Study to Evaluate the Effect of Fluticasone Furoate/Vilanterol on Survival in Subjects With Chronic Obstructive Pulmonary Disease

• Sponsor: GlaxoSmithKline (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01313676
• Collaborator: (none)
• Enrollment: 16,568
• Locations: 1621
• Arms: 4
• Actual Duration (Months): 53.6
• Patients Per Site: 10.2
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

The purpose of this study is to determine if fluticasone furoate/vilanterol improves survival in patients with chronic obstructive pulmonary disease with a history of or increased risk of heart disease.

Condition or Disease	Intervention/Treatment	Phase
Pulmonary Disease, Chronic Obstructive	Drug: fluticasone furoate/vilanterol; Drug: fluticasone furoate; Drug: vilanterol; Other: Placebo	Phase 3

Detailed Description

Despite a potential link between the pathogenetic mechanisms involved in Chronic Obstructive Pulmonary Disease (COPD) and atherosclerotic cardiovascular disease, there are no currently approved therapies for patients with COPD that have clearly shown an additional beneficial effect in patients with cardiovascular comorbidities. The TOwards a Revolution in COPD Health (TORCH) study assessed the impact of the inhaled corticosteroid (ICS) fluticasone propionate (FP) in combination with the long-acting beta agonist (LABA), salmeterol (SAL), in reducing all-cause mortality. TORCH demonstrated a 17.5% reduction on all-cause mortality with salmeterol-fluticasone propionate combination (SFC) compared with placebo (HR=0.825, 95% CI (0.681, 1.002), p=0.052) in the entire COPD population with disease severity form moderate to very severe. A post hoc analysis of the data restricted to those subjects with an forced expiratory volume in 1 second (FEV1) >=50% predicted with an apparent history of cardiovascular co-morbidities (defined as use at baseline of beta-blockers, angiotensin converting enzyme inhibitors (ACEI)/angiotensin receptor blockers (ARB), HMG CoA reductase inhibitors (i.e. statins) or a prior MI recorded at baseline) demonstrated a 49% reduction in the risk of dying within 96 weeks for the comparison of SFC with placebo. These post hoc data suggest the possibility of an ICS/LABA combination product to be of substantial benefit in COPD subjects with less severe airflow obstruction yet with increased cardiovascular risk.

The mechanism by which SFC appears to be associated with a greater reduction in mortality in these less severe COPD subjects with concomitant cardiovascular comorbidities is speculative at present, but could potentially in part be related to a lessening of the degree of inflammation in the systemic circulation, potential plaque stabilization and/or amelioration of arterial stiffness.

ICS/LABA combinations that are currently available require twice daily administration. A once daily ICS/LABA combination has the potential to improve patient compliance and as a result, overall disease management.

The purpose of this study is to prospectively evaluate the effect of the once daily ICS/LABA combination Fluticasone Furoate (FF)/Vilanterol (VI) on survival in subjects with moderate COPD (>=50 and =<70 % predicted FEV1 ) and a history of, or at increased risk for cardiovascular disease.

Study Design

• Study Type: Interventional
• Actual Enrollment: 16568 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Clinical Outcomes Study to Compare the Effect of Fluticasone Furoate/Vilanterol Inhalation Powder 100/25mcg With Placebo on Survival in Subjects With Moderate Chronic Obstructive Pulmonary Disease (COPD) and a History of or at Increased Risk for Cardiovascular Disease
• Actual Study Start Date: Jan 25, 2011
• Actual Primary Completion Date: Jul 15, 2015
• Actual Study Completion Date: Jul 15, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: fluticasone furoate/vilanterol Combination of both products in one inhaler	Drug: fluticasone furoate/vilanterol; 100/25mcg given once daily via novel dry powder inhaler
Experimental: fluticasone furoate comparator of individual component	Drug: fluticasone furoate; 100mcg given once daily via novel dry powder inhaler
Experimental: vilanterol comparator of individual component	Drug: vilanterol; 25mcg given once daily via novel dry powder inhaler
Placebo Comparator: placebo once daily via inhaler	Other: Placebo; placebo comparator once daily via novel dry powder inhaler

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Death (Both on and Off Treatment) Due to Any Cause, Time up to or on the Pre-determined Common End Date [From the date of randomization until date of death due to any cause (average of 2 study years)]

   Death from any cause: which occurred from the day of starting IP until the Commone End Date (CED). Common End Date (CED) is the study end date that was pre determined where approximately 1000 deaths would have occurred in the Intent-toTreat Efficacy (ITT-E) Population. Only deaths which occurred on or before the CED were used for the primary analysis. Those who had not died by CED, but who were known to be alive on or after the CED, were censored at the CED. Cox Proportional Hazards (PH) Model was adjusted for age, and gender, including all 4 arms. A hazard ratio of less than 1 indicates a lower death rate versus placebo or other arm. ITT-E Population consisted of all participants in the Safety Population (i.e. randomized to IP and who received at least one dose of IP), with the exception of those recruited at sites that were closed.

Secondary Outcome Measures

1. Decline in Forced Expiratory Volume in 1 Second (FEV1) [From start date of IP until IP stop date + 1 (assessed up to 4 years)]

   FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. The effect of treatment on decline of post bronchodilator FEV1 recorded during the treatment period was analyzed using a particular form of a mixed effect model - a random coefficients model. FEV1 was fitted as the response variable with treatment group, age, gender, baseline FEV1 and time on treatment as fixed effects. Time on treatment was treated as a continuous variable. This model allowed for an initial increase in FEV1, but then tested the difference in slopes from the first post-baseline measurement which was at 3 months. A negative slope indicates a decline. A positive treatment difference indicates a slower rate of decline vs Placebo or Component. Only participants with at least one on-treatment post-bronchodilator FEV1 measurement were analyzed.

2. Number of Participants With First On-treatment Cardiovascular (CV) Composite Events Occured on or Before Common End Date [From the start of IP to first on treatment CV event till 7 days after the last dose of IP (average of 2 study years)]

   On-treatment CV composite event is comprised of the first event that is adjudicated as on-treatment CV death, myocardial infarction, stroke, unstable angina, or transient ischemic attack experienced by a participant. The events that occurred no more than 7 days after the participants last dose of IP are considered as on-treatment adverse events. Common end date is the study end date where approximately 1000 deaths would have occurred in the ITT-E Population. Cox PH Model was used to assess time to first on-treatment CV composite event. Cox PH Model was adjusted for age, gender and indicators of ischemic and vascular disease, including all four treatment arms. A hazard ratio less than 1 indicates a lower risk of a first CV event rate versus placebo or any arm.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Type of subject: outpatient.

• Informed consent: Subjects must give their signed and dated written informed consent to participate.

• Gender: Male or female. Female subjects must be post-menopausal or using a highly effective method for avoidance of pregnancy. The decision to include or exclude women of childbearing potential may be made at the discretion of the investigator in accordance with local practice in relation to adequate contraception.

• Age: >=40 and <=80 years of age at Screening (Visit 1).

• Tobacco use: Subjects with a current or prior history of >=10 pack-years of cigarette smoking at screening (Visit 1). Previous smokers are defined as those who have stopped smoking for at least 6 months prior to Visit 1.

• Airflow Obstruction:

Subjects with a measured post-albuterol/salbutamol forced expiratory volume in 1 second (FEV1)/(forced vital capacity)FVC ratio of <=0.70 at Screening (Visit 1).

Subjects with a measured post-albuterol/salbutamol FEV1 >=50 and <=70% of predicted normal values calculated using NHANES III reference equations [Hankinson, 1999; Hankinson, 2010] at Screening (Visit 1).

Post-bronchodilator spirometry will be performed approximately 15 minutes after the subject has self-administered 4 inhalations (i.e., total 400mcg) of albuterol/salbutamol via a metered dose inhaler (MDI )with a valved-holding chamber. The FEV1/FVC ratio and FEV1 percent predicted values will be calculated.

• Symptoms of COPD: Subjects must score 2 or higher on the modified Medical Research Council Dyspnea scale (Visit 1)

• Cardiovascular disease:

For patients >= 40 years of age: any one of the following:

Established (i.e. by clinical signs or imaging studies) coronary artery disease (CAD) Established (i.e. by clinical signs or imaging studies) peripheral vascular disease (PVD) Previous stroke Previous MI Diabetes mellitus with target organ disease OR

For patients >=60 years of age: any 2 of the following:

Being treated for hypercholesterolemia Being treated for hypertension Being treated for diabetes mellitus Being treated for peripheral vascular disease

Exclusion Criteria:

• Pregnancy: Women who are pregnant or lactating.

• Asthma: Subjects with a current diagnosis of asthma. (Subjects with a prior history of asthma are eligible if they also have a current diagnosis of COPD).

• alpha 1-antitrypsin deficiency: Subjects with known alpha-1 antitrypsin deficiency as the underlying cause of COPD.

• Other respiratory disorders: Subjects with active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, pulmonary fibrosis, pulmonary hypertension, interstitial lung diseases or other active pulmonary diseases.

• Lung resection or transplantation: Subjects with lung volume reduction surgery within the 12 months prior to Screening or having had a lung transplant.

• A moderate/severe COPD exacerbation that has not resolved at least 14 days prior to Visit 1 and at least 30 days following the last dose of oral corticosteroids (if applicable).

• Current severe heart failure (New York Heart Association class IV). Subjects will also be excluded if they have a known ejection fraction of <30% or if they have an implantable cardioverter defibrillator (ICD).

• Other diseases/abnormalities: Any life-threatening condition with life expectancy <3 years, other than vascular disease or COPD, that might prevent the subject from completing the study.

• End stage chronic renal disease: Subjects will be excluded if on renal replacement therapy (hemodialysis or peritoneal).

• Drug/food allergy: Subjects with a history of hypersensitivity to any of the study medications (e.g. beta-agonists, corticosteroid) or components of the inhalation powder (e.g. lactose, magnesium stearate). In addition, patients with a history of severe milk protein allergy that, in the opinion of the study physician, contraindicates the subject's participation will also be excluded.

• Drug/alcohol abuse: Subjects with a known or suspected history of alcohol or drug abuse within the last 2 years.

• Oxygen therapy: Subjects receiving treatment with long-term oxygen therapy (LTOT) or nocturnal oxygen therapy required for greater than 12 hours a day. Oxygen prn use (i.e. <=12 hours per day) is not exclusionary.

• Questionable validity of consent: Subjects with a history of psychiatric disease, intellectual deficiency, poor motivation or other conditions that will limit the validity of informed consent to participate in the study or the potential compliance to study procedures.

• Affiliation with investigator site: Study investigators, sub-investigators, study coordinators, employees of a participating investigator or immediate family members of the aforementioned are excluded from participating in this study.

• Additional medication: Use of the following medications within the following time intervals prior to Visit 1 or during the study (unless otherwise specified):

