRTS is a scale with 11 steps (1-11).

Outcome measures

Measure	Candesartan n=951 Participants Candesartan cilexetil 32 mg once daily	Placebo n=954 Participants Placebo Comparator
Number of Participants With a Regression of Diabetic Retinopathy.	140 Participants 0.039	139 Participants 0.039

SECONDARY outcome

Timeframe: From baseline to end of study, i.e. 5 years.

Population: The population was the Intention To Treat population whick includes all randomized patients with any post-randomization data.

Clinically Significant Macular Edema (CSME) and Proliferative Diabetic Retinopathy (PDR) are diagnosed via retinal photographs.

Outcome measures

Measure	Candesartan n=951 Participants Candesartan cilexetil 32 mg once daily	Placebo n=954 Participants Placebo Comparator
Number of Participants With Incident Clinically Significant Macular Edema (CSME) and/or Proliferative Diabetic Retinopathy (PDR).	110 Participants 0.03	107 Participants 0.03

SECONDARY outcome

Timeframe: From baseline to end of study, i.e. 5 years.

Population: The population was the Intention To Treat population which includes all randimized patients with any post-randomization data.

An estimate of the slope from fitting a linear regression of log (UAER) over time (post-randimisation, yearly assessments) for each patient

Outcome measures

Measure	Candesartan n=951 Participants Candesartan cilexetil 32 mg once daily	Placebo n=954 Participants Placebo Comparator
Rate of Change in Urinary Albumin Excretion Rate (UAER).	0.569 log (µg/min)/year Interval 0.489 to 0.648	0.642 log (µg/min)/year Interval 0.563 to 0.722