Medication No use within the following time intervals prior to Screening or thereafter at any time during the study (unless otherwise specified) Inhaled Long acting beta-agonists (LABA) 48 hours ICS/LABA combination products 48 hours Inhaled corticosteroids 48 hours Tiotropium 1 week Systemic, Oral, parenteral, intra-articular corticosteroids 30 days (oral and systemic corticosteroids may be used to treat COPD exacerbations during the study) Cytochrome P450 3A4 strong inhibitors including but not limited to antiretrovirals (protease inhibitors) (e.g.Indinavir, Nelfinavir, Ritonavir, Saquinavir); Imidazole and Triazole anti-fungals (e.g. Ketaconazole, Itraconazole); Clarithromycin, Telithromycin, Amiodarone, and Nefazodone 6 weeks Grapefruit is allowed up to Visit 1, then limited to no more than one glass of grapefruit juice (250 mL/ 8 ounces) or one grapefruit per day Any other investigational drug 30 days or 5 half lives whichever is longer.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Andalusia	Alabama	United States	36420
2	GSK Investigational Site	Athens	Alabama	United States	35611
3	GSK Investigational Site	Birmingham	Alabama	United States	35209
4	GSK Investigational Site	Birmingham	Alabama	United States	35216
5	GSK Investigational Site	Birmingham	Alabama	United States	35233
6	GSK Investigational Site	Birmingham	Alabama	United States	35242
7	GSK Investigational Site	Huntsville	Alabama	United States	35801
8	GSK Investigational Site	Huntsville	Alabama	United States	35816
9	GSK Investigational Site	Mobile	Alabama	United States	36604
10	GSK Investigational Site	Mobile	Alabama	United States	36608
11	GSK Investigational Site	Montgomery	Alabama	United States	36106
12	GSK Investigational Site	Montgomery	Alabama	United States	36109
13	GSK Investigational Site	Muscle Shoals	Alabama	United States	35662
14	GSK Investigational Site	Ozark	Alabama	United States	36360
15	GSK Investigational Site	Pell City	Alabama	United States	35128
16	GSK Investigational Site	Tuscumbia	Alabama	United States	35674
17	GSK Investigational Site	Flagstaff	Arizona	United States	86001
18	GSK Investigational Site	Glendale	Arizona	United States	85306
19	GSK Investigational Site	Phoenix	Arizona	United States	85018
20	GSK Investigational Site	Phoenix	Arizona	United States	85032
21	GSK Investigational Site	Scottsdale	Arizona	United States	85258
22	GSK Investigational Site	Sierra Vista	Arizona	United States	85635
23	GSK Investigational Site	Tucson	Arizona	United States	85710
24	GSK Investigational Site	Tucson	Arizona	United States	85745
25	GSK Investigational Site	Fayetteville	Arkansas	United States	72703
26	GSK Investigational Site	Jonesboro	Arkansas	United States	72401
27	GSK Investigational Site	Anaheim	California	United States	92801
28	GSK Investigational Site	Bakersfield	California	United States	93301
29	GSK Investigational Site	Cerritos	California	United States	90703
30	GSK Investigational Site	Encinitas	California	United States	92024
31	GSK Investigational Site	Foothill Ranch	California	United States	92610
32	GSK Investigational Site	Fountain Valley	California	United States	92708
33	GSK Investigational Site	Garden Grove	California	United States	92844
34	GSK Investigational Site	Gold River	California	United States	95670
35	GSK Investigational Site	Huntington Beach	California	United States	92647
36	GSK Investigational Site	Huntington Park	California	United States	90255
37	GSK Investigational Site	Lakewood	California	United States	90712
38	GSK Investigational Site	Lancaster	California	United States	93534
39	GSK Investigational Site	Loma Linda	California	United States	92357
40	GSK Investigational Site	Long Beach	California	United States	90822
41	GSK Investigational Site	Los Angeles	California	United States	90033
42	GSK Investigational Site	Los Angeles	California	United States	90036
43	GSK Investigational Site	Los Angeles	California	United States	90048
44	GSK Investigational Site	Los Angeles	California	United States	90095
45	GSK Investigational Site	Mission Hills	California	United States	91345
46	GSK Investigational Site	Mission Viejo	California	United States	92691
47	GSK Investigational Site	Modesto	California	United States	95350
48	GSK Investigational Site	Montclair	California	United States	91763
49	GSK Investigational Site	Monterey Park	California	United States	91754
50	GSK Investigational Site	Oxnard	California	United States	93030-5841
51	GSK Investigational Site	Palo Alto	California	United States	94304
52	GSK Investigational Site	Pasadena	California	United States	91105
53	GSK Investigational Site	Pismo Beach	California	United States	93449
54	GSK Investigational Site	Rancho Mirage	California	United States	92270
55	GSK Investigational Site	Riverside	California	United States	92506
56	GSK Investigational Site	Rolling Hills Estates	California	United States	90274
57	GSK Investigational Site	Sacramento	California	United States	95816
58	GSK Investigational Site	Sacramento	California	United States	95817
59	GSK Investigational Site	Sacramento	California	United States	95819
60	GSK Investigational Site	Sacramento	California	United States	95821
61	GSK Investigational Site	San Diego	California	United States	91910
62	GSK Investigational Site	San Diego	California	United States	92103
63	GSK Investigational Site	San Diego	California	United States	92108
64	GSK Investigational Site	San Diego	California	United States	92111
65	GSK Investigational Site	San Diego	California	United States	92117
66	GSK Investigational Site	San Diego	California	United States	92120
67	GSK Investigational Site	San Gabriel	California	United States	91776
68	GSK Investigational Site	San Jose	California	United States	95116
69	GSK Investigational Site	San Marino	California	United States	91108
70	GSK Investigational Site	Santa Monica	California	United States	90404
71	GSK Investigational Site	Sepulveda	California	United States	91343
72	GSK Investigational Site	Simi Valley	California	United States	93065
73	GSK Investigational Site	Stockton	California	United States	95207
74	GSK Investigational Site	Torrance	California	United States	90502
75	GSK Investigational Site	Torrance	California	United States	90505
76	GSK Investigational Site	Van Nuys	California	United States	91405
77	GSK Investigational Site	Ventura	California	United States	93003
78	GSK Investigational Site	West Covina	California	United States	91790
79	GSK Investigational Site	Centennial	Colorado	United States	80112
80	GSK Investigational Site	Colorado Springs	Colorado	United States	80907
81	GSK Investigational Site	Colorado Springs	Colorado	United States	80910
82	GSK Investigational Site	Denver	Colorado	United States	80206
83	GSK Investigational Site	Fort Collins	Colorado	United States	80528
84	GSK Investigational Site	Fort Collins	Colorado	United States	80538
85	GSK Investigational Site	Wheat Ridge	Colorado	United States	80033
86	GSK Investigational Site	Danbury	Connecticut	United States	06810
87	GSK Investigational Site	Hartford	Connecticut	United States	06105
88	GSK Investigational Site	Waterbury	Connecticut	United States	06708
89	GSK Investigational Site	Washington	District of Columbia	United States	20422
90	GSK Investigational Site	Altamonte Springs	Florida	United States	32714
91	GSK Investigational Site	Aventura	Florida	United States	33180
92	GSK Investigational Site	Bay Pines	Florida	United States	33744
93	GSK Investigational Site	Boynton Beach	Florida	United States	33435
94	GSK Investigational Site	Boynton Beach	Florida	United States	33472
95	GSK Investigational Site	Brandon	Florida	United States	33511
96	GSK Investigational Site	Celebration	Florida	United States	34747
97	GSK Investigational Site	Clearwater	Florida	United States	33755
98	GSK Investigational Site	Clearwater	Florida	United States	33756
99	GSK Investigational Site	Clearwater	Florida	United States	33759
100	GSK Investigational Site	Clearwater	Florida	United States	33765-2616
101	GSK Investigational Site	Clearwater	Florida	United States	33765
102	GSK Investigational Site	Crystal River	Florida	United States	34429
103	GSK Investigational Site	Daytona Beach	Florida	United States	32117
104	GSK Investigational Site	DeBary	Florida	United States	32173
105	GSK Investigational Site	DeLand	Florida	United States	32720
106	GSK Investigational Site	Edgewater	Florida	United States	32132
107	GSK Investigational Site	Fleming Island	Florida	United States	32003
108	GSK Investigational Site	Fort Lauderdale	Florida	United States	33316
109	GSK Investigational Site	Gainesville	Florida	United States	32608
110	GSK Investigational Site	Hialeah	Florida	United States	33012
111	GSK Investigational Site	Hialeah	Florida	United States	33013
112	GSK Investigational Site	Hialeah	Florida	United States	33016
113	GSK Investigational Site	Hollywood	Florida	United States	33021
114	GSK Investigational Site	Jacksonville	Florida	United States	32209
115	GSK Investigational Site	Jacksonville	Florida	United States	32216
116	GSK Investigational Site	Kissimmee	Florida	United States	34741
117	GSK Investigational Site	Leesburg	Florida	United States	34748
118	GSK Investigational Site	Lehigh Acres	Florida	United States	33971
119	GSK Investigational Site	Maitland	Florida	United States	32751
120	GSK Investigational Site	Melbourne	Florida	United States	32934
121	GSK Investigational Site	Miami Gardens	Florida	United States	33169
122	GSK Investigational Site	Miami	Florida	United States	33015
123	GSK Investigational Site	Miami	Florida	United States	33125
124	GSK Investigational Site	Miami	Florida	United States	33126
125	GSK Investigational Site	Miami	Florida	United States	33133
126	GSK Investigational Site	Miami	Florida	United States	33135
127	GSK Investigational Site	Miami	Florida	United States	33142
128	GSK Investigational Site	Miami	Florida	United States	33144
129	GSK Investigational Site	Miami	Florida	United States	33155
130	GSK Investigational Site	Miami	Florida	United States	33165
131	GSK Investigational Site	Miami	Florida	United States	33174
132	GSK Investigational Site	Miami	Florida	United States	33175
133	GSK Investigational Site	Miami	Florida	United States	33185
134	GSK Investigational Site	Miami	Florida	United States	33186
135	GSK Investigational Site	New Port Richey	Florida	United States	34652
136	GSK Investigational Site	North Miami Beach	Florida	United States	33179
137	GSK Investigational Site	Oakland Park	Florida	United States	33309
138	GSK Investigational Site	Ocala	Florida	United States	34471
139	GSK Investigational Site	Orlando	Florida	United States	32803
140	GSK Investigational Site	Orlando	Florida	United States	32811
141	GSK Investigational Site	Orlando	Florida	United States	32825
142	GSK Investigational Site	Palm Harbor	Florida	United States	34684
143	GSK Investigational Site	Pembroke Pines	Florida	United States	33027
144	GSK Investigational Site	Pensacola	Florida	United States	32503
145	GSK Investigational Site	Pensacola	Florida	United States	32514
146	GSK Investigational Site	Pinellas Park	Florida	United States	33781
147	GSK Investigational Site	Port Charlotte	Florida	United States	33952
148	GSK Investigational Site	Port Orange	Florida	United States	32129
149	GSK Investigational Site	Saint Petersburg	Florida	United States	33704
150	GSK Investigational Site	Saint Petersburg	Florida	United States	33707
151	GSK Investigational Site	Saint Petersburg	Florida	United States	33709
152	GSK Investigational Site	Saint Petersburg	Florida	United States	33713
153	GSK Investigational Site	Sarasota	Florida	United States	34239
154	GSK Investigational Site	South Miami	Florida	United States	33143
155	GSK Investigational Site	Summerfield	Florida	United States	34491
156	GSK Investigational Site	Tamarac	Florida	United States	33319
157	GSK Investigational Site	Tampa	Florida	United States	33603
158	GSK Investigational Site	Tampa	Florida	United States	33607
159	GSK Investigational Site	Tampa	Florida	United States	33613
160	GSK Investigational Site	Trinity	Florida	United States	34655
161	GSK Investigational Site	Vero Beach	Florida	United States	32958
162	GSK Investigational Site	Vero Beach	Florida	United States	32960
163	GSK Investigational Site	Wellington	Florida	United States	33414
164	GSK Investigational Site	Winter Park	Florida	United States	32789
165	GSK Investigational Site	Zephyrhills	Florida	United States	33540
166	GSK Investigational Site	Atlanta	Georgia	United States	30342
167	GSK Investigational Site	Austell	Georgia	United States	30106
168	GSK Investigational Site	Blue Ridge	Georgia	United States	30513
169	GSK Investigational Site	Calhoun	Georgia	United States	30701
170	GSK Investigational Site	Canton	Georgia	United States	30114
171	GSK Investigational Site	Columbus	Georgia	United States	31904
172	GSK Investigational Site	Cumming	Georgia	United States	30041
173	GSK Investigational Site	Decatur	Georgia	United States	30033
174	GSK Investigational Site	Gainesville	Georgia	United States	30501
175	GSK Investigational Site	Lawrenceville	Georgia	United States	30046
176	GSK Investigational Site	Marietta	Georgia	United States	30060
177	GSK Investigational Site	Rincon	Georgia	United States	31326
178	GSK Investigational Site	Suwanee	Georgia	United States	30024
179	GSK Investigational Site	Woodstock	Georgia	United States	30189
180	GSK Investigational Site	Honolulu	Hawaii	United States	96813
181	GSK Investigational Site	Boise	Idaho	United States	83642
182	GSK Investigational Site	Coeur d'Alene	Idaho	United States	90212
183	GSK Investigational Site	Hayden Lake	Idaho	United States	83835
184	GSK Investigational Site	Idaho Falls	Idaho	United States	83402
185	GSK Investigational Site	Nampa	Idaho	United States	83687
186	GSK Investigational Site	Aurora	Illinois	United States	60504
187	GSK Investigational Site	Champaign	Illinois	United States	61820
188	GSK Investigational Site	Chicago	Illinois	United States	60603
189	GSK Investigational Site	Chicago	Illinois	United States	60612
190	GSK Investigational Site	Evergreen Park	Illinois	United States	60805
191	GSK Investigational Site	Gillespie	Illinois	United States	62033
192	GSK Investigational Site	Melrose Park	Illinois	United States	60160
193	GSK Investigational Site	North Chicago	Illinois	United States	60064
194	GSK Investigational Site	Oak Lawn	Illinois	United States	60453
195	GSK Investigational Site	Peoria	Illinois	United States	61602
196	GSK Investigational Site	Quincy	Illinois	United States	62301
197	GSK Investigational Site	River Forest	Illinois	United States	60305
198	GSK Investigational Site	Skokie	Illinois	United States	60076
199	GSK Investigational Site	Avon	Indiana	United States	46123
200	GSK Investigational Site	Elwood	Indiana	United States	46036
201	GSK Investigational Site	Evansville	Indiana	United States	47714
202	GSK Investigational Site	Franklin	Indiana	United States	46131
203	GSK Investigational Site	Greenfield	Indiana	United States	46140
204	GSK Investigational Site	Muncie	Indiana	United States	47304-5547
205	GSK Investigational Site	Valparaiso	Indiana	United States	46383
206	GSK Investigational Site	Council Bluffs	Iowa	United States	51503
207	GSK Investigational Site	Dubuque	Iowa	United States	52001
208	GSK Investigational Site	Iowa City	Iowa	United States	52242
209	GSK Investigational Site	West Des Moines	Iowa	United States	50265
210	GSK Investigational Site	Newton	Kansas	United States	67114
211	GSK Investigational Site	Olathe	Kansas	United States	66061
212	GSK Investigational Site	Topeka	Kansas	United States	66606
213	GSK Investigational Site	Topeka	Kansas	United States	66615
214	GSK Investigational Site	Wichita	Kansas	United States	67218
215	GSK Investigational Site	Bowling Green	Kentucky	United States	42101
216	GSK Investigational Site	Crestview Hills	Kentucky	United States	41017
217	GSK Investigational Site	Hawesville	Kentucky	United States	42348
218	GSK Investigational Site	Hazard	Kentucky	United States	41701
219	GSK Investigational Site	Lexington	Kentucky	United States	40504
220	GSK Investigational Site	Louisville	Kentucky	United States	40202
221	GSK Investigational Site	Owensboro	Kentucky	United States	42303-3163
222	GSK Investigational Site	Lafayette	Louisiana	United States	70508
223	GSK Investigational Site	Metairie	Louisiana	United States	70006
224	GSK Investigational Site	Opelousas	Louisiana	United States	70570
225	GSK Investigational Site	Auburn	Maine	United States	04210
226	GSK Investigational Site	Bangor	Maine	United States	04401
227	GSK Investigational Site	Biddeford	Maine	United States	04005
228	GSK Investigational Site	Baltimore	Maryland	United States	21201
229	GSK Investigational Site	Baltimore	Maryland	United States	21224
230	GSK Investigational Site	Baltimore	Maryland	United States	21239
231	GSK Investigational Site	Columbia	Maryland	United States	21044
232	GSK Investigational Site	Elkton	Maryland	United States	21921
233	GSK Investigational Site	Hagerstown	Maryland	United States	21740
234	GSK Investigational Site	Hollywood	Maryland	United States	20636
235	GSK Investigational Site	Lutherville	Maryland	United States	21093
236	GSK Investigational Site	Oxon Hill	Maryland	United States	20745
237	GSK Investigational Site	Towson	Maryland	United States	21204
238	GSK Investigational Site	Brockton	Massachusetts	United States	02301
239	GSK Investigational Site	Fall River	Massachusetts	United States	02720
240	GSK Investigational Site	North Dartmouth	Massachusetts	United States	02747
241	GSK Investigational Site	Ann Arbor	Michigan	United States	48106
242	GSK Investigational Site	Buckley	Michigan	United States	49620
243	GSK Investigational Site	Cadillac	Michigan	United States	49601
244	GSK Investigational Site	Detroit	Michigan	United States	48201
245	GSK Investigational Site	Detroit	Michigan	United States	48221
246	GSK Investigational Site	Detroit	Michigan	United States	48235
247	GSK Investigational Site	Grand Blanc	Michigan	United States	48439
248	GSK Investigational Site	Kalamazoo	Michigan	United States	49009
249	GSK Investigational Site	Niles	Michigan	United States	49120
250	GSK Investigational Site	Rochester	Michigan	United States	48307
251	GSK Investigational Site	Royal Oak	Michigan	United States	48073-6769
252	GSK Investigational Site	Traverse City	Michigan	United States	49684
253	GSK Investigational Site	Troy	Michigan	United States	48085
254	GSK Investigational Site	Troy	Michigan	United States	48098
255	GSK Investigational Site	Coon Rapids	Minnesota	United States	55433
256	GSK Investigational Site	Edina	Minnesota	United States	55435
257	GSK Investigational Site	Fridley	Minnesota	United States	55432
258	GSK Investigational Site	Minneapolis	Minnesota	United States	55402
259	GSK Investigational Site	Minneapolis	Minnesota	United States	55407
260	GSK Investigational Site	Minneapolis	Minnesota	United States	55417
261	GSK Investigational Site	Plymouth	Minnesota	United States	55441
262	GSK Investigational Site	Rochester	Minnesota	United States	55905
263	GSK Investigational Site	Saint Paul	Minnesota	United States	55130
264	GSK Investigational Site	Woodbury	Minnesota	United States	55125
265	GSK Investigational Site	Chesterfield	Missouri	United States	63017
266	GSK Investigational Site	Kansas City	Missouri	United States	64106
267	GSK Investigational Site	Kansas City	Missouri	United States	64128
268	GSK Investigational Site	Saint Louis	Missouri	United States	63117
269	GSK Investigational Site	Saint Louis	Missouri	United States	63141
270	GSK Investigational Site	Saint Louis	Missouri	United States	63143
271	GSK Investigational Site	Billings	Montana	United States	59101
272	GSK Investigational Site	Billings	Montana	United States	59102
273	GSK Investigational Site	Butte	Montana	United States	59701
274	GSK Investigational Site	Great Falls	Montana	United States	59405
275	GSK Investigational Site	Missoula	Montana	United States	59808
276	GSK Investigational Site	Bellevue	Nebraska	United States	68123-4303
277	GSK Investigational Site	Fremont	Nebraska	United States	68025
278	GSK Investigational Site	Grand Island	Nebraska	United States	68803
279	GSK Investigational Site	Lincoln	Nebraska	United States	02865
280	GSK Investigational Site	Lincoln	Nebraska	United States	68506
281	GSK Investigational Site	Lincoln	Nebraska	United States	68512
282	GSK Investigational Site	Lincoln	Nebraska	United States	68516
283	GSK Investigational Site	Omaha	Nebraska	United States	68114
284	GSK Investigational Site	Omaha	Nebraska	United States	68134
285	GSK Investigational Site	Omaha	Nebraska	United States	68198
286	GSK Investigational Site	Henderson	Nevada	United States	89014
287	GSK Investigational Site	Las Vegas	Nevada	United States	89106
288	GSK Investigational Site	Las Vegas	Nevada	United States	89119
289	GSK Investigational Site	Reno	Nevada	United States	89502
290	GSK Investigational Site	Brick	New Jersey	United States	08723
291	GSK Investigational Site	Edison	New Jersey	United States	8820
292	GSK Investigational Site	Elizabeth	New Jersey	United States	07201
293	GSK Investigational Site	Elizabeth	New Jersey	United States	07202
294	GSK Investigational Site	Freehold	New Jersey	United States	07728
295	GSK Investigational Site	Linden	New Jersey	United States	07036
296	GSK Investigational Site	Lodi	New Jersey	United States	07644
297	GSK Investigational Site	Margate City	New Jersey	United States	08402
298	GSK Investigational Site	Princeton	New Jersey	United States	08540
299	GSK Investigational Site	Salem	New Jersey	United States	08079
300	GSK Investigational Site	Verona	New Jersey	United States	07044
301	GSK Investigational Site	Albuquerque	New Mexico	United States	87108
302	GSK Investigational Site	Albany	New York	United States	12208
303	GSK Investigational Site	Bronxville	New York	United States	10708
304	GSK Investigational Site	Bronx	New York	United States	10457
305	GSK Investigational Site	Bronx	New York	United States	10461
306	GSK Investigational Site	Brooklyn	New York	United States	11215
307	GSK Investigational Site	Brooklyn	New York	United States	11229
308	GSK Investigational Site	Buffalo	New York	United States	14215-1199
309	GSK Investigational Site	Corning	New York	United States	14830
310	GSK Investigational Site	Great Neck	New York	United States	11023
311	GSK Investigational Site	Manhattan	New York	United States	10029
312	GSK Investigational Site	Massapequa	New York	United States	11758
313	GSK Investigational Site	New York	New York	United States	10001
314	GSK Investigational Site	New York	New York	United States	10004
315	GSK Investigational Site	New York	New York	United States	10009
316	GSK Investigational Site	New York	New York	United States	10016
317	GSK Investigational Site	New York	New York	United States	10019
318	GSK Investigational Site	New York	New York	United States	10021
319	GSK Investigational Site	New York	New York	United States	10028
320	GSK Investigational Site	New York	New York	United States	10038
321	GSK Investigational Site	Rochester	New York	United States	14618
322	GSK Investigational Site	Syracuse	New York	United States	13210
323	GSK Investigational Site	Westfield	New York	United States	14787
324	GSK Investigational Site	Asheville	North Carolina	United States	28801
325	GSK Investigational Site	Calabash	North Carolina	United States	28467
326	GSK Investigational Site	Charlotte	North Carolina	United States	28209
327	GSK Investigational Site	Charlotte	North Carolina	United States	28210
328	GSK Investigational Site	Elizabeth City	North Carolina	United States	27909
329	GSK Investigational Site	Greensboro	North Carolina	United States	27401
330	GSK Investigational Site	Greensboro	North Carolina	United States	27403
331	GSK Investigational Site	Greensboro	North Carolina	United States	27405
332	GSK Investigational Site	Greensboro	North Carolina	United States	27408
333	GSK Investigational Site	Greenville	North Carolina	United States	27858
334	GSK Investigational Site	High Point	North Carolina	United States	27262
335	GSK Investigational Site	Huntersville	North Carolina	United States	28078
336	GSK Investigational Site	Knightdale	North Carolina	United States	27545
337	GSK Investigational Site	Lexington	North Carolina	United States	27295
338	GSK Investigational Site	Morganton	North Carolina	United States	28655
339	GSK Investigational Site	Salisbury	North Carolina	United States	28144
340	GSK Investigational Site	Shelby	North Carolina	United States	28152
341	GSK Investigational Site	Smithfield	North Carolina	United States	27577
342	GSK Investigational Site	Statesville	North Carolina	United States	28625
343	GSK Investigational Site	Wilmington	North Carolina	United States	28401
344	GSK Investigational Site	Winston-Salem	North Carolina	United States	27103
345	GSK Investigational Site	Akron	Ohio	United States	44313
346	GSK Investigational Site	Chardon	Ohio	United States	44024
347	GSK Investigational Site	Cincinnati	Ohio	United States	45220
348	GSK Investigational Site	Cincinnati	Ohio	United States	45231
349	GSK Investigational Site	Cincinnati	Ohio	United States	45242
350	GSK Investigational Site	Cleveland	Ohio	United States	44106
351	GSK Investigational Site	Cleveland	Ohio	United States	44109
352	GSK Investigational Site	Cleveland	Ohio	United States	44122
353	GSK Investigational Site	Columbus	Ohio	United States	43213
354	GSK Investigational Site	Columbus	Ohio	United States	43214
355	GSK Investigational Site	Columbus	Ohio	United States	43215
356	GSK Investigational Site	Columbus	Ohio	United States	43235
357	GSK Investigational Site	Dayton	Ohio	United States	45406
358	GSK Investigational Site	Dayton	Ohio	United States	45459
359	GSK Investigational Site	Kettering	Ohio	United States	45429
360	GSK Investigational Site	Marion	Ohio	United States	43302
361	GSK Investigational Site	Maumee	Ohio	United States	43537-9402
362	GSK Investigational Site	Miamisburg	Ohio	United States	45342
363	GSK Investigational Site	Toledo	Ohio	United States	43606
364	GSK Investigational Site	Toledo	Ohio	United States	43614-5809
365	GSK Investigational Site	Toledo	Ohio	United States	43617
366	GSK Investigational Site	Wooster	Ohio	United States	44691
367	GSK Investigational Site	Youngstown	Ohio	United States	44501
368	GSK Investigational Site	Oklahoma City	Oklahoma	United States	73103
369	GSK Investigational Site	Tulsa	Oklahoma	United States	74127
370	GSK Investigational Site	Tulsa	Oklahoma	United States	74136
371	GSK Investigational Site	Bend	Oregon	United States	97701
372	GSK Investigational Site	Portland	Oregon	United States	97202
373	GSK Investigational Site	Portland	Oregon	United States	97219
374	GSK Investigational Site	Springfield	Oregon	United States	97477
375	GSK Investigational Site	Beaver	Pennsylvania	United States	15009
376	GSK Investigational Site	Belle Vernon	Pennsylvania	United States	15012
377	GSK Investigational Site	Bensalem	Pennsylvania	United States	19020
378	GSK Investigational Site	Clairton	Pennsylvania	United States	15025
379	GSK Investigational Site	Downingtown	Pennsylvania	United States	19335
380	GSK Investigational Site	Doylestown	Pennsylvania	United States	18901
381	GSK Investigational Site	Erie	Pennsylvania	United States	16508
382	GSK Investigational Site	Fleetwood	Pennsylvania	United States	19522
383	GSK Investigational Site	Harleysville	Pennsylvania	United States	19438
384	GSK Investigational Site	Jersey Shore	Pennsylvania	United States	17740
385	GSK Investigational Site	Langhorne	Pennsylvania	United States	19047
386	GSK Investigational Site	Lansdale	Pennsylvania	United States	19446
387	GSK Investigational Site	Monroeville	Pennsylvania	United States	15146
388	GSK Investigational Site	Philadelphia	Pennsylvania	United States	19107
389	GSK Investigational Site	Philadelphia	Pennsylvania	United States	19140
390	GSK Investigational Site	Philadelphia	Pennsylvania	United States	19142
391	GSK Investigational Site	Philadelphia	Pennsylvania	United States	19152
392	GSK Investigational Site	Phoenixville	Pennsylvania	United States	19460
393	GSK Investigational Site	Pittsburgh	Pennsylvania	United States	15213
394	GSK Investigational Site	Pittsburgh	Pennsylvania	United States	15236
395	GSK Investigational Site	Pittsburgh	Pennsylvania	United States	15243
396	GSK Investigational Site	Scottdale	Pennsylvania	United States	15683
397	GSK Investigational Site	Scranton	Pennsylvania	United States	18501
398	GSK Investigational Site	Uniontown	Pennsylvania	United States	15401
399	GSK Investigational Site	Warminster	Pennsylvania	United States	18974
400	GSK Investigational Site	Cumberland	Rhode Island	United States	02864
401	GSK Investigational Site	East Providence	Rhode Island	United States	02914
402	GSK Investigational Site	Johnston	Rhode Island	United States	02919
403	GSK Investigational Site	Anderson	South Carolina	United States	29621
404	GSK Investigational Site	Charleston	South Carolina	United States	29406-7108
405	GSK Investigational Site	Charleston	South Carolina	United States	29407
406	GSK Investigational Site	Columbia	South Carolina	United States	29201
407	GSK Investigational Site	Columbia	South Carolina	United States	29209
408	GSK Investigational Site	Easley	South Carolina	United States	29640
409	GSK Investigational Site	Florence	South Carolina	United States	29501
410	GSK Investigational Site	Gaffney	South Carolina	United States	29340
411	GSK Investigational Site	Greenville	South Carolina	United States	29615
412	GSK Investigational Site	Greenwood	South Carolina	United States	29646
413	GSK Investigational Site	Greer	South Carolina	United States	29650
414	GSK Investigational Site	Greer	South Carolina	United States	29651
415	GSK Investigational Site	Indian Land	South Carolina	United States	29707
416	GSK Investigational Site	Murrells Inlet	South Carolina	United States	29576
417	GSK Investigational Site	Pelzer	South Carolina	United States	29669
418	GSK Investigational Site	Rock Hill	South Carolina	United States	29732
419	GSK Investigational Site	Spartanburg	South Carolina	United States	29303
420	GSK Investigational Site	Williamston	South Carolina	United States	29697
421	GSK Investigational Site	Dakota Dunes	South Dakota	United States	57049
422	GSK Investigational Site	Rapid City	South Dakota	United States	57702
423	GSK Investigational Site	Chattanooga	Tennessee	United States	37404
424	GSK Investigational Site	Fayetteville	Tennessee	United States	37334
425	GSK Investigational Site	Franklin	Tennessee	United States	27064
426	GSK Investigational Site	Nashville	Tennessee	United States	37215
427	GSK Investigational Site	Shelbyville	Tennessee	United States	37160
428	GSK Investigational Site	Amarillo	Texas	United States	79124
429	GSK Investigational Site	Austin	Texas	United States	78756
430	GSK Investigational Site	Austin	Texas	United States	78758
431	GSK Investigational Site	Boerne	Texas	United States	78006
432	GSK Investigational Site	Corpus Christi	Texas	United States	78405
433	GSK Investigational Site	Corsicana	Texas	United States	75110
434	GSK Investigational Site	Dallas	Texas	United States	75216
435	GSK Investigational Site	Dallas	Texas	United States	75225
436	GSK Investigational Site	Dallas	Texas	United States	75246
437	GSK Investigational Site	Dallas	Texas	United States	75254
438	GSK Investigational Site	Duncanville	Texas	United States	75116
439	GSK Investigational Site	Edinburg	Texas	United States	78539
440	GSK Investigational Site	Fort Worth	Texas	United States	76104
441	GSK Investigational Site	Frisco	Texas	United States	75034
442	GSK Investigational Site	Frisco	Texas	United States	75035
443	GSK Investigational Site	Galveston	Texas	United States	77555
444	GSK Investigational Site	Georgetown	Texas	United States	78626
445	GSK Investigational Site	Houston	Texas	United States	77024
446	GSK Investigational Site	Houston	Texas	United States	77025
447	GSK Investigational Site	Houston	Texas	United States	77029
448	GSK Investigational Site	Houston	Texas	United States	77030
449	GSK Investigational Site	Houston	Texas	United States	77034
450	GSK Investigational Site	Houston	Texas	United States	77043
451	GSK Investigational Site	Houston	Texas	United States	77062
452	GSK Investigational Site	Houston	Texas	United States	77074
453	GSK Investigational Site	Houston	Texas	United States	77077
454	GSK Investigational Site	Houston	Texas	United States	77079
455	GSK Investigational Site	Houston	Texas	United States	77081
456	GSK Investigational Site	Houston	Texas	United States	77099
457	GSK Investigational Site	Huntsville	Texas	United States	77340
458	GSK Investigational Site	Irving	Texas	United States	75039
459	GSK Investigational Site	Killeen	Texas	United States	76543
460	GSK Investigational Site	Kingwood	Texas	United States	77339
461	GSK Investigational Site	Lewisville	Texas	United States	75067
462	GSK Investigational Site	Longview	Texas	United States	75605
463	GSK Investigational Site	Lufkin	Texas	United States	75904
464	GSK Investigational Site	McKinney	Texas	United States	75069
465	GSK Investigational Site	McKinney	Texas	United States	75071
466	GSK Investigational Site	Plano	Texas	United States	75075
467	GSK Investigational Site	San Angelo	Texas	United States	76904
468	GSK Investigational Site	San Antonio	Texas	United States	78212
469	GSK Investigational Site	San Antonio	Texas	United States	78215
470	GSK Investigational Site	San Antonio	Texas	United States	78229
471	GSK Investigational Site	San Antonio	Texas	United States	78233
472	GSK Investigational Site	San Antonio	Texas	United States	78258
473	GSK Investigational Site	Sugar Land	Texas	United States	77478
474	GSK Investigational Site	Temple	Texas	United States	76508
475	GSK Investigational Site	Tyler	Texas	United States	75701
476	GSK Investigational Site	Tyler	Texas	United States	75708
477	GSK Investigational Site	Victoria	Texas	United States	77901
478	GSK Investigational Site	Waco	Texas	United States	76710
479	GSK Investigational Site	Midvale	Utah	United States	84047