Adverse Events

Candesartan

Serious events: 173 serious events

Other events: 92 other events

Deaths: 0 deaths

Placebo

Serious events: 161 serious events

Other events: 32 other events

Deaths: 0 deaths

Serious adverse events

Measure	Candesartan n=951 participants at risk Candesartan cilexetil 32 mg once daily	Placebo n=951 participants at risk Placebo Comparator
Blood and lymphatic system disorders Idiopathic Thrombocytopenic Purpura	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Blood and lymphatic system disorders Iron Deficiency Anaemia	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Blood and lymphatic system disorders Thrombocytopenic Purpura	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Cardiac disorders Myocardial Infarction	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.21% 2/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Cardiac disorders Acute Myocardial Infarction	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Cardiac disorders Angina Pectoris	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Cardiac disorders Cardiovascular Disorder	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Congenital, familial and genetic disorders Heart Disease Congenital	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Congenital, familial and genetic disorders Hepato-Lenticular Degeneration	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Ear and labyrinth disorders Ear Congestion	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Ear and labyrinth disorders Sudden Hearing Loss	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Ear and labyrinth disorders Vestibular Neuronitis	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Endocrine disorders Addison's Disease	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Eye disorders Cataract	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Eye disorders Conjunctivitis	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Eye disorders Diabetic Blindness	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Eye disorders Eye Haemorrhage	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Gastrointestinal disorders Gastritis	0.53% 5/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.21% 2/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Gastrointestinal disorders Abdominal Pain	0.21% 2/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Gastrointestinal disorders Inguinal Hernia	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.21% 2/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Gastrointestinal disorders Abdominal Adhesions	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Gastrointestinal disorders Abdominal Pain Lower	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Gastrointestinal disorders Anal Fissure	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Gastrointestinal disorders Change Of Bowel Habit	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Gastrointestinal disorders Coeliac Disease	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Gastrointestinal disorders Diarrhoea	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Gastrointestinal disorders Duodenal Ulcer Perforation	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Gastrointestinal disorders Dyspepsia	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Gastrointestinal disorders Food Poisoning	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Gastrointestinal disorders Gastric Ulcer	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Gastrointestinal disorders Gastrointestinal Haemorrhage	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Gastrointestinal disorders Gingival Disorder	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Gastrointestinal disorders Hiatus Hernia	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Gastrointestinal disorders Irritable Bowel Syndrome	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Gastrointestinal disorders Pancreatitis Acute	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Gastrointestinal disorders Rectal Polyp	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Gastrointestinal disorders Vomiting	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
General disorders Chest Pain	0.53% 5/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
General disorders Death	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
General disorders Foreign Body Reaction	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
General disorders Macrosomia	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
General disorders Oedema	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
General disorders Oedema Peripheral	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
General disorders Organ Failure	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
General disorders Pyrexia	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Hepatobiliary disorders Cholelithiasis	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Hepatobiliary disorders Hepatitis Acute	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Hepatobiliary disorders Hepatitis Toxic	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Immune system disorders Sarcoidosis	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Infections and infestations Appendicitis	0.42% 4/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.42% 4/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Infections and infestations Gastroenteritis	0.21% 2/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.32% 3/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Infections and infestations Pneumonia	0.32% 3/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.32% 3/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Infections and infestations Pyelonephritis Acute	0.32% 3/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Infections and infestations Respiratory Tract Infection	0.32% 3/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Infections and infestations Bronchitis	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.21% 2/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Infections and infestations Hepatitis B	0.21% 2/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Infections and infestations Localised Infection	0.21% 2/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Infections and infestations Pilonidal Cyst	0.21% 2/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Infections and infestations Postoperative Wound Infection	0.21% 2/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Infections and infestations Pyelonephritis	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.21% 2/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Infections and infestations Sepsis	0.21% 2/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Infections and infestations Upper Respiratory Tract Infection	0.21% 2/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Infections and infestations Viral Infection	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.21% 2/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Infections and infestations Abdominal Abscess	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Infections and infestations Abdominal Wall Abscess	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Infections and infestations Abscess	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Infections and infestations Abscess Limb	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Infections and infestations Acute Tonsillitis	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Infections and infestations Adnexitis	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Infections and infestations Bronchopneumonia	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Infections and infestations Carbuncle	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Infections and infestations Cellulitis	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Infections and infestations Corneal Infection	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Infections and infestations Empyema	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Infections and infestations Encephalitis Viral	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Infections and infestations Gastrointestinal Infection	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Infections and infestations Groin Abscess	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Infections and infestations Hepatitis A	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Infections and infestations Hepatitis C	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Infections and infestations Herpes Zoster	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Infections and infestations Infected Cyst	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Infections and infestations Liver Abscess	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Infections and infestations Lower Respiratory Tract Infection	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Infections and infestations Oophoritis	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Infections and infestations Osteomyelitis	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Infections and infestations Pelvic Inflammatory Disease	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Infections and infestations Perianal Abscess	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Infections and infestations Perineal Abscess	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Infections and infestations Peritonsillar Abscess	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Infections and infestations Pulmonary Tuberculosis	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Infections and infestations Pyelonephritis Chronic	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Infections and infestations Retroperitoneal Abscess	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Infections and infestations Subcutaneous Abscess	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Infections and infestations Viral Diarrhoea	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Infections and infestations Viral Skin Infection	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Infections and infestations Wound Infection Staphylococcal	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Injury, poisoning and procedural complications Road Traffic Accident	0.42% 4/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.21% 2/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Injury, poisoning and procedural complications Meniscus Lesion	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.32% 3/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Injury, poisoning and procedural complications Multiple Injuries	0.21% 2/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.32% 3/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Injury, poisoning and procedural complications Hand Fracture	0.21% 2/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Injury, poisoning and procedural complications Humerus Fracture	0.21% 2/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Injury, poisoning and procedural complications Ligament Injury	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.21% 2/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Injury, poisoning and procedural complications Lower Limb Fracture	0.21% 2/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.21% 2/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Injury, poisoning and procedural complications Overdose	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.21% 2/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Injury, poisoning and procedural complications Accidental Overdose	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Nervous system disorders Grand Mal Convulsion	0.21% 2/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Injury, poisoning and procedural complications Ankle Fracture	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Injury, poisoning and procedural complications Cartilage Injury	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Injury, poisoning and procedural complications Cervical Vertebral Fracture	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Injury, poisoning and procedural complications Concussion	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Injury, poisoning and procedural complications Contusion	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Injury, poisoning and procedural complications Epicondylitis	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Injury, poisoning and procedural complications Femur Fracture	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Injury, poisoning and procedural complications Foot Fracture	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Injury, poisoning