480	GSK Investigational Site	Orem	Utah	United States	84058
481	GSK Investigational Site	Salt Lake City	Utah	United States	84102
482	GSK Investigational Site	West Jordan	Utah	United States	84088
483	GSK Investigational Site	Abingdon	Virginia	United States	24210
484	GSK Investigational Site	Alexandria	Virginia	United States	22304
485	GSK Investigational Site	Burke	Virginia	United States	22015
486	GSK Investigational Site	Midlothian	Virginia	United States	23114
487	GSK Investigational Site	Norfolk	Virginia	United States	23507
488	GSK Investigational Site	Richmond	Virginia	United States	23219
489	GSK Investigational Site	Richmond	Virginia	United States	23220
490	GSK Investigational Site	Richmond	Virginia	United States	23229
491	GSK Investigational Site	Richmond	Virginia	United States	23235
492	GSK Investigational Site	Richmond	Virginia	United States	23249
493	GSK Investigational Site	Virginia Beach	Virginia	United States	23454
494	GSK Investigational Site	Winchester	Virginia	United States	22601
495	GSK Investigational Site	Bellingham	Washington	United States	98225
496	GSK Investigational Site	Burien	Washington	United States	98166
497	GSK Investigational Site	Seattle	Washington	United States	98104
498	GSK Investigational Site	Spokane	Washington	United States	99202
499	GSK Investigational Site	Spokane	Washington	United States	99204
500	GSK Investigational Site	Spokane	Washington	United States	99207
501	GSK Investigational Site	Spokane	Washington	United States	99208
502	GSK Investigational Site	Tacoma	Washington	United States	98405
503	GSK Investigational Site	Bridgeport	West Virginia	United States	26330
504	GSK Investigational Site	Morgantown	West Virginia	United States	26505
505	GSK Investigational Site	Morgantown	West Virginia	United States	28506
506	GSK Investigational Site	West Allis	Wisconsin	United States	53227
507	GSK Investigational Site	Adrogue	Buenos Aires	Argentina	B1846DSK
508	GSK Investigational Site	Bahia Blanca	Buenos Aires	Argentina	B8000FTD
509	GSK Investigational Site	Ciudad Autnónoma de Buenos Aires	Buenos Aires	Argentina	C1186ACB
510	GSK Investigational Site	Ciudad Autonoma de Buenos Aires	Buenos Aires	Argentina	C1028AAP
511	GSK Investigational Site	Ciudad Autonoma de Buenos Aires	Buenos Aires	Argentina	C1122AAK
512	GSK Investigational Site	Ciudad Autonoma de Buenos Aires	Buenos Aires	Argentina	C1405BCH
513	GSK Investigational Site	Derqui, Pilar	Buenos Aires	Argentina	B1629AHJ
514	GSK Investigational Site	Florencio Varela	Buenos Aires	Argentina	1888
515	GSK Investigational Site	La Plata	Buenos Aires	Argentina	1900
516	GSK Investigational Site	La Plata	Buenos Aires	Argentina	B1900AXI
517	GSK Investigational Site	Mar del Plata	Buenos Aires	Argentina	B7600FZN
518	GSK Investigational Site	Nueve de Julio	Buenos Aires	Argentina	B6500BWQ
519	GSK Investigational Site	Olivos	Buenos Aires	Argentina	B1605DSX
520	GSK Investigational Site	Pergamino	Buenos Aires	Argentina	B2700CPM
521	GSK Investigational Site	Quilmes	Buenos Aires	Argentina	1878
522	GSK Investigational Site	Quilmes	Buenos Aires	Argentina	B1878FNR
523	GSK Investigational Site	San Isidro	Buenos Aires	Argentina	B1642DCD
524	GSK Investigational Site	San Martin	Buenos Aires	Argentina	1650
525	GSK Investigational Site	San Nicolas	Buenos Aires	Argentina	B2900DMH
526	GSK Investigational Site	San Nicolas	Buenos Aires	Argentina	B2900IIC
527	GSK Investigational Site	Vicente López	Buenos Aires	Argentina	1602
528	GSK Investigational Site	Cordoba	Córdova	Argentina	X5000AAW
529	GSK Investigational Site	Cordoba	Córdova	Argentina	X5003DCE
530	GSK Investigational Site	Concepcion del Uruguay	Entre Ríos	Argentina	3260
531	GSK Investigational Site	Parana	Entre Ríos	Argentina	E3100BHK
532	GSK Investigational Site	Godoy Cruz	Mendoza	Argentina	5501
533	GSK Investigational Site	Cipoletti, Rio Negro	Río Negro	Argentina	R8324CVE
534	GSK Investigational Site	Rosario	Santa Fe	Argentina	2000
535	GSK Investigational Site	Rosario	Santa Fe	Argentina	S2000BIF
536	GSK Investigational Site	Rosario	Santa Fe	Argentina	S2000CVD
537	GSK Investigational Site	Rosario	Santa Fe	Argentina	S2002OJN
538	GSK Investigational Site	Rosario	Santa Fe	Argentina	S2005PAF
539	GSK Investigational Site	Tucuman	Tucumán	Argentina	4000
540	GSK Investigational Site	Buenos Aires		Argentina	B1704ETD
541	GSK Investigational Site	Buenos Aires		Argentina	C1061ABD
542	GSK Investigational Site	Buenos Aires		Argentina	C1120AAC
543	GSK Investigational Site	Buenos Aires		Argentina	C1280AEB
544	GSK Investigational Site	Buenos Aires		Argentina	C1407HUF
545	GSK Investigational Site	Buenos Aires		Argentina	C1425AGC
546	GSK Investigational Site	Buenos Aires		Argentina	C1425FVH
547	GSK Investigational Site	Buenos Aires		Argentina	C1437BZ
548	GSK Investigational Site	Ciudad Autonoma de Buenos Aires		Argentina	C1425BEN
549	GSK Investigational Site	Ciudad Autónoma de Buenos Aires		Argentina	C1426ABP
550	GSK Investigational Site	Cordoba		Argentina	5000
551	GSK Investigational Site	Cordoba		Argentina	5016
552	GSK Investigational Site	Cordoba		Argentina	5900
553	GSK Investigational Site	Cordoba		Argentina	X5003DCE
554	GSK Investigational Site	Cordoba		Argentina	X5004BAL
555	GSK Investigational Site	Cordoba		Argentina	X5006
556	GSK Investigational Site	Coronel Suarez		Argentina	7540
557	GSK Investigational Site	Corrientes		Argentina	W3400AVK
558	GSK Investigational Site	Florencio Varela		Argentina	C1073ABA
559	GSK Investigational Site	Formosa		Argentina	3600
560	GSK Investigational Site	Jujuy		Argentina	4600
561	GSK Investigational Site	Lanús		Argentina	B1824KAJ
562	GSK Investigational Site	Mar del Plata		Argentina	B7600FYK
563	GSK Investigational Site	Mendoza		Argentina	5500
564	GSK Investigational Site	Mendoza		Argentina	M5500CCG
565	GSK Investigational Site	Mendoza		Argentina	MM5500
566	GSK Investigational Site	Monte Grande		Argentina	1842
567	GSK Investigational Site	Rosario		Argentina	2000
568	GSK Investigational Site	Rosario		Argentina	S2000CXP
569	GSK Investigational Site	Salta		Argentina	A4400ANG
570	GSK Investigational Site	Salta		Argentina	A4400ERH
571	GSK Investigational Site	San Luis		Argentina	5700
572	GSK Investigational Site	San Miguel de Tucuman		Argentina	4000
573	GSK Investigational Site	San Miguel de Tucumán		Argentina	4000
574	GSK Investigational Site	Santa Fe		Argentina	3000
575	GSK Investigational Site	Santa Fe		Argentina	3016
576	GSK Investigational Site	Santiago del Estero		Argentina
577	GSK Investigational Site	Cairns	Queensland	Australia	4870
578	GSK Investigational Site	Redcliffe	Queensland	Australia	4020
579	GSK Investigational Site	Bedford Park	South Australia	Australia	5042
580	GSK Investigational Site	Daw Park	South Australia	Australia	5041
581	GSK Investigational Site	Footscray	Victoria	Australia	3011
582	GSK Investigational Site	Geelong	Victoria	Australia	3220
583	GSK Investigational Site	Melbourne	Victoria	Australia	3004
584	GSK Investigational Site	Glen Osmond		Australia	5064
585	GSK Investigational Site	Feldbach		Austria	8330
586	GSK Investigational Site	Feldkirch		Austria	6800
587	GSK Investigational Site	Grieskirchen		Austria	A-4710
588	GSK Investigational Site	Innsbruck		Austria	A-6020
589	GSK Investigational Site	Linz		Austria	4020
590	GSK Investigational Site	Salzburg		Austria	5020
591	GSK Investigational Site	Salzburg		Austria	A-5020
592	GSK Investigational Site	Spittal/Drau		Austria	9800
593	GSK Investigational Site	Thalheim bei Wels		Austria	4600
594	GSK Investigational Site	Vienna		Austria	A-1120
595	GSK Investigational Site	Wels		Austria	4600
596	GSK Investigational Site	Zwettl		Austria	3910
597	GSK Investigational Site	Brest		Belarus	224027
598	GSK Investigational Site	Gomel		Belarus	246040
599	GSK Investigational Site	Grodno		Belarus	230017
600	GSK Investigational Site	Minsk		Belarus	220030
601	GSK Investigational Site	Minsk		Belarus	220053
602	GSK Investigational Site	Minsk		Belarus	223041
603	GSK Investigational Site	Vitebsk		Belarus	210037
604	GSK Investigational Site	Diest		Belgium	3290
605	GSK Investigational Site	Erpent		Belgium	5101
606	GSK Investigational Site	Gilly		Belgium	6060
607	GSK Investigational Site	Mons		Belgium	7000
608	GSK Investigational Site	Namur		Belgium	5000
609	GSK Investigational Site	Banja Luka		Bosnia and Herzegovina	78000
610	GSK Investigational Site	Banjaluka		Bosnia and Herzegovina	78000
611	GSK Investigational Site	Bihac		Bosnia and Herzegovina	77 000
612	GSK Investigational Site	Bihac		Bosnia and Herzegovina	77000
613	GSK Investigational Site	Bijeljina		Bosnia and Herzegovina	76300
614	GSK Investigational Site	Brcko		Bosnia and Herzegovina	76000
615	GSK Investigational Site	Foca		Bosnia and Herzegovina	73300
616	GSK Investigational Site	Gracanica		Bosnia and Herzegovina	75320
617	GSK Investigational Site	Gradiska		Bosnia and Herzegovina	78400
618	GSK Investigational Site	Istocno Sarajevo		Bosnia and Herzegovina	71123
619	GSK Investigational Site	Konjic		Bosnia and Herzegovina	88400
620	GSK Investigational Site	Mostar		Bosnia and Herzegovina	88000
621	GSK Investigational Site	Novi Travnik		Bosnia and Herzegovina
622	GSK Investigational Site	Pale		Bosnia and Herzegovina	71420
623	GSK Investigational Site	Sarajevo		Bosnia and Herzegovina	71000
624	GSK Investigational Site	Sarajevo		Bosnia and Herzegovina	71320
625	GSK Investigational Site	Srebrenik		Bosnia and Herzegovina	75350
626	GSK Investigational Site	Tesanj		Bosnia and Herzegovina	74260
627	GSK Investigational Site	Teslić		Bosnia and Herzegovina	74270
628	GSK Investigational Site	Travnik		Bosnia and Herzegovina	72270
629	GSK Investigational Site	Trebinje		Bosnia and Herzegovina	89101
630	GSK Investigational Site	Tuzla		Bosnia and Herzegovina	75000
631	GSK Investigational Site	Visegrad		Bosnia and Herzegovina	73240
632	GSK Investigational Site	Zenica		Bosnia and Herzegovina	72000
633	GSK Investigational Site	Blagoevgrad		Bulgaria	2700
634	GSK Investigational Site	Dimitrovgrad		Bulgaria	6400
635	GSK Investigational Site	Gabrovo		Bulgaria	5300
636	GSK Investigational Site	Kozlodui		Bulgaria	3320
637	GSK Investigational Site	Lovech		Bulgaria	5500
638	GSK Investigational Site	Pazardjik		Bulgaria	4400
639	GSK Investigational Site	Petrich		Bulgaria	2850
640	GSK Investigational Site	Pleven		Bulgaria	5800
641	GSK Investigational Site	Plovdiv		Bulgaria	4002
642	GSK Investigational Site	Razgrad		Bulgaria	7200
643	GSK Investigational Site	Rousse		Bulgaria	7000
644	GSK Investigational Site	Sevlievo		Bulgaria	5400
645	GSK Investigational Site	Sliven		Bulgaria	8800
646	GSK Investigational Site	Sofia		Bulgaria	1000
647	GSK Investigational Site	Sofia		Bulgaria	1142
648	GSK Investigational Site	Sofia		Bulgaria	1202
649	GSK Investigational Site	Sofia		Bulgaria	1233
650	GSK Investigational Site	Sofia		Bulgaria	1336
651	GSK Investigational Site	Sofia		Bulgaria	1431
652	GSK Investigational Site	Sofia		Bulgaria	1505
653	GSK Investigational Site	Sofia		Bulgaria	1606
654	GSK Investigational Site	Sofia		Bulgaria	1618
655	GSK Investigational Site	Sofia		Bulgaria	1784
656	GSK Investigational Site	Stara Zagora		Bulgaria	6000
657	GSK Investigational Site	Stara Zagora		Bulgaria	6003
658	GSK Investigational Site	Troyan		Bulgaria	5600
659	GSK Investigational Site	Varna		Bulgaria	9000
660	GSK Investigational Site	Veliko Tarnovo		Bulgaria	5000
661	GSK Investigational Site	Vidin		Bulgaria	3700
662	GSK Investigational Site	Edmonton	Alberta	Canada	T5A 4L8
663	GSK Investigational Site	Edmonton	Alberta	Canada	T5J 3S9
664	GSK Investigational Site	Kamloops	British Columbia	Canada	V2C 1K7
665	GSK Investigational Site	Penticton	British Columbia	Canada	V2A 5C8
666	GSK Investigational Site	Vancouver	British Columbia	Canada	V5Z 4E1
667	GSK Investigational Site	West Vancouver	British Columbia	Canada	V7T 2Z3
668	GSK Investigational Site	Winnipeg	Manitoba	Canada	R3H 2A6
669	GSK Investigational Site	Bolton	Ontario	Canada	L7E 4C8
670	GSK Investigational Site	Burlington	Ontario	Canada	L7N 3V2
671	GSK Investigational Site	Grimsby	Ontario	Canada	L3M 1P3
672	GSK Investigational Site	London	Ontario	Canada	N5Y 5K7
673	GSK Investigational Site	Mississauga	Ontario	Canada	L4T 4J2
674	GSK Investigational Site	Mississauga	Ontario	Canada	L5M 2V8
675	GSK Investigational Site	Newmarket	Ontario	Canada	L3Y 5G8
676	GSK Investigational Site	Orleans	Ontario	Canada	K4A 5E6
677	GSK Investigational Site	Sarnia	Ontario	Canada	N7T 4X3
678	GSK Investigational Site	Toronto	Ontario	Canada	M5T 3A9
679	GSK Investigational Site	Windsor	Ontario	Canada	N8X 5A6
680	GSK Investigational Site	Mirabel	Quebec	Canada	J7J 2K8
681	GSK Investigational Site	Montreal	Quebec	Canada	H2W1T8
682	GSK Investigational Site	Sainte Jerome	Quebec	Canada	J7Z 5T3
683	GSK Investigational Site	Quebec		Canada	G1G 4A2
684	GSK Investigational Site	Temuco	Región De La Araucania	Chile	4800798
685	GSK Investigational Site	Temuco	Región De La Araucania	Chile
686	GSK Investigational Site	Santiago	Región Metro De Santiago	Chile	7500691
687	GSK Investigational Site	Santiago	Región Metro De Santiago	Chile	8910131
688	GSK Investigational Site	Santiago	Región Metro De Santiago	Chile
689	GSK Investigational Site	Viña del Mar	Valparaíso	Chile	2340000
690	GSK Investigational Site	Guangzhou	Guangdong	China	510080
691	GSK Investigational Site	Guangzhou	Guangdong	China	510120
692	GSK Investigational Site	Guangzhou	Guangdong	China	510515
693	GSK Investigational Site	Shenzhen	Guangdong	China	518020
694	GSK Investigational Site	Zhanjiang	Guangdong	China	524001
695	GSK Investigational Site	Nanning	Guangxi	China	530021
696	GSK Investigational Site	Haikou	Hainan	China	570001
697	GSK Investigational Site	Haikou	Hainan	China	570311
698	GSK Investigational Site	Hohhot	Hainan	China	010050
699	GSK Investigational Site	Shijiazhuang	Hebei	China	050000
700	GSK Investigational Site	Wuhan	Hubei	China	430060
701	GSK Investigational Site	Baotou	Inner Mongolia	China	014010
702	GSK Investigational Site	Shenyang	Liaoning	China	110004
703	GSK Investigational Site	Yinchuan	Ningxia	China	750004
704	GSK Investigational Site	Xian	Shaanxi	China	710032
705	GSK Investigational Site	Jinan	Shandong	China	250033
706	GSK Investigational Site	Taiyuan	Shanxi	China	030001
707	GSK Investigational Site	Chengdu	Sichuan	China	610083
708	GSK Investigational Site	Baotou		China
709	GSK Investigational Site	Beijing		China	100020
710	GSK Investigational Site	Beijing		China	100029
711	GSK Investigational Site	Beijing		China	100050
712	GSK Investigational Site	Beijing		China	100070
713	GSK Investigational Site	Beijing		China	100144
714	GSK Investigational Site	Bengbu		China	233000
715	GSK Investigational Site	Changchun		China	130012
716	GSK Investigational Site	Chengdu		China	610041
717	GSK Investigational Site	Chongqing		China	400016
718	GSK Investigational Site	Chongqing		China	400038
719	GSK Investigational Site	Chongqing		China	400042
720	GSK Investigational Site	Fu Zhou		China
721	GSK Investigational Site	Fuzhou		China	350025
722	GSK Investigational Site	Guangxi		China	530021
723	GSK Investigational Site	Guangzhou		China	510080
724	GSK Investigational Site	Hangzhou		China	310014
725	GSK Investigational Site	Hefei		China	230001
726	GSK Investigational Site	Huai'an		China	223300
727	GSK Investigational Site	Jiangyin		China
728	GSK Investigational Site	Luzhou		China
729	GSK Investigational Site	Nanchang		China	330006
730	GSK Investigational Site	Nanjing		China	210009
731	GSK Investigational Site	Shanghai		China	200003
732	GSK Investigational Site	Shanghai		China	200025
733	GSK Investigational Site	Shanghai		China	200032
734	GSK Investigational Site	Shanghai		China	200040
735	GSK Investigational Site	ShangHai		China	200062
736	GSK Investigational Site	Shanghai		China	200072
737	GSK Investigational Site	Shanghai		China	200433
738	GSK Investigational Site	Tianjin		China	300121
739	GSK Investigational Site	Wuxi		China	214023
740	GSK Investigational Site	Barranquilla		Colombia
741	GSK Investigational Site	Bogota		Colombia	111211
742	GSK Investigational Site	Bogota		Colombia
743	GSK Investigational Site	Bogotá		Colombia	80CO
744	GSK Investigational Site	Bogotá		Colombia
745	GSK Investigational Site	Cali		Colombia	571
746	GSK Investigational Site	Medellin		Colombia	80372
747	GSK Investigational Site	Medellin		Colombia
748	GSK Investigational Site	Zipaquira		Colombia
749	GSK Investigational Site	Cakovec		Croatia	40000
750	GSK Investigational Site	Draganic		Croatia	47201
751	GSK Investigational Site	Hrasce Turopoljsko		Croatia	10020
752	GSK Investigational Site	Hreljin		Croatia	51226
753	GSK Investigational Site	Ivankovo		Croatia	32281
754	GSK Investigational Site	Karlovac		Croatia	47000
755	GSK Investigational Site	Klenovnik		Croatia	42244
756	GSK Investigational Site	Krapina		Croatia	49000
757	GSK Investigational Site	Kutina		Croatia	44320
758	GSK Investigational Site	Novi Marof		Croatia	42220
759	GSK Investigational Site	Osijek		Croatia	31000
760	GSK Investigational Site	Retkovci		Croatia	32282
761	GSK Investigational Site	Rijeka		Croatia	51000
762	GSK Investigational Site	Samobor		Croatia	10430
763	GSK Investigational Site	Senj		Croatia	53270
764	GSK Investigational Site	Sibenik		Croatia	22000
765	GSK Investigational Site	Sisak		Croatia	44000
766	GSK Investigational Site	Split		Croatia	21000
767	GSK Investigational Site	Strmec Samoborski		Croatia	10434
768	GSK Investigational Site	Stubicke toplice		Croatia	49244
769	GSK Investigational Site	Sukosan		Croatia	23206
770	GSK Investigational Site	Varazdin		Croatia	42000
771	GSK Investigational Site	Zabok		Croatia	49210
772	GSK Investigational Site	Zadar		Croatia	23000
773	GSK Investigational Site	Zagreb		Croatia	10000
774	GSK Investigational Site	Benesov		Czechia	256 01
775	GSK Investigational Site	Beroun		Czechia	266 01
776	GSK Investigational Site	Brno		Czechia	612 00
777	GSK Investigational Site	Havlickuv brod		Czechia	580 01
778	GSK Investigational Site	Hlucin		Czechia	748 01
779	GSK Investigational Site	Holesov		Czechia	769 01
780	GSK Investigational Site	Jaromer		Czechia	551 01
781	GSK Investigational Site	Jindrichuv Hradec		Czechia	377 01
782	GSK Investigational Site	Kolin		Czechia	280 00
783	GSK Investigational Site	Kralupy nad Vltavou		Czechia	278 01
784	GSK Investigational Site	Kromeriz		Czechia	767 01
785	GSK Investigational Site	Liberec		Czechia	460 01
786	GSK Investigational Site	Melnik		Czechia	276 01
787	GSK Investigational Site	Moravsky Krumlov		Czechia	672 01
788	GSK Investigational Site	Neratovice		Czechia	277 11
789	GSK Investigational Site	Novy Jicin		Czechia	741 01
790	GSK Investigational Site	Ostrava - Belsky les		Czechia	700 30
791	GSK Investigational Site	Ostrava - Poruba		Czechia	70868
792	GSK Investigational Site	Ostrava		Czechia	72880
793	GSK Investigational Site	Plzen		Czechia	301 00
794	GSK Investigational Site	Plzen		Czechia	323 00
795	GSK Investigational Site	Praha 13		Czechia	158 00
796	GSK Investigational Site	Praha 17		Czechia	163 00
797	GSK Investigational Site	Praha 1		Czechia	110 00
798	GSK Investigational Site	Praha 3		Czechia	130 00
799	GSK Investigational Site	Praha 4		Czechia	140 00
800	GSK Investigational Site	Praha 4		Czechia	140 46
801	GSK Investigational Site	Praha 5		Czechia	150 00
802	GSK Investigational Site	Praha 6		Czechia	169 00
803	GSK Investigational Site	Rokycany		Czechia	337 01
804	GSK Investigational Site	Rudna		Czechia	252 19
805	GSK Investigational Site	Strakonice		Czechia	386 01
806	GSK Investigational Site	Strakonice		Czechia	386 29
807	GSK Investigational Site	Svitavy		Czechia	568 25
808	GSK Investigational Site	Tremosna		Czechia	330 11
809	GSK Investigational Site	Usti Nad Labem - Klise		Czechia	400 01
810	GSK Investigational Site	Zatec		Czechia	438 01
811	GSK Investigational Site	Ferolles Attilly		France	77150
812	GSK Investigational Site	Paris Cedex 04		France	75181
813	GSK Investigational Site	Strasbourg Cedex		France	67091
814	GSK Investigational Site	Tarbes		France	65013
815	GSK Investigational Site	Toulouse cedex 9		France	31059
816	GSK Investigational Site	Batumi		Georgia	6000
817	GSK Investigational Site	Gurjaani		Georgia	1500
818	GSK Investigational Site	Kutaisi		Georgia	1600
819	GSK Investigational Site	Kvemo Kartli		Georgia	3000
820	GSK Investigational Site	Tbilisi		Georgia	0101
821	GSK Investigational Site	Tbilisi		Georgia	0102
822	GSK Investigational Site	Tbilisi		Georgia	0114
823	GSK Investigational Site	Tbilisi		Georgia	0141
824	GSK Investigational Site	Tbilisi		Georgia	0144
825	GSK Investigational Site	Tbilisi		Georgia	0159
826	GSK Investigational Site	Tbilisi		Georgia	0160
827	GSK Investigational Site	Tbilisi		Georgia	0177
828	GSK Investigational Site	Tbilisi		Georgia	0186
829	GSK Investigational Site	Tbilisi		Georgia	0191
830	GSK Investigational Site	Tbilisi		Georgia
831	GSK Investigational Site	Bruchsal	Baden-Wuerttemberg	Germany	76646
832	GSK Investigational Site	Deggingen	Baden-Wuerttemberg	Germany	73326
833	GSK Investigational Site	Ettlingen	Baden-Wuerttemberg	Germany	76275
834	GSK Investigational Site	Frankfurt	Baden-Wuerttemberg	Germany	60596
835	GSK Investigational Site	Karlsruhe	Baden-Wuerttemberg	Germany	76227
836	GSK Investigational Site	Aschaffenburg	Bayern	Germany	63739
837	GSK Investigational Site	Augsburg	Bayern	Germany	86150
838	GSK Investigational Site	Augsburg	Bayern	Germany	86156
839	GSK Investigational Site	Bad Woerrishofen	Bayern	Germany	86825
840	GSK Investigational Site	Feldkirchen	Bayern	Germany	83620
841	GSK Investigational Site	Fuerth	Bayern	Germany	90762
842	GSK Investigational Site	Gauting	Bayern	Germany	82131
843	GSK Investigational Site	Hoechstadt	Bayern	Germany	91315
844	GSK Investigational Site	Landsberg	Bayern	Germany	86899
845	GSK Investigational Site	Muenchen	Bayern	Germany	80335
846	GSK Investigational Site	Vilshofen	Bayern	Germany	94474
847	GSK Investigational Site	Weissenhorn	Bayern	Germany	89264
848	GSK Investigational Site	Cottbus	Brandenburg	Germany	03050
849	GSK Investigational Site	Potsdam	Brandenburg	Germany	14478
850	GSK Investigational Site	Ruedersdorf	Brandenburg	Germany	15562
851	GSK Investigational Site	Bensheim	Hessen	Germany	64625
852	GSK Investigational Site	Darmstadt	Hessen	Germany	64287
853	GSK Investigational Site	Kassel	Hessen	Germany	34121
854	GSK Investigational Site	Marburg	Hessen	Germany	35037
855	GSK Investigational Site	Goettingen	Niedersachsen	Germany	37081
856	GSK Investigational Site	Hannover	Niedersachsen	Germany	30159
857	GSK Investigational Site	Papenburg	Niedersachsen	Germany	26871
858	GSK Investigational Site	Stuhr	Niedersachsen	Germany	28816
859	GSK Investigational Site	Wardenburg	Niedersachsen	Germany	26203
860	GSK Investigational Site	Bergisch Gladbach	Nordrhein-Westfalen	Germany	51429
861	GSK Investigational Site	Bochum	Nordrhein-Westfalen	Germany	44787
862	GSK Investigational Site	Bonn	Nordrhein-Westfalen	Germany	53119
863	GSK Investigational Site	Bonn	Nordrhein-Westfalen	Germany	53123
864	GSK Investigational Site	Dortmund	Nordrhein-Westfalen	Germany	44263
865	GSK Investigational Site	Dueren	Nordrhein-Westfalen	Germany	52349
866	GSK Investigational Site	Essen	Nordrhein-Westfalen	Germany	45136
867	GSK Investigational Site	Essen	Nordrhein-Westfalen	Germany	45355
868	GSK Investigational Site	Gelsenkirchen	Nordrhein-Westfalen	Germany	45879
869	GSK Investigational Site	Hagen	Nordrhein-Westfalen	Germany	58089
870	GSK Investigational Site	Hagen	Nordrhein-Westfalen	Germany	58095
871	GSK Investigational Site	Harsewinkel	Nordrhein-Westfalen	Germany	33428
872	GSK Investigational Site	Koeln	Nordrhein-Westfalen	Germany	51069
873	GSK Investigational Site	Neuss	Nordrhein-Westfalen	Germany	41462
874	GSK Investigational Site	Solingen	Nordrhein-Westfalen	Germany	42651
875	GSK Investigational Site	Foehren	Rheinland-Pfalz	Germany	54343
876	GSK Investigational Site	Ingelheim	Rheinland-Pfalz	Germany	55218
877	GSK Investigational Site	Mainz	Rheinland-Pfalz	Germany	55116
878	GSK Investigational Site	Neuwied	Rheinland-Pfalz	Germany	56564
879	GSK Investigational Site	Rhaunen	Rheinland-Pfalz	Germany	55624
880	GSK Investigational Site	Magdeburg	Sachsen-Anhalt	Germany	39104
881	GSK Investigational Site	Zerbst	Sachsen-Anhalt	Germany	39261
882	GSK Investigational Site	Dresden	Sachsen	Germany	01067
883	GSK Investigational Site	Dresden	Sachsen	Germany	01307
884	GSK Investigational Site	Goerlitz	Sachsen	Germany	02826
885	GSK Investigational Site	Leipzg	Sachsen	Germany	04109
886	GSK Investigational Site	Leipzig	Sachsen	Germany	04103
887	GSK Investigational Site	Leipzig	Sachsen	Germany	04157
888	GSK Investigational Site	Leipzig	Sachsen	Germany	04275
889	GSK Investigational Site	Leipzig	Sachsen	Germany	04357
890	GSK Investigational Site	Riesa	Sachsen	Germany	01587
891	GSK Investigational Site	Reinfeld	Schleswig-Holstein	Germany	23858
892	GSK Investigational Site	Schleswig	Schleswig-Holstein	Germany	24837
893	GSK Investigational Site	Jena	Thueringen	Germany	07740
894	GSK Investigational Site	Berlin		Germany	10717
895	GSK Investigational Site	Berlin		Germany	10787
896	GSK Investigational Site	Berlin		Germany	10789
897	GSK Investigational Site	Berlin		Germany	10969
898	GSK Investigational Site	Berlin		Germany	12043
899	GSK Investigational Site	Berlin		Germany	12099
900	GSK Investigational Site	Berlin		Germany	12165
901	GSK Investigational Site	Berlin		Germany	12203
902	GSK Investigational Site	Berlin		Germany	12627
903	GSK Investigational Site	Berlin		Germany	12687
904	GSK Investigational Site	Berlin		Germany	13086
905	GSK Investigational Site	Berlin		Germany	13125
906	GSK Investigational Site	Berlin		Germany	13156
907	GSK Investigational Site	Berlin		Germany	13507
908	GSK Investigational Site	Hamburg		Germany	22291
909	GSK Investigational Site	Hamburg		Germany	22763
910	GSK Investigational Site	München		Germany	81677
911	GSK Investigational Site	Athens		Greece	11527
912	GSK Investigational Site	Athens		Greece	15126
913	GSK Investigational Site	Thessaloniki		Greece	57010
914	GSK Investigational Site	Balassagyarmat		Hungary	2660
915	GSK Investigational Site	Budapest		Hungary	1036
916	GSK Investigational Site	Budapest		Hungary	1101
917	GSK Investigational Site	Budapest		Hungary	1117
918	GSK Investigational Site	Budapest		Hungary	1122
919	GSK Investigational Site	Budapest		Hungary	1125
920	GSK Investigational Site	Budapest		Hungary	1134
921	GSK Investigational Site	Budapest		Hungary	1191
922	GSK Investigational Site	Budapest		Hungary	1204
923	GSK Investigational Site	Debrecen		Hungary	4026
924	GSK Investigational Site	Debrecen		Hungary	4031
925	GSK Investigational Site	Gyula		Hungary	5703
926	GSK Investigational Site	Kaposvár		Hungary	7400
927	GSK Investigational Site	Komarom		Hungary	2900
928	GSK Investigational Site	Komló		Hungary	7300
929	GSK Investigational Site	Mosonmagyaróvár		Hungary	9200
930	GSK Investigational Site	Nagykanizsa		Hungary	8800
931	GSK Investigational Site	Nyiregyhaza		Hungary	4400
932	GSK Investigational Site	Pécs		Hungary	7635
933	GSK Investigational Site	Sopron		Hungary	9400
934	GSK Investigational Site	Szigetszentmiklos		Hungary	2310
935	GSK Investigational Site	Szikszó		Hungary	H-3800
936	GSK Investigational Site	Szombathely		Hungary	9700
937	GSK Investigational Site	Tatabanya		Hungary	2800
938	GSK Investigational Site	Vasarosnameny		Hungary	4800
939	GSK Investigational Site	Zalaegerszeg		Hungary	8900
940	GSK Investigational Site	Ahmedabad		India	380007
941	GSK Investigational Site	Ahmedabad		India	380052
942	GSK Investigational Site	Alappuzha		India	688524
943	GSK Investigational Site	Angamaly		India	683 572
944	GSK Investigational Site	Aurangabad		India	431001
945	GSK Investigational Site	Bangalore		India	560 010
946	GSK Investigational Site	Bangalore		India	560 054
947	GSK Investigational Site	Bangalore		India	560034
948	GSK Investigational Site	Bangalore		India	560076
949	GSK Investigational Site	Chennai		India	600034
950	GSK Investigational Site	Chennai		India	600100
951	GSK Investigational Site	Guntur		India	522001
952	GSK Investigational Site	Hyderabad		India	500004
953	GSK Investigational Site	Hyderabad		India	500035
954	GSK Investigational Site	Hyderabad		India	500038
955	GSK Investigational Site	Jaipur		India	302006
956	GSK Investigational Site	Jaipur		India	302022
957	GSK Investigational Site	Lucknow		India	226018
958	GSK Investigational Site	Mysore		India	570002
959	GSK Investigational Site	Mysore		India	570004
960	GSK Investigational Site	Nagpur		India	440012
961	GSK Investigational Site	Nagpur		India	440019
962	GSK Investigational Site	Nashik		India	422007
963	GSK Investigational Site	Nasik		India	422005
964	GSK Investigational Site	Pune		India	411014
965	GSK Investigational Site	Pune		India	411015
966	GSK Investigational Site	Trisshur		India	680 002
967	GSK Investigational Site	Trivandrum		India	695004
968	GSK Investigational Site	Varanasi		India	221001
969	GSK Investigational Site	Varanasi		India	221005
970	GSK Investigational Site	Vijayawada		India	520002
971	GSK Investigational Site	Banda Aceh		Indonesia	23126
972	GSK Investigational Site	Banjarmasin		Indonesia	70233
973	GSK Investigational Site	Bukittinggi		Indonesia	26117
974	GSK Investigational Site	Denpasar		Indonesia	80114
975	GSK Investigational Site	Depok Timur		Indonesia	16411
976	GSK Investigational Site	Jakarta		Indonesia	12430
977	GSK Investigational Site	Jakarta		Indonesia	13230
978	GSK Investigational Site	Jakarta		Indonesia	13630
979	GSK Investigational Site	Lampung Selatan		Indonesia	35373
980	GSK Investigational Site	Makassar		Indonesia	90245
981	GSK Investigational Site	Malang		Indonesia	65100
982	GSK Investigational Site	Medan		Indonesia	20111
983	GSK Investigational Site	Medan		Indonesia	20154
984	GSK Investigational Site	Padang		Indonesia	25127
985	GSK Investigational Site	Palembang		Indonesia	30126
986	GSK Investigational Site	Pekanbaru		Indonesia	28133
987	GSK Investigational Site	Pontianak		Indonesia	78122
988	GSK Investigational Site	Pringsewu		Indonesia	35373
989	GSK Investigational Site	Semarang		Indonesia	50242
990	GSK Investigational Site	Surabaya		Indonesia	60286
991	GSK Investigational Site	Surakarta		Indonesia	57126
992	GSK Investigational Site	Yogyakarta		Indonesia	55283
993	GSK Investigational Site	Afula		Israel	18101
994	GSK Investigational Site	Ashkelon		Israel	78306
995	GSK Investigational Site	Beer-Sheba		Israel	84101
996	GSK Investigational Site	Hadera		Israel	PO Box 169
997	GSK Investigational Site	Haifa		Israel	31096
998	GSK Investigational Site	Haifa		Israel	34362
999	GSK Investigational Site	Holon		Israel	68125
1000	GSK Investigational Site	Jerusalem		Israel	91120
1001	GSK Investigational Site	Kfar Saba		Israel	44281
1002	GSK Investigational Site	Rehovot		Israel	76100
1003	GSK Investigational Site	Tel Aviv		Israel	64239
1004	GSK Investigational Site	Tel Hashomer		Israel	52621
1005	GSK Investigational Site	Pordenone	Friuli-Venezia-Giulia	Italy	33170
1006	GSK Investigational Site	Aichi		Japan	454-8502
1007	GSK Investigational Site	Aichi		Japan	457-8510
1008	GSK Investigational Site	Aichi		Japan	457-8511
1009	GSK Investigational Site	Fukuoka		Japan	832-0059
1010	GSK Investigational Site	Gifu		Japan	500-8717
1011	GSK Investigational Site	Hokkaido		Japan	053-8506
1012	GSK Investigational Site	Hokkaido		Japan	060-0033
1013	GSK Investigational Site	Hokkaido		Japan	070-8644
1014	GSK Investigational Site	Hyogo		Japan	650-0047
1015	GSK Investigational Site	Ibaraki		Japan	319-1113
1016	GSK Investigational Site	Kagawa		Japan	762-0031
1017	GSK Investigational Site	Kodaira		Japan	187-0002
1018	GSK Investigational Site	Kumamoto		Japan	861-1196
1019	GSK Investigational Site	Kyoto		Japan	607-8062
1020	GSK Investigational Site	Oita		Japan	876-0047
1021	GSK Investigational Site	Osaka		Japan	530-0001
1022	GSK Investigational Site	Osaka		Japan	558-8558
1023	GSK Investigational Site	Osaka		Japan	591-8555
1024	GSK Investigational Site	Shimane		Japan	690-8509
1025	GSK Investigational Site	Shimane		Japan	690-8556
1026	GSK Investigational Site	Tokyo		Japan	103-0027
1027	GSK Investigational Site	Tokyo		Japan	103-0028
1028	GSK Investigational Site	Tokyo		Japan	194-0023
1029	GSK Investigational Site	Bucheon-Si, Gyeonggi-Do		Korea, Republic of	420-021
1030	GSK Investigational Site	Bucheon		Korea, Republic of	420-717
1031	GSK Investigational Site	Busan		Korea, Republic of	602-715
1032	GSK Investigational Site	Cheonan		Korea, Republic of	330-721
1033	GSK Investigational Site	Chonju-si		Korea, Republic of	561-712
1034	GSK Investigational Site	Daegu		Korea, Republic of	705-717
1035	GSK Investigational Site	Daejeon		Korea, Republic of	301-721
1036	GSK Investigational Site	Daejeon		Korea, Republic of	301-723
1037	GSK Investigational Site	Goyang-si		Korea, Republic of	411706
1038	GSK Investigational Site	Guri-si		Korea, Republic of	471-701
1039	GSK Investigational Site	Gwangju		Korea, Republic of	501-757
1040	GSK Investigational Site	Gyeonggi-do		Korea, Republic of	410-719
1041	GSK Investigational Site	Incheon		Korea, Republic of	400-711
1042	GSK Investigational Site	Incheon		Korea, Republic of	403-720
1043	GSK Investigational Site	Kangwon		Korea, Republic of	200-722
1044	GSK Investigational Site	Seongnam		Korea, Republic of	463-712
1045	GSK Investigational Site	Seoul		Korea, Republic of	100-030
1046	GSK Investigational Site	Seoul		Korea, Republic of	110-746
1047	GSK Investigational Site	Seoul		Korea, Republic of	130-709
1048	GSK Investigational Site	Seoul		Korea, Republic of	130-872
1049	GSK Investigational Site	Seoul		Korea, Republic of	133--792
1050	GSK Investigational Site	Seoul		Korea, Republic of	135-720
1051	GSK Investigational Site	Seoul		Korea, Republic of	136-705
1052	GSK Investigational Site	Seoul		Korea, Republic of	139-707
1053	GSK Investigational Site	Seoul		Korea, Republic of	139-711
1054	GSK Investigational Site	Seoul		Korea, Republic of	140-887
1055	GSK Investigational Site	Seoul		Korea, Republic of	150-713
1056	GSK Investigational Site	Seoul		Korea, Republic of	152-703
1057	GSK Investigational Site	Seoul		Korea, Republic of	158-710
1058	GSK Investigational Site	Seoul		Korea, Republic of	380-704
1059	GSK Investigational Site	Seoul		Korea, Republic of
1060	GSK Investigational Site	Suwon, Gyeonggi-do		Korea, Republic of	442-723
1061	GSK Investigational Site	Uijeongbu, Gyeonggi-do		Korea, Republic of	480-717
1062	GSK Investigational Site	Ulsan		Korea, Republic of	682-714
1063	GSK Investigational Site	Wonju-si, Kanwon-do		Korea, Republic of	220-701
1064	GSK Investigational Site	Balvi		Latvia	LV - 4501
1065	GSK Investigational Site	Daugavpils		Latvia	LA-5403
1066	GSK Investigational Site	Daugavpils		Latvia	LV5410
1067	GSK Investigational Site	Jekabpils		Latvia	LV 5201
1068	GSK Investigational Site	Jelgava		Latvia	LV - 3001
1069	GSK Investigational Site	Jurmala		Latvia	LV-2010
1070	GSK Investigational Site	Kraslava		Latvia	LV - 5601
1071	GSK Investigational Site	Kuldiga		Latvia	LV - 3301
1072	GSK Investigational Site	Liepaja		Latvia	LV 3414
1073	GSK Investigational Site	Ogre		Latvia	LV - 5001
1074	GSK Investigational Site	Riga		Latvia	LV 1002
1075	GSK Investigational Site	Riga		Latvia	LV 1003
1076	GSK Investigational Site	Riga		Latvia	LV-1010
1077	GSK Investigational Site	Riga		Latvia	LV1001
1078	GSK Investigational Site	Riga		Latvia	LV1038
1079	GSK Investigational Site	Talsi		Latvia	LV - 3201
1080	GSK Investigational Site	Tukums		Latvia	LV - 3101
1081	GSK Investigational Site	Valmiera		Latvia	LV-4201
1082	GSK Investigational Site	Ventspils		Latvia	LV3601
1083	GSK Investigational Site	Bitola		Macedonia, The Former Yugoslav Republic of	7000
1084	GSK Investigational Site	Gostivar		Macedonia, The Former Yugoslav Republic of	1230
1085	GSK Investigational Site	Ohrid		Macedonia, The Former Yugoslav Republic of	6000
1086	GSK Investigational Site	Prilep		Macedonia, The Former Yugoslav Republic of	7500
1087	GSK Investigational Site	Shtip		Macedonia, The Former Yugoslav Republic of	2000
1088	GSK Investigational Site	Skopje		Macedonia, The Former Yugoslav Republic of	1000
1089	GSK Investigational Site	Strumica		Macedonia, The Former Yugoslav Republic of	2400
1090	GSK Investigational Site	Veles		Macedonia, The Former Yugoslav Republic of	1400
1091	GSK Investigational Site	Johor Bahru		Malaysia	80100
1092	GSK Investigational Site	Kuala Lumpur		Malaysia	50590
1093	GSK Investigational Site	Kuala Pilah		Malaysia	72000
1094	GSK Investigational Site	Kuching		Malaysia	93586
1095	GSK Investigational Site	Selangor		Malaysia	68100
1096	GSK Investigational Site	Sibu		Malaysia	96000
1097	GSK Investigational Site	Sungai Petani, Kedah		Malaysia	08000
1098	GSK Investigational Site	Taiping Perak		Malaysia	34000
1099	GSK Investigational Site	Cuautitlan Izcalli	Estado De México	Mexico	54769
1100	GSK Investigational Site	Guadalajara	Jalisco	Mexico	44500
1101	GSK Investigational Site	Zapopan	Jalisco	Mexico	45040
1102	GSK Investigational Site	Morelia	Michoacán	Mexico	C.P. 58249
1103	GSK Investigational Site	Cuernavaca	Morelos	Mexico	62350
1104	GSK Investigational Site	Monterrey	Nuevo León	Mexico	64460
1105	GSK Investigational Site	Monterrey	Nuevo León	Mexico	64710
1106	GSK Investigational Site	Hermosillo	Sonora	Mexico	83000
1107	GSK Investigational Site	Aguascalientes		Mexico	20127
1108	GSK Investigational Site	Chihuahua		Mexico	31203
1109	GSK Investigational Site	Chihuahua		Mexico	31238
1110	GSK Investigational Site	Guadalajara		Mexico	44670
1111	GSK Investigational Site	Hidalgo		Mexico	42070
1112	GSK Investigational Site	Merida		Mexico	97000
1113	GSK Investigational Site	Mexico D.F		Mexico	6700
1114	GSK Investigational Site	Monterrey		Mexico	64060
1115	GSK Investigational Site	México DF		Mexico	14050
1116	GSK Investigational Site	San luis Potosí		Mexico	78090
1117	GSK Investigational Site	Alkmaar		Netherlands	1815 JD
1118	GSK Investigational Site	Almelo		Netherlands	7609 PP
1119	GSK Investigational Site	Ede Gld		Netherlands	6717RP
1120	GSK Investigational Site	Helmond		Netherlands	5707 HA
1121	GSK Investigational Site	Zutphen		Netherlands	7207 AE
1122	GSK Investigational Site	Alabang, Muntinlupa City		Philippines	1780
1123	GSK Investigational Site	Caloocan		Philippines	1400
1124	GSK Investigational Site	Cavite		Philippines	4114
1125	GSK Investigational Site	Cebu City		Philippines	6000
1126	GSK Investigational Site	Dasmariñas, Cavite		Philippines	4114
1127	GSK Investigational Site	Davao		Philippines	8000
1128	GSK Investigational Site	Iloilo City		Philippines	5000
1129	GSK Investigational Site	Iloilo		Philippines	5000
1130	GSK Investigational Site	Jaro, Iloilo City		Philippines	5000
1131	GSK Investigational Site	Los Banos		Philippines	4030
1132	GSK Investigational Site	Manila		Philippines	1000
1133	GSK Investigational Site	Manila		Philippines	1012
1134	GSK Investigational Site	Marilao, Bulacan		Philippines	3019
1135	GSK Investigational Site	Pasay		Philippines	1300
1136	GSK Investigational Site	Pasig		Philippines	1605
1137	GSK Investigational Site	Quezon City		Philippines	1100
1138	GSK Investigational Site	Quezon City		Philippines	1102
1139	GSK Investigational Site	Quezon City		Philippines	1108
1140	GSK Investigational Site	Quezon City		Philippines	1109
1141	GSK Investigational Site	Quezon		Philippines	1104
1142	GSK Investigational Site	San Fernando, Pampanga		Philippines	2000
1143	GSK Investigational Site	Bialystok		Poland	15-003
1144	GSK Investigational Site	Bialystok		Poland	15-044
1145	GSK Investigational Site	Bielsko-Biala		Poland	43-300
1146	GSK Investigational Site	Bielsko-Biala		Poland	43-316
1147	GSK Investigational Site	Bienkowka		Poland	34-212
1148	GSK Investigational Site	Bydgoszcz		Poland	85-681
1149	GSK Investigational Site	Bydgoszcz		Poland	85-863
1150	GSK Investigational Site	Chelmza		Poland	87-140
1151	GSK Investigational Site	Chodziez		Poland	64-800
1152	GSK Investigational Site	Chorzow		Poland	41-500
1153	GSK Investigational Site	Choszczno		Poland	73-200
1154	GSK Investigational Site	Czestochowa		Poland	42-200
1155	GSK Investigational Site	Dabrowa Gornicza		Poland	41-300
1156	GSK Investigational Site	Dzialdowo		Poland	13-200
1157	GSK Investigational Site	Elblag		Poland	82-300
1158	GSK Investigational Site	Gdansk		Poland	80-286
1159	GSK Investigational Site	Gdansk		Poland	80-405
1160	GSK Investigational Site	Gdansk		Poland	80-433
1161	GSK Investigational Site	Gdynia		Poland	81-384
1162	GSK Investigational Site	Gorzow Wielkopolski		Poland	66-400
1163	GSK Investigational Site	Grudziadz		Poland	86-300
1164	GSK Investigational Site	Ilawa		Poland	14-200
1165	GSK Investigational Site	Inowroclaw		Poland	88-100
1166	GSK Investigational Site	Izabelin		Poland	05-080
1167	GSK Investigational Site	Jelenia Gora		Poland	58-506
1168	GSK Investigational Site	Karpacz		Poland	58-540
1169	GSK Investigational Site	Katowice		Poland	40-040
1170	GSK Investigational Site	Katowice		Poland	40-954
1171	GSK Investigational Site	Kielce		Poland	25-030
1172	GSK Investigational Site	Kielce		Poland	25-365
1173	GSK Investigational Site	Kielce		Poland	25-734
1174	GSK Investigational Site	Krakow		Poland	31-024
1175	GSK Investigational Site	Krakow		Poland	31-455
1176	GSK Investigational Site	Krakow		Poland	31-530
1177	GSK Investigational Site	Krakow		Poland	31-567
1178	GSK Investigational Site	Krakow		Poland	31-637
1179	GSK Investigational Site	Krakow		Poland	31-913
1180	GSK Investigational Site	Krotoszyn		Poland	63-700
1181	GSK Investigational Site	Ksawerow		Poland	95-054
1182	GSK Investigational Site	Kutno		Poland	99-300
1183	GSK Investigational Site	Libiaz		Poland	32-590
1184	GSK Investigational Site	Lodz		Poland	90-153
1185	GSK Investigational Site	Lodz		Poland	90-203
1186	GSK Investigational Site	Lodz		Poland	90-302
1187	GSK Investigational Site	Lodz		Poland	90-430
1188	GSK Investigational Site	Lodz		Poland	91-849
1189	GSK Investigational Site	Lodz		Poland	92-107
1190	GSK Investigational Site	Lodz		Poland	92-215
1191	GSK Investigational Site	Lodz		Poland	93-113
1192	GSK Investigational Site	Lodz		Poland	93-329
1193	GSK Investigational Site	Lodz		Poland	94-050
1194	GSK Investigational Site	Lublin		Poland	20-093
1195	GSK Investigational Site	Lublin		Poland	20-552
1196	GSK Investigational Site	Lublin		Poland	20-718
1197	GSK Investigational Site	Olawa		Poland	55-200
1198	GSK Investigational Site	Olsztyn		Poland	10-357
1199	GSK Investigational Site	Ostrow Wilekopolski		Poland	63-400
1200	GSK Investigational Site	Ostrowiec Swietokrzyski		Poland	27-400
1201	GSK Investigational Site	Piaseczno		Poland	05-500
1202	GSK Investigational Site	Pila		Poland	64-920
1203	GSK Investigational Site	Plock		Poland	09-402
1204	GSK Investigational Site	Police		Poland	72-010
1205	GSK Investigational Site	Poznan		Poland	60-214
1206	GSK Investigational Site	Poznan		Poland	60-569
1207	GSK Investigational Site	Poznan		Poland	60-773
1208	GSK Investigational Site	Poznan		Poland	60-823
1209	GSK Investigational Site	Ruda Slaska		Poland	41-709
1210	GSK Investigational Site	Rudka		Poland	05-320
1211	GSK Investigational Site	Rzeszow		Poland	35-301
1212	GSK Investigational Site	Skarzysko-Kamienna		Poland	26-110
1213	GSK Investigational Site	Skierniewice		Poland	96-100
1214	GSK Investigational Site	Slupsk		Poland	76-200
1215	GSK Investigational Site	Sopot		Poland	81- 717
1216	GSK Investigational Site	Swidnik		Poland	21-040
1217	GSK Investigational Site	Szczecin		Poland	70-111
1218	GSK Investigational Site	Szczecin		Poland	71-124
1219	GSK Investigational Site	Tarnow		Poland	33-100
1220	GSK Investigational Site	Tczew		Poland	83-110
1221	GSK Investigational Site	Torun		Poland	87100
1222	GSK Investigational Site	Warszawa		Poland	01-138
1223	GSK Investigational Site	Warszawa		Poland	01-157
1224	GSK Investigational Site	Warszawa		Poland	01-192
1225	GSK Investigational Site	Warszawa		Poland	01-868
1226	GSK Investigational Site	Wloclawek		Poland	87-800
1227	GSK Investigational Site	Wloszczowa		Poland	29-100
1228	GSK Investigational Site	Wodzislaw Slaski		Poland	44-300
1229	GSK Investigational Site	Wroclaw		Poland	50-044
1230	GSK Investigational Site	Wroclaw		Poland	50-088
1231	GSK Investigational Site	Wroclaw		Poland	53-301
1232	GSK Investigational Site	Wroclaw		Poland	53-439
1233	GSK Investigational Site	Wroclaw		Poland	54-239
1234	GSK Investigational Site	Zabrze		Poland	41-800
1235	GSK Investigational Site	Zabrze		Poland	41-807
1236	GSK Investigational Site	Zgierz		Poland	95-100
1237	GSK Investigational Site	Łęczyca		Poland	99-100
1238	GSK Investigational Site	Arad		Romania	310013
1239	GSK Investigational Site	Bacau		Romania	600252
1240	GSK Investigational Site	Bragadiru		Romania	077025
1241	GSK Investigational Site	Brasov		Romania	500086
1242	GSK Investigational Site	Brasov		Romania	500283
1243	GSK Investigational Site	Bucarest		Romania	050159
1244	GSK Investigational Site	Bucharest		Romania	011794
1245	GSK Investigational Site	Bucharest		Romania	020125
1246	GSK Investigational Site	Bucharest		Romania	030303
1247	GSK Investigational Site	Bucharest		Romania	050159
1248	GSK Investigational Site	Bucuresti		Romania	011025
1249	GSK Investigational Site	Bucuresti		Romania	012384
1250	GSK Investigational Site	Bucuresti		Romania	014461
1251	GSK Investigational Site	Bucuresti		Romania	020475
1252	GSK Investigational Site	Bucuresti		Romania	021659
1253	GSK Investigational Site	Bucuresti		Romania	022328
1254	GSK Investigational Site	Bucuresti		Romania	030303
1255	GSK Investigational Site	Bucuresti		Romania	040206
1256	GSK Investigational Site	Bucuresti		Romania	050159
1257	GSK Investigational Site	Bucuresti		Romania	050554
1258	GSK Investigational Site	Bucuresti		Romania	050722
1259	GSK Investigational Site	Bucuresti		Romania	10825
1260	GSK Investigational Site	Campulung Muscel		Romania	115100
1261	GSK Investigational Site	Cluj-Napoca		Romania	400352
1262	GSK Investigational Site	Cluj-Napoca		Romania	400371
1263	GSK Investigational Site	Codlea		Romania	505100
1264	GSK Investigational Site	Constanta		Romania	900002
1265	GSK Investigational Site	Constanta		Romania	900004
1266	GSK Investigational Site	Deva		Romania	330084
1267	GSK Investigational Site	Iasi		Romania	700141
1268	GSK Investigational Site	Iasi		Romania	700381
1269	GSK Investigational Site	Iasi		Romania	700503
1270	GSK Investigational Site	Iasi		Romania	700656
1271	GSK Investigational Site	Pitesti		Romania	110084
1272	GSK Investigational Site	Pitesti		Romania	110283
1273	GSK Investigational Site	Ploiesti		Romania	100184
1274	GSK Investigational Site	Ramnicu Valcea		Romania	240564
1275	GSK Investigational Site	Suceava		Romania	720284
1276	GSK Investigational Site	Targu-Mures		Romania	540142
1277	GSK Investigational Site	Timisoara		Romania	300310
1278	GSK Investigational Site	Timisoara		Romania	300736
1279	GSK Investigational Site	Arkhangelsk		Russian Federation	163001
1280	GSK Investigational Site	Arkhangelsk		Russian Federation	163061
1281	GSK Investigational Site	Barnaul		Russian Federation	656024
1282	GSK Investigational Site	Barnaul		Russian Federation	656038
1283	GSK Investigational Site	Chelyabinsk		Russian Federation	454021
1284	GSK Investigational Site	Chelyabinsk		Russian Federation	454047
1285	GSK Investigational Site	Chelyabinsk		Russian Federation	454091
1286	GSK Investigational Site	Ekaterinburg		Russian Federation	620109
1287	GSK Investigational Site	Ekaterinburg		Russian Federation	620137
1288	GSK Investigational Site	Ekaterinburg		Russian Federation	620149
1289	GSK Investigational Site	Gatchina		Russian Federation	188300
1290	GSK Investigational Site	Ivanovo		Russian Federation	153462
1291	GSK Investigational Site	Izhevsk		Russian Federation	426063
1292	GSK Investigational Site	Kaliningrad		Russian Federation	236016
1293	GSK Investigational Site	Kazan		Russian Federation	420012
1294	GSK Investigational Site	Kemerovo		Russian Federation	650000
1295	GSK Investigational Site	Kemerovo		Russian Federation	650002
1296	GSK Investigational Site	Kirov		Russian Federation	610027
1297	GSK Investigational Site	Krasnoyarsk		Russian Federation	660022
1298	GSK Investigational Site	Kursk		Russian Federation	305035
1299	GSK Investigational Site	Moscow		Russian Federation	105066
1300	GSK Investigational Site	Moscow		Russian Federation	107392
1301	GSK Investigational Site	Moscow		Russian Federation	109263
1302	GSK Investigational Site	Moscow		Russian Federation	111111
1303	GSK Investigational Site	Moscow		Russian Federation	111539
1304	GSK Investigational Site	Moscow		Russian Federation	115 280
1305	GSK Investigational Site	Moscow		Russian Federation	115093
1306	GSK Investigational Site	Moscow		Russian Federation	115432
1307	GSK Investigational Site	Moscow		Russian Federation	115478
1308	GSK Investigational Site	Moscow		Russian Federation	115516
1309	GSK Investigational Site	Moscow		Russian Federation	115682
1310	GSK Investigational Site	Moscow		Russian Federation	117292
1311	GSK Investigational Site	Moscow		Russian Federation	117593
1312	GSK Investigational Site	Moscow		Russian Federation	117630
1313	GSK Investigational Site	Moscow		Russian Federation	117997
1314	GSK Investigational Site	Moscow		Russian Federation	119002
1315	GSK Investigational Site	Moscow		Russian Federation	119048
1316	GSK Investigational Site	Moscow		Russian Federation	119049
1317	GSK Investigational Site	Moscow		Russian Federation	119121
1318	GSK Investigational Site	Moscow		Russian Federation	119229
1319	GSK Investigational Site	Moscow		Russian Federation	119620
1320	GSK Investigational Site	Moscow		Russian Federation	119991
1321	GSK Investigational Site	Moscow		Russian Federation	121 309
1322	GSK Investigational Site	Moscow		Russian Federation	121374
1323	GSK Investigational Site	Moscow		Russian Federation	123060
1324	GSK Investigational Site	Moscow		Russian Federation	123182
1325	GSK Investigational Site	Moscow		Russian Federation	125205
1326	GSK Investigational Site	Moscow		Russian Federation	125299
1327	GSK Investigational Site	Moscow		Russian Federation	127018
1328	GSK Investigational Site	Moscow		Russian Federation	129090
1329	GSK Investigational Site	Moscow		Russian Federation	129301
1330	GSK Investigational Site	Nizhniy Novgorod		Russian Federation	603035
1331	GSK Investigational Site	Novosibirsk		Russian Federation	630008
1332	GSK Investigational Site	Novosibirsk		Russian Federation	630051
1333	GSK Investigational Site	Novosibirsk		Russian Federation	630075
1334	GSK Investigational Site	Novosibirsk		Russian Federation	630087
1335	GSK Investigational Site	Novosibirsk		Russian Federation	630091
1336	GSK Investigational Site	Novosibirsk		Russian Federation	630099
1337	GSK Investigational Site	Novosibirsk		Russian Federation
1338	GSK Investigational Site	Orenburg		Russian Federation	460000
1339	GSK Investigational Site	Orenburg		Russian Federation	460018
1340	GSK Investigational Site	Perm		Russian Federation	614070
1341	GSK Investigational Site	Perm		Russian Federation	614097
1342	GSK Investigational Site	Perm		Russian Federation	614111
1343	GSK Investigational Site	Pskov		Russian Federation	180016
1344	GSK Investigational Site	Rostov-on-Don		Russian Federation	344022
1345	GSK Investigational Site	Ryazan		Russian Federation	390005
1346	GSK Investigational Site	Ryazan		Russian Federation	390026
1347	GSK Investigational Site	Ryazan		Russian Federation	390039
1348	GSK Investigational Site	Saint Petersburg		Russian Federation	192177
1349	GSK Investigational Site	Saint Petersburg		Russian Federation	194044
1350	GSK Investigational Site	Saint Petersburg		Russian Federation	195257
1351	GSK Investigational Site	Saint Petersburg		Russian Federation	196084
1352	GSK Investigational Site	Saint Petersburg		Russian Federation	197022
1353	GSK Investigational Site	Saint Petersburg		Russian Federation	198103
1354	GSK Investigational Site	Saint-Petersburg		Russian Federation	194354
1355	GSK Investigational Site	Saint-Petersburg		Russian Federation	195112
1356	GSK Investigational Site	Saint-Petersburg		Russian Federation	196084
1357	GSK Investigational Site	Saint-Petersburg		Russian Federation	196601
1358	GSK Investigational Site	Saint-Petersburg		Russian Federation	198260
1359	GSK Investigational Site	Saint-Petersburg		Russian Federation	198328
1360	GSK Investigational Site	Saratov		Russian Federation	410012
1361	GSK Investigational Site	Saratov		Russian Federation	410018
1362	GSK Investigational Site	Saratov		Russian Federation	410028
1363	GSK Investigational Site	Saratov		Russian Federation	410039
1364	GSK Investigational Site	Saratov		Russian Federation	410054
1365	GSK Investigational Site	Sestroretsk		Russian Federation	197706
1366	GSK Investigational Site	Smolensk		Russian Federation	214 019
1367	GSK Investigational Site	Smolensk		Russian Federation	214006
1368	GSK Investigational Site	St Petersburg		Russian Federation	192283
1369	GSK Investigational Site	St Petersburg		Russian Federation	194354
1370	GSK Investigational Site	St'Petersburg		Russian Federation	193312
1371	GSK Investigational Site	St-Petersburg		Russian Federation	193312
1372	GSK Investigational Site	St-Petersburg		Russian Federation	194017
1373	GSK Investigational Site	St-Petersburg		Russian Federation	199106
1374	GSK Investigational Site	St. Petersburg		Russian Federation	190103
1375	GSK Investigational Site	St. Petersburg		Russian Federation	191015
1376	GSK Investigational Site	St. Petersburg		Russian Federation	194356
1377	GSK Investigational Site	St. Petersburg		Russian Federation	197022
1378	GSK Investigational Site	St.Petersburg		Russian Federation	191025
1379	GSK Investigational Site	St.Petersburg		Russian Federation	197089
1380	GSK Investigational Site	St.Рetersburg		Russian Federation	198035
1381	GSK Investigational Site	Tomsk		Russian Federation	634 050
1382	GSK Investigational Site	Tomsk		Russian Federation	634012
1383	GSK Investigational Site	Tomsk		Russian Federation	634050
1384	GSK Investigational Site	Tomsk		Russian Federation	634063
1385	GSK Investigational Site	Tver		Russian Federation	170036
1386	GSK Investigational Site	Ufa		Russian Federation	450071
1387	GSK Investigational Site	Ulyanovsk		Russian Federation	432063
1388	GSK Investigational Site	Voronezh		Russian Federation	394018
1389	GSK Investigational Site	Voronezh		Russian Federation	394066
1390	GSK Investigational Site	Vsevolzhsk		Russian Federation	188640
1391	GSK Investigational Site	Yaroslavl		Russian Federation	150002
1392	GSK Investigational Site	Yaroslavl		Russian Federation	150003
1393	GSK Investigational Site	Yaroslavl		Russian Federation	150010
1394	GSK Investigational Site	Yaroslavl		Russian Federation	150023
1395	GSK Investigational Site	Yaroslavl		Russian Federation	150062
1396	GSK Investigational Site	Belgrade		Serbia	11000
1397	GSK Investigational Site	Belgrade		Serbia	11080
1398	GSK Investigational Site	Cacak		Serbia	32000
1399	GSK Investigational Site	Kragujevac		Serbia	34000
1400	GSK Investigational Site	Nis		Serbia	18000
1401	GSK Investigational Site	Sombor		Serbia	25000
1402	GSK Investigational Site	Sremska Kamenica		Serbia	21204
1403	GSK Investigational Site	Valjevo		Serbia	14000
1404	GSK Investigational Site	Bratislava		Slovakia	821 06
1405	GSK Investigational Site	Bratislava		Slovakia	841 04
1406	GSK Investigational Site	Bratislava		Slovakia	841 08
1407	GSK Investigational Site	Bratislava		Slovakia	851 01
1408	GSK Investigational Site	Kosice		Slovakia	040 01
1409	GSK Investigational Site	Kralovsky Chlmec		Slovakia	077 01
1410	GSK Investigational Site	Nove Zamky		Slovakia	940 01
1411	GSK Investigational Site	Presov		Slovakia	080 01
1412	GSK Investigational Site	Presov		Slovakia	081 81
1413	GSK Investigational Site	Spisska Nova Ves		Slovakia	052 01
1414	GSK Investigational Site	Sturovo		Slovakia	943 01
1415	GSK Investigational Site	Trnava		Slovakia	917 01
1416	GSK Investigational Site	Vrable		Slovakia	952 01
1417	GSK Investigational Site	Benoni	Gauteng	South Africa	1501
1418	GSK Investigational Site	Boksburg	Gauteng	South Africa	1459
1419	GSK Investigational Site	Meyerspark	Gauteng	South Africa	0184
1420	GSK Investigational Site	Morningside	Gauteng	South Africa	2057
1421	GSK Investigational Site	Pretoria	Gauteng	South Africa	0041
1422	GSK Investigational Site	Pretoria	Gauteng	South Africa	0084
1423	GSK Investigational Site	Pretoria	Gauteng	South Africa	0181
1424	GSK Investigational Site	Pretoria	Gauteng	South Africa	0183
1425	GSK Investigational Site	Thaba Tshwane	Gauteng	South Africa	0143
1426	GSK Investigational Site	Dundee	KwaZulu- Natal	South Africa	3000
1427	GSK Investigational Site	Middelburg	Mpumalanga	South Africa	1055
1428	GSK Investigational Site	Benoni		South Africa	1501
1429	GSK Investigational Site	Bloemfontein		South Africa	9301
1430	GSK Investigational Site	Cape Town		South Africa	7441
1431	GSK Investigational Site	Cape Town		South Africa	7500
1432	GSK Investigational Site	Cape Town		South Africa	7572
1433	GSK Investigational Site	Cape Town		South Africa	7700
1434	GSK Investigational Site	Cape Town		South Africa	8001
1435	GSK Investigational Site	CapeTown		South Africa	7764
1436	GSK Investigational Site	Durban		South Africa	4001
1437	GSK Investigational Site	Durban		South Africa	4071
1438	GSK Investigational Site	Gatesville		South Africa	7764
1439	GSK Investigational Site	Johannesburg		South Africa	1686
1440	GSK Investigational Site	Korsten		South Africa	6014
1441	GSK Investigational Site	Lynnwood Ridge		South Africa	0014
1442	GSK Investigational Site	Mowbray		South Africa	7700
1443	GSK Investigational Site	Paarl		South Africa	7646
1444	GSK Investigational Site	Panorama		South Africa	7500
1445	GSK Investigational Site	Potchefstroom		South Africa	2531
1446	GSK Investigational Site	Pretoria		South Africa	0002
1447	GSK Investigational Site	Pretoria		South Africa	0022
1448	GSK Investigational Site	Roodepoort		South Africa	1724
1449	GSK Investigational Site	Rooihuiskraal		South Africa	158
1450	GSK Investigational Site	Somerset West		South Africa	7130
1451	GSK Investigational Site	Thabazimbi		South Africa	0380
1452	GSK Investigational Site	Tygerberg		South Africa	7505
1453	GSK Investigational Site	Voorspoed		South Africa	9459
1454	GSK Investigational Site	Badalona		Spain	08916
1455	GSK Investigational Site	Barcelona		Spain	08022
1456	GSK Investigational Site	Barcelona		Spain	08025
1457	GSK Investigational Site	Barcelona		Spain	08036
1458	GSK Investigational Site	Barcelona		Spain	08041
1459	GSK Investigational Site	Benidorm		Spain	03501
1460	GSK Investigational Site	Canet De Mar - Barcelona		Spain	08360
1461	GSK Investigational Site	Galdakano		Spain	48960
1462	GSK Investigational Site	Illescas-Toledo		Spain	45200
1463	GSK Investigational Site	Jerez de la Frontera		Spain	11407
1464	GSK Investigational Site	L'Hospitalet de Llobregat		Spain	08907
1465	GSK Investigational Site	Madrid		Spain	28040
1466	GSK Investigational Site	Madrid		Spain	28046
1467	GSK Investigational Site	Mataró		Spain	08303
1468	GSK Investigational Site	Oviedo		Spain	33006
1469	GSK Investigational Site	Palma de Mallorca		Spain	07010
1470	GSK Investigational Site	Pamplona		Spain	31008
1471	GSK Investigational Site	Pozuelo De Alarcón/Madrid		Spain	28223
1472	GSK Investigational Site	Sabadell (Barcelona)		Spain	08208
1473	GSK Investigational Site	Sagunto/Valencia		Spain	46520
1474	GSK Investigational Site	Sant Boi de Llobregat		Spain	08830
1475	GSK Investigational Site	Santa Coloma de Gramenet		Spain	08921
1476	GSK Investigational Site	Santiago de Compostela		Spain	15706
1477	GSK Investigational Site	Torrelavega		Spain	39300
1478	GSK Investigational Site	Valencia		Spain	46017
1479	GSK Investigational Site	Vic (Barcelona)		Spain	08500
1480	GSK Investigational Site	Changhua		Taiwan	500
1481	GSK Investigational Site	Chia-Yi		Taiwan	613
1482	GSK Investigational Site	Kaohsiung Hsien		Taiwan	833
1483	GSK Investigational Site	Kaohsiung		Taiwan	807
1484	GSK Investigational Site	Keelung		Taiwan	20401
1485	GSK Investigational Site	LinKou		Taiwan	333
1486	GSK Investigational Site	Taichung		Taiwan	40201
1487	GSK Investigational Site	Taichung		Taiwan	404
1488	GSK Investigational Site	Taichung		Taiwan	40705
1489	GSK Investigational Site	Taichung		Taiwan	433
1490	GSK Investigational Site	Taichung		Taiwan	437
1491	GSK Investigational Site	Tainan		Taiwan	704
1492	GSK Investigational Site	Taipei		Taiwan	106
1493	GSK Investigational Site	Taipei		Taiwan	115
1494	GSK Investigational Site	Taipei		Taiwan	220
1495	GSK Investigational Site	Taipei		Taiwan	235
1496	GSK Investigational Site	Taipei		Taiwan
1497	GSK Investigational Site	Yung Kang City		Taiwan	71044
1498	GSK Investigational Site	Bangkok		Thailand	10220
1499	GSK Investigational Site	Bangkok		Thailand	10330
1500	GSK Investigational Site	Bangkok		Thailand	10400
1501	GSK Investigational Site	Bangkok		Thailand	10600
1502	GSK Investigational Site	Bangkok		Thailand	10700
1503	GSK Investigational Site	Chiangmai		Thailand	50200
1504	GSK Investigational Site	Chiangrai		Thailand	57000
1505	GSK Investigational Site	Khon Kaen		Thailand	40002
1506	GSK Investigational Site	Mae Rim, Chiang Mai		Thailand	50180
1507	GSK Investigational Site	Muang Phitsanulok		Thailand	53000
1508	GSK Investigational Site	Muang		Thailand	11000
1509	GSK Investigational Site	Nakhon Ratchasima		Thailand	30000
1510	GSK Investigational Site	Phitsanulok		Thailand	65000
1511	GSK Investigational Site	Songkla		Thailand	90110
1512	GSK Investigational Site	Ankara		Turkey	06280
1513	GSK Investigational Site	Ankara		Turkey	06500
1514	GSK Investigational Site	Ankara		Turkey	06510
1515	GSK Investigational Site	Ankara		Turkey	06590
1516	GSK Investigational Site	Ankara		Turkey	6030
1517	GSK Investigational Site	Bursa		Turkey	16059
1518	GSK Investigational Site	Istanbul		Turkey	34020
1519	GSK Investigational Site	İstanbul		Turkey	34098
1520	GSK Investigational Site	Istanbul		Turkey	34844
1521	GSK Investigational Site	Istanbul		Turkey	34899
1522	GSK Investigational Site	Istanbul		Turkey	61080
1523	GSK Investigational Site	Kocaeli		Turkey	41380
1524	GSK Investigational Site	Konya		Turkey	42080
1525	GSK Investigational Site	Samsun		Turkey	55139
1526	GSK Investigational Site	Alupka		Ukraine	98676
1527	GSK Investigational Site	Cherkassy		Ukraine	18009
1528	GSK Investigational Site	Chernihiv		Ukraine	14034
1529	GSK Investigational Site	Chernivtsi		Ukraine	58022
1530	GSK Investigational Site	Dnipropetrovsk		Ukraine	49005
1531	GSK Investigational Site	Dnipropetrovsk		Ukraine	49027
1532	GSK Investigational Site	Dnipropetrovsk		Ukraine	49064
1533	GSK Investigational Site	Dnipropetrovsk		Ukraine	49074
1534	GSK Investigational Site	Dnipropetrovsk		Ukraine	49102
1535	GSK Investigational Site	Donetsk		Ukraine	83003
1536	GSK Investigational Site	Donetsk		Ukraine	83045
1537	GSK Investigational Site	Donetsk		Ukraine	83059
1538	GSK Investigational Site	Donetsk		Ukraine	83114
1539	GSK Investigational Site	Ivano-Frankivsk		Ukraine	76005
1540	GSK Investigational Site	Ivano-Frankivsk		Ukraine	76008
1541	GSK Investigational Site	Ivano-Frankivsk		Ukraine	76018
1542	GSK Investigational Site	Kharkiv		Ukraine	61001
1543	GSK Investigational Site	Kharkiv		Ukraine	61002
1544	GSK Investigational Site	Kharkiv		Ukraine	61018
1545	GSK Investigational Site	Kharkiv		Ukraine	61022
1546	GSK Investigational Site	Kharkiv		Ukraine	61039
1547	GSK Investigational Site	Kharkiv		Ukraine	61046
1548	GSK Investigational Site	Kharkiv		Ukraine	61103
1549	GSK Investigational Site	Kharkiv		Ukraine	61124
1550	GSK Investigational Site	Kharkiv		Ukraine	61157
1551	GSK Investigational Site	Kherson		Ukraine	73000
1552	GSK Investigational Site	Kiev		Ukraine	02660
1553	GSK Investigational Site	Kiev		Ukraine	03680
1554	GSK Investigational Site	Kryvyi Rig		Ukraine	50096
1555	GSK Investigational Site	Kyiv		Ukraine	03038
1556	GSK Investigational Site	Kyiv		Ukraine	03049
1557	GSK Investigational Site	Kyiv		Ukraine	03179
1558	GSK Investigational Site	Kyiv		Ukraine	03680
1559	GSK Investigational Site	Kyiv		Ukraine	04114
1560	GSK Investigational Site	Kyiv		Ukraine	04201
1561	GSK Investigational Site	Kyiv		Ukraine	1680
1562	GSK Investigational Site	Kyiv		Ukraine	4050
1563	GSK Investigational Site	Kyiv		Ukraine	4107
1564	GSK Investigational Site	Lutsk		Ukraine	43024
1565	GSK Investigational Site	Lviv		Ukraine	79010
1566	GSK Investigational Site	Lviv		Ukraine	79015
1567	GSK Investigational Site	Mykolaiv		Ukraine	54003
1568	GSK Investigational Site	Odesa		Ukraine	65010
1569	GSK Investigational Site	Odesa		Ukraine	65114
1570	GSK Investigational Site	Odessa		Ukraine	65009
1571	GSK Investigational Site	Odessa		Ukraine	65025
1572	GSK Investigational Site	Poltava		Ukraine	36024
1573	GSK Investigational Site	Poltava		Ukraine	36028
1574	GSK Investigational Site	Poltava		Ukraine	36038
1575	GSK Investigational Site	Simferopol		Ukraine	95043
1576	GSK Investigational Site	Sumy		Ukraine	40022
1577	GSK Investigational Site	Sumy		Ukraine	40030
1578	GSK Investigational Site	Sympheropol		Ukraine	95017
1579	GSK Investigational Site	Ternopil		Ukraine	46002
1580	GSK Investigational Site	Uzhhorod		Ukraine	88000
1581	GSK Investigational Site	Uzhhorod		Ukraine	88009
1582	GSK Investigational Site	Uzhhorod		Ukraine	88017
1583	GSK Investigational Site	Vinnytsia		Ukraine	21018
1584	GSK Investigational Site	Vinnytsia		Ukraine	21029
1585	GSK Investigational Site	Vinnytsya		Ukraine	21001
1586	GSK Investigational Site	Yalta		Ukraine	98603
1587	GSK Investigational Site	Zaporizhia		Ukraine	69035
1588	GSK Investigational Site	Zaporizhzhia		Ukraine	69106
1589	GSK Investigational Site	Zaporizhzhia		Ukraine	69118
1590	GSK Investigational Site	Zaporizhzhia		Ukraine	69600
1591	GSK Investigational Site	Zaporizhzhya		Ukraine	69001
1592	GSK Investigational Site	Zhytomyr		Ukraine	10002
1593	GSK Investigational Site	Bedford	Bedfordshire	United Kingdom	MK404AW
1594	GSK Investigational Site	Bedford	Bedfordshire	United Kingdom	MK42 9DJ
1595	GSK Investigational Site	Peterborough	Cambridgeshire	United Kingdom	PE8 6PL
1596	GSK Investigational Site	Soham	Cambridgeshire	United Kingdom	CB7 5JD
1597	GSK Investigational Site	Chesterfield	Derbyshire	United Kingdom	S40 4AA
1598	GSK Investigational Site	Buckshaw Village, Chorley	Lancashire	United Kingdom	PR7 7NA
1599	GSK Investigational Site	Liverpool	Merseyside	United Kingdom	L9 7AL
1600	GSK Investigational Site	Waterloo, Liverpool	Merseyside	United Kingdom	L22 0LG
1601	GSK Investigational Site	Northwood	Middlesex	United Kingdom	HA6 2RN
1602	GSK Investigational Site	Bury St Edmunds	Suffolk	United Kingdom	IP30 9QU
1603	GSK Investigational Site	Bexhill-on-Sea		United Kingdom	TN40 1JJ
1604	GSK Investigational Site	Birmingham		United Kingdom	B9 5SS
1605	GSK Investigational Site	Brighton		United Kingdom	BN2 5BE
1606	GSK Investigational Site	Cardiff		United Kingdom	CF14 5GJ
1607	GSK Investigational Site	Chelmsford		United Kingdom	CM1 7ET
1608	GSK Investigational Site	Derby		United Kingdom	DE22 3NE
1609	GSK Investigational Site	Edgbaston, Birmingham		United Kingdom	B15 2SQ
1610	GSK Investigational Site	Edinburgh		United Kingdom	EH16 4SA
1611	GSK Investigational Site	Glasgow		United Kingdom	G20 0SP
1612	GSK Investigational Site	London		United Kingdom	EC1M 6BQ
1613	GSK Investigational Site	Manchester		United Kingdom	M15 6SX
1614	GSK Investigational Site	Milton Keynes		United Kingdom	MK6 5LD
1615	GSK Investigational Site	Reading		United Kingdom	RG2 0TG
1616	GSK Investigational Site	Sidcup, Kent		United Kingdom	DA14 6LT
1617	GSK Investigational Site	Tyne And Wear		United Kingdom	NE29 8NH
1618	GSK Investigational Site	Can Tho		Vietnam	90000
1619	GSK Investigational Site	Ha Noi		Vietnam	10000
1620	GSK Investigational Site	Ho Chi Minh		Vietnam	70000
1621	GSK Investigational Site	Hue		Vietnam	53000

Sponsors and Collaborators

• GlaxoSmithKline

Investigators

• Study Director: GSK Clinical Trials, GlaxoSmithKline

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Publications

None provided.

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT01313676
• Other Study ID Numbers: 113782
• First Posted: Mar 14, 2011
• Last Update Posted: Aug 6, 2018
• Last Verified: Aug 1, 2018

• Keywords provided by GlaxoSmithKline: COPD; Cardiovascular disease; Novel Dry Powder Inhaler; Survival
• Additional relevant MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Fluticasone; Xhance

Study Results

Participant Flow

Recruitment Details	This study was conducted at 1373 sites. The study employed an event-driven design and was to conclude when approximately 1000 reports of a primary outcome event of death were received. The study consisted of a 4-10 day run-in period, variable treatment period until the required number of events was achieved, and 1 week follow-up period.
Pre-assignment Detail	A total of 23,835 participants were screened, of whom 16,590 were randomized. Of the 16,590 participants randomized, 16,568 participants received a single dose of investigational product (IP) and were assigned to a treatment and included in the Safety Population.

Arm/Group Title	Placebo	Fluticasone Furoate 100 µg	Vilanterol 25 µg	Fluticasone Furoate/Vilanterol 100/25 µg
Arm/Group Description	Participants received placebo once daily (OD) in the morning from the dry powder inhaler (DPI) until the required number of events (death) was achieved. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.	Participants received Fluticasone Furoate (FF) 100 microgram (µg) inhalation powder OD in the morning from the DPI until the required number of events (death) was achieved. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.	Participants received Vilanterol (VI) 25 µg inhalation powder OD in the morning from the DPI until the required number of events (death) was achieved. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.	Participants received FF/VI 100/25 µg inhalation powder OD in the morning from the DPI until the required number of events (death) was achieved. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
Period Title: Overall Study
STARTED	4131	4157	4140	4140
COMPLETED	2881	3044	3052	3146
NOT COMPLETED	1250	1113	1088	994

Baseline Characteristics

Arm/Group Title	Placebo	Fluticasone Furoate 100 µg	Vilanterol 25 µg	Fluticasone Furoate/Vilanterol 100/25 µg	Total
Arm/Group Description	Participants received placebo once daily (OD) in the morning from the dry powder inhaler (DPI) until the required number of events (death) was achieved. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.	Participants received Fluticasone Furoate (FF) 100 microgram (µg) inhalation powder OD in the morning from the DPI until the required number of events (death) was achieved. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.	Participants received Vilanterol (VI) 25 µg inhalation powder OD in the morning from the DPI until the required number of events (death) was achieved. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.	Participants received FF/VI 100/25 µg inhalation powder OD in the morning from the DPI until the required number of events (death) was achieved. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.	Total of all reporting groups
Overall Participants	4131	4157	4140	4140	16568
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	65.2 (7.90)	65.0 (8.02)	65.2 (7.68)	65.3 (7.97)	65.2 (7.89)
Sex: Female, Male (Count of Participants)
Female	1050 25.4%	1098 26.4%	1071 25.9%	1019 24.6%	4238 25.6%
Male	3081 74.6%	3059 73.6%	3069 74.1%	3121 75.4%	12330 74.4%
Race/Ethnicity, Customized (Number) [Number]
African American /African Heritage	61 1.5%	62 1.5%	68 1.6%	69 1.7%	260 1.6%
American Indian or Alaskan Native	9 0.2%	5 0.1%	4 0.1%	9 0.2%	27 0.2%
Asian - Central /South Asian Heritage	64 1.5%	55 1.3%	62 1.5%	57 1.4%	238 1.4%
Asian - East Asian Heritage	192 4.6%	193 4.6%	195 4.7%	192 4.6%	772 4.7%
Asian - Japanese Heritage	34 0.8%	36 0.9%	37 0.9%	37 0.9%	144 0.9%
Asian - Mixed Race	1 0%	0 0%	0 0%	0 0%	1 0%
Asian - South East Asian Heritage	389 9.4%	399 9.6%	386 9.3%	394 9.5%	1568 9.5%
Native Hawaiian or Other Pacific Islander	1 0%	2 0%	0 0%	2 0%	5 0%
White - Arabic/North African Heritage	14 0.3%	13 0.3%	7 0.2%	12 0.3%	46 0.3%
White - Mixed Race	0 0%	0 0%	0 0%	1 0%	1 0%
White - White/Caucasian /European Heritage	3334 80.7%	3367 81%	3353 81%	3337 80.6%	13391 80.8%
Mixed Race	32 0.8%	25 0.6%	28 0.7%	30 0.7%	115 0.7%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Death (Both on and Off Treatment) Due to Any Cause, Time up to or on the Pre-determined Common End Date
Description	Death from any cause: which occurred from the day of starting IP until the Commone End Date (CED). Common End Date (CED) is the study end date that was pre determined where approximately 1000 deaths would have occurred in the Intent-toTreat Efficacy (ITT-E) Population. Only deaths which occurred on or before the CED were used for the primary analysis. Those who had not died by CED, but who were known to be alive on or after the CED, were censored at the CED. Cox Proportional Hazards (PH) Model was adjusted for age, and gender, including all 4 arms. A hazard ratio of less than 1 indicates a lower death rate versus placebo or other arm. ITT-E Population consisted of all participants in the Safety Population (i.e. randomized to IP and who received at least one dose of IP), with the exception of those recruited at sites that were closed.
Time Frame	From the date of randomization until date of death due to any cause (average of 2 study years)

Outcome Measure Data

Analysis Population Description

ITT-E Population

Arm/Group Title	Placebo	Fluticasone Furoate 100 µg	Vilanterol 25 µg	Fluticasone Furoate/Vilanterol 100/25 µg
Arm/Group Description	Participants received placebo once daily (OD) in the morning from the dry powder inhaler (DPI) until the required number of events (death) was achieved. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.	Participants received Fluticasone Furoate (FF) 100 microgram (µg) inhalation powder OD in the morning from the DPI until the required number of events (death) was achieved. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.	Participants received Vilanterol (VI) 25 µg inhalation powder OD in the morning from the DPI until the required number of events (death) was achieved. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.	Participants received FF/VI 100/25 µg inhalation powder OD in the morning from the DPI until the required number of events (death) was achieved. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
Measure Participants	4111	4135	4118	4121
Dead	275 6.7%	251 6%	265 6.4%	246 5.9%
Alive	3832 92.8%	3884 93.4%	3853 93.1%	3874 93.6%
Unknown	4 0.1%	0 0%	0 0%	1 0%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate/Vilanterol 100/25 µg
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.137
	Comments
	Method	Cox Proportional Hazards Model
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.878
	Confidence Interval	(2-Sided) 95%; 0.739 to 1.042
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate/Vilanterol 100/25 µg
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Percent reduction in risk of death
	Estimated Value	12.2
	Confidence Interval	(2-Sided) 95%; -4.2 to 26.1
	Parameter Dispersion	Type: Value:
	Estimation Comments	Confidence Interval (95%) and Estimated Value is presented for the percent reduction in risk of death at any time up to or on the CED, calculated as (1-hazard ratio)*100

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate 100 µg
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.284
	Comments
	Method	Cox Proportional Hazards Model
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.911
	Confidence Interval	(2-Sided) 95%; 0.767 to 1.081
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate 100 µg
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Percent reduction in risk of death
	Estimated Value	8.9
	Confidence Interval	(2-Sided) 95%; -8.1 to 23.3
	Parameter Dispersion	Type: Value:
	Estimation Comments	Confidence Interval (95%) and Estimated Value is presented for the percent reduction in risk of death at any time up to or on the CED, calculated as (1-hazard ratio)*100

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Placebo, Vilanterol 25 µg
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.655
	Comments
	Method	Cox Proportional Hazards Model
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.962
	Confidence Interval	(2-Sided) 95%; 0.813 to 1.139
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Placebo, Vilanterol 25 µg
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Percent reduction in risk of death
	Estimated Value	3.8
	Confidence Interval	(2-Sided) 95%; -13.9 to 18.7
	Parameter Dispersion	Type: Value:
	Estimation Comments	Confidence Interval (95%) and Estimated Value is presented for the percent reduction in risk of death at any time up to or on the CED, calculated as (1-hazard ratio)*100

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Fluticasone Furoate 100 µg, Fluticasone Furoate/Vilanterol 100/25 µg
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.681
	Comments
	Method	Cox Proportional Hazards Model
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.964
	Confidence Interval	(2-Sided) 95%; 0.808 to 1.149
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Fluticasone Furoate 100 µg, Fluticasone Furoate/Vilanterol 100/25 µg
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Percent reduction in risk of death
	Estimated Value	3.6
	Confidence Interval	(2-Sided) 95%; -14.9 to 19.2
	Parameter Dispersion	Type: Value:
	Estimation Comments	Confidence Interval (95%) and Estimated Value is presented for the percent reduction in risk of death at any time up to or on the CED, calculated as (1-hazard ratio)*100

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Vilanterol 25 µg, Fluticasone Furoate/Vilanterol 100/25 µg
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.299
	Comments
	Method	Cox Proportional Hazards Model
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.912
	Confidence Interval	(2-Sided) 95%; 0.767 to 1.085
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	Vilanterol 25 µg, Fluticasone Furoate/Vilanterol 100/25 µg
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Percent reduction in risk of death
	Estimated Value	8.8
	Confidence Interval	(2-Sided) 95%; -8.5 to 23.3
	Parameter Dispersion	Type: Value:
	Estimation Comments	Confidence Interval (95%) and Estimated Value is presented for the percent reduction in risk of death at any time up to or on the CED, calculated as (1-hazard ratio)*100

2. Secondary Outcome

Title	Decline in Forced Expiratory Volume in 1 Second (FEV1)
Description	FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. The effect of treatment on decline of post bronchodilator FEV1 recorded during the treatment period was analyzed using a particular form of a mixed effect model - a random coefficients model. FEV1 was fitted as the response variable with treatment group, age, gender, baseline FEV1 and time on treatment as fixed effects. Time on treatment was treated as a continuous variable. This model allowed for an initial increase in FEV1, but then tested the difference in slopes from the first post-baseline measurement which was at 3 months. A negative slope indicates a decline. A positive treatment difference indicates a slower rate of decline vs Placebo or Component. Only participants with at least one on-treatment post-bronchodilator FEV1 measurement were analyzed.
Time Frame	From start date of IP until IP stop date + 1 (assessed up to 4 years)

Outcome Measure Data

Analysis Population Description

ITT-E Population

Arm/Group Title	Placebo	Fluticasone Furoate 100 µg	Vilanterol 25 µg	Fluticasone Furoate/Vilanterol 100/25 µg
Arm/Group Description	Participants received placebo once daily (OD) in the morning from the dry powder inhaler (DPI) until the required number of events (death) was achieved. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.	Participants received Fluticasone Furoate (FF) 100 microgram (µg) inhalation powder OD in the morning from the DPI until the required number of events (death) was achieved. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.	Participants received Vilanterol (VI) 25 µg inhalation powder OD in the morning from the DPI until the required number of events (death) was achieved. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.	Participants received FF/VI 100/25 µg inhalation powder OD in the morning from the DPI until the required number of events (death) was achieved. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
Measure Participants	3800	3879	3866	3912
Least Squares Mean (Standard Error) [milliliter/year]	-46 (2.5)	-38 (2.4)	-47 (2.4)	-38 (2.4)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate/Vilanterol 100/25 µg
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.019
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	8
	Confidence Interval	(2-Sided) 95%; 1 to 15
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 3.4
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate 100 µg
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.026
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	8
	Confidence Interval	(2-Sided) 95%; 1 to 14
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 3.5
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, Vilanterol 25 µg
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.654
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-2
	Confidence Interval	(2-Sided) 95%; -8 to 5
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 3.4
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Fluticasone Furoate 100 µg, Fluticasone Furoate/Vilanterol 100/25 µg
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.913
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0
	Confidence Interval	(2-Sided) 95%; -6 to 7
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 3.4
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Vilanterol 25 µg, Fluticasone Furoate/Vilanterol 100/25 µg
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.004
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	10
	Confidence Interval	(2-Sided) 95%; 3 to 16
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 3.4
	Estimation Comments

3. Secondary Outcome

Title	Number of Participants With First On-treatment Cardiovascular (CV) Composite Events Occured on or Before Common End Date
Description	On-treatment CV composite event is comprised of the first event that is adjudicated as on-treatment CV death, myocardial infarction, stroke, unstable angina, or transient ischemic attack experienced by a participant. The events that occurred no more than 7 days after the participants last dose of IP are considered as on-treatment adverse events. Common end date is the study end date where approximately 1000 deaths would have occurred in the ITT-E Population. Cox PH Model was used to assess time to first on-treatment CV composite event. Cox PH Model was adjusted for age, gender and indicators of ischemic and vascular disease, including all four treatment arms. A hazard ratio less than 1 indicates a lower risk of a first CV event rate versus placebo or any arm.
Time Frame	From the start of IP to first on treatment CV event till 7 days after the last dose of IP (average of 2 study years)

Outcome Measure Data

Analysis Population Description

ITT-E Population

Arm/Group Title	Placebo	Fluticasone Furoate 100 µg	Vilanterol 25 µg	Fluticasone Furoate/Vilanterol 100/25 µg
Arm/Group Description	Participants received placebo once daily (OD) in the morning from the dry powder inhaler (DPI) until the required number of events (death) was achieved. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period	Participants received Fluticasone Furoate (FF) 100 microgram (µg) inhalation powder OD in the morning from the DPI until the required number of events (death) was achieved. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.	Participants received Vilanterol (VI) 25 µg inhalation powder OD in the morning from the DPI until the required number of events (death) was achieved. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.	Participants received FF/VI 100/25 µg inhalation powder OD in the morning from the DPI until the required number of events (death) was achieved. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
Measure Participants	4111	4135	4118	4121
Had CV composite event	173 4.2%	161 3.9%	180 4.3%	174 4.2%
No CV composite event	3938 95.3%	3974 95.6%	3938 95.1%	3947 95.3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate/Vilanterol 100/25 µg
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.475
	Comments
	Method	Cox Proportional Hazards Model
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.926
	Confidence Interval	(2-Sided) 95%; 0.750 to 1.143
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate/Vilanterol 100/25 µg
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Percent reduction in risk of CV event
	Estimated Value	7.4
	Confidence Interval	(2-Sided) 95%; -14.3 to 25.0
	Parameter Dispersion	Type: Value:
	Estimation Comments	Confidence Interval and Estimated Value is presented for the percent reduction in risk of death at any time up to or on the CED, calculated as (1-hazard ratio)*100

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate 100 µg
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.317
	Comments
	Method	Cox Proportional Hazards Model
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.896
	Confidence Interval	(2-Sided) 95%; 0.723 to 1.111
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate 100 µg
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Percent reduction in risk of CV event
	Estimated Value	10.4
	Confidence Interval	(2-Sided) 95%; -11.1 to 27.7
	Parameter Dispersion	Type: Value:
	Estimation Comments	Confidence Interval and Estimated Value is presented for the percent reduction in risk of death at any time up to or on the CED, calculated as (1-hazard ratio)*100

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Placebo, Vilanterol 25 µg
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.908
	Comments
	Method	Cox Proportional Hazards Model
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.988
	Confidence Interval	(2-Sided) 95%; 0.802 to 1.217
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Placebo, Vilanterol 25 µg
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Percent reduction in risk of death
	Estimated Value	1.2
	Confidence Interval	(2-Sided) 95%; -21.7 to 19.8
	Parameter Dispersion	Type: Value:
	Estimation Comments	Confidence Interval and Estimated Value is presented for the percent reduction in risk of death at any time up to or on the CED, calculated as (1-hazard ratio)*100

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Fluticasone Furoate 100 µg, Fluticasone Furoate/Vilanterol 100/25 µg
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.763
	Comments
	Method	Cox Proportional Hazards Model
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	1.033
	Confidence Interval	(2-Sided) 95%; 0.834 to 1.281
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Fluticasone Furoate 100 µg, Fluticasone Furoate/Vilanterol 100/25 µg
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Percent reduction in risk of death
	Estimated Value	-3.3
	Confidence Interval	(2-Sided) 95%; -28.1 to 16.6
	Parameter Dispersion	Type: Value:
	Estimation Comments	Confidence Interval and Estimated Value is presented for the percent reduction in risk of death at any time up to or on the CED, calculated as (1-hazard ratio)*100

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Vilanterol 25 µg, Fluticasone Furoate/Vilanterol 100/25 µg
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.545
	Comments
	Method	Cox Proportional Hazards Model
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.938
	Confidence Interval	(2-Sided) 95%; 0.761 to 1.155
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	Vilanterol 25 µg
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Percent reduction in risk of death
	Estimated Value	6.2
	Confidence Interval	(2-Sided) 95%; -15.5 to 23.9
	Parameter Dispersion	Type: Value:
	Estimation Comments	Confidence Interval and Estimated Value is presented for the percent reduction in risk of death at any time up to or on the CED, calculated as (1-hazard ratio)*100

Adverse Events

Time Frame	On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of IP until IP discontinuation + 1 day (average of 2 study years).
Adverse Event Reporting Description	On-treatment SAEs and non-serious AEs are reported for safety population, comprised of all participants randomized to treatment who received at least one dose IP.
Arm/Group Title	Placebo		Fluticasone Furoate 100 µg		Vilanterol 25 µg		Fluticasone Furoate/Vilanterol 100/25 µg
Arm/Group Description	Participants received placebo once daily (OD) in the morning from the dry powder inhaler (DPI) until the required number of events (death) was achieved. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.		Participants received Fluticasone Furoate (FF) 100 microgram (µg) inhalation powder OD in the morning from the DPI until the required number of events (death) was achieved. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.		Participants received Vilanterol (VI) 25 µg inhalation powder OD in the morning from the DPI until the required number of events (death) was achieved. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.		Participants received FF/VI 100/25 µg inhalation powder OD in the morning from the DPI until the required number of events (death) was achieved. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
All Cause Mortality
	Placebo		Fluticasone Furoate 100 µg		Vilanterol 25 µg		Fluticasone Furoate/Vilanterol 100/25 µg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Placebo		Fluticasone Furoate 100 µg		Vilanterol 25 µg		Fluticasone Furoate/Vilanterol 100/25 µg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	918/4131 (22.2%)		929/4157 (22.3%)		972/4140 (23.5%)		961/4140 (23.2%)
Blood and lymphatic system disorders
Agranulocytosis	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Anaemia	8/4131 (0.2%)		6/4157 (0.1%)		3/4140 (0.1%)		5/4140 (0.1%)
Bone marrow oedema