and procedural complications Frostbite	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Injury, poisoning and procedural complications Gun Shot Wound	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Injury, poisoning and procedural complications Hip Fracture	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Injury, poisoning and procedural complications Injury Corneal	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Injury, poisoning and procedural complications Intentional Overdose	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Injury, poisoning and procedural complications Intervertebral Disc Injury	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Injury, poisoning and procedural complications Joint Dislocation	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Injury, poisoning and procedural complications Joint Injury	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Injury, poisoning and procedural complications Ligament Rupture	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Injury, poisoning and procedural complications Limb Injury	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Injury, poisoning and procedural complications Multiple Fractures	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Injury, poisoning and procedural complications Patella Fracture	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Nervous system disorders Amnesia	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Injury, poisoning and procedural complications Radius Fracture	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Injury, poisoning and procedural complications Skin Laceration	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Injury, poisoning and procedural complications Skull Fractured Base	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Injury, poisoning and procedural complications Sports Injury	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Injury, poisoning and procedural complications Tendon Injury	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Injury, poisoning and procedural complications Thermal Burn	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Injury, poisoning and procedural complications Tibia Fracture	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Investigations Hepatitis C Positive	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Investigations Tumour Marker Increased	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Metabolism and nutrition disorders Diabetic Ketoacidosis	2.7% 26/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	1.8% 17/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Metabolism and nutrition disorders Hypoglycaemia	1.7% 16/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	2.5% 24/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Metabolism and nutrition disorders Hyperglycaemia	0.84% 8/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	1.4% 13/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Metabolism and nutrition disorders Diabetes Mellitus Inadequate Control	1.2% 11/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.84% 8/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Metabolism and nutrition disorders Ketoacidosis	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.63% 6/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Metabolism and nutrition disorders Hypoglycaemic Seizure	0.42% 4/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Metabolism and nutrition disorders Dehydration	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Metabolism and nutrition disorders Diabetic Foot	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Musculoskeletal and connective tissue disorders Periarthritis	0.42% 4/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Musculoskeletal and connective tissue disorders Intervertebral Disc Protrusion	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.32% 3/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Musculoskeletal and connective tissue disorders Musculoskeletal Chest Pain	0.21% 2/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.21% 2/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Musculoskeletal and connective tissue disorders Arthralgia	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Musculoskeletal and connective tissue disorders Dupuytren's Contracture	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Musculoskeletal and connective tissue disorders Myopathy	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Musculoskeletal and connective tissue disorders Osteoarthropathy	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Musculoskeletal and connective tissue disorders Rotator Cuff Syndrome	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Musculoskeletal and connective tissue disorders Spondylolisthesis	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Musculoskeletal and connective tissue disorders Tenosynovitis	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Musculoskeletal and connective tissue disorders Trigger Finger	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Fibroadenoma Of Breast	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.21% 2/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant Melanoma	0.21% 2/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Anaplastic Astrocytoma	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign Colonic Neoplasm	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Fibroma	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic Adenoma	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphoma	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian Adenoma	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Papillary Thyroid Cancer	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Penile Wart	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine Leiomyoma	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Nervous system disorders Hypoglycaemic Coma	0.32% 3/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.53% 5/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Nervous system disorders Carpal Tunnel Syndrome	0.42% 4/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Nervous system disorders Diabetic Coma	0.21% 2/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Nervous system disorders Diabetic Neuropathy	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.21% 2/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Nervous system disorders Cerebral Haemorrhage	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Nervous system disorders Cerebrovascular Accident	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Nervous system disorders Diabetic Hyperosmolar Coma	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Nervous system disorders Diabetic Ketoacidotic Hyperglycaemic Coma	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Nervous system disorders Dizziness	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Nervous system disorders Encephalopathy	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Nervous system disorders Haemorrhagic Stroke	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Nervous system disorders Headache	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Nervous system disorders Migraine	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Nervous system disorders Multiple Sclerosis	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Nervous system disorders Myelitis	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Nervous system disorders Sciatica	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Nervous system disorders Syncope	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Nervous system disorders Tension Headache	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Pregnancy, puerperium and perinatal conditions Abortion Spontaneous	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Pregnancy, puerperium and perinatal conditions Foetal Cardiac Disorder	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Pregnancy, puerperium and perinatal conditions Intra-Uterine Death	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Pregnancy, puerperium and perinatal conditions Polyhydramnios	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Psychiatric disorders Depression	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Psychiatric disorders Major Depression	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Psychiatric disorders Suicide Attempt	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Renal and urinary disorders Nephrolithiasis	0.21% 2/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Renal and urinary disorders Calculus Urinary	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Renal and urinary disorders Diabetic Nephropathy	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Renal and urinary disorders Haematuria	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Renal and urinary disorders Renal Failure	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Renal and urinary disorders Ureteric Stenosis	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Reproductive system and breast disorders Adenomyosis	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.21% 2/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Reproductive system and breast disorders Cervical Dysplasia	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Reproductive system and breast disorders Dysfunctional Uterine Bleeding	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Reproductive system and breast disorders Endometriosis	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Reproductive system and breast disorders Menometrorrhagia	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Reproductive system and breast disorders Menorrhagia	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Reproductive system and breast disorders Ovarian Cyst	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Reproductive system and breast disorders Pelvic Pain	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Reproductive system and breast disorders Uterine Polyp	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Reproductive system and breast disorders Varicocele	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Respiratory, thoracic and mediastinal disorders Bronchitis Chronic	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Respiratory, thoracic and mediastinal disorders Chronic Obstructive Pulmonary Disease	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Respiratory, thoracic and mediastinal disorders Nasal Congestion	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Respiratory, thoracic and mediastinal disorders Nasal Polyps	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Respiratory, thoracic and mediastinal disorders Nasal Septum Deviation	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Respiratory, thoracic and mediastinal disorders Pneumomediastinum	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Respiratory, thoracic and mediastinal disorders Tonsillar Hypertrophy	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Respiratory, thoracic and mediastinal disorders Vocal Cord Polyp	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Skin and subcutaneous tissue disorders Angioedema	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Skin and subcutaneous tissue disorders Dermal Cyst	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Skin and subcutaneous tissue disorders Erythema Nodosum	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Skin and subcutaneous tissue disorders Skin Ulcer	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Vascular disorders Hypotension	0.21% 2/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Vascular disorders Femoral Artery Occlusion	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Vascular disorders Hypertension	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Vascular disorders Thrombosis	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Vascular disorders Varicose Vein	0.00% 0/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	0.11% 1/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.

Other adverse events

Measure	Candesartan n=951 participants at risk Candesartan cilexetil 32 mg once daily	Placebo n=951 participants at risk Placebo Comparator
Vascular disorders Hypotension	9.7% 92/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.	3.4% 32/951 • During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment. Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.

Additional Information

Niklas Berglind, GPS Atacand

AstraZeneca

Phone: +46 31 7766310

Email: ClinicalTrialTransparency@astrazeneca.com

Results disclosure agreements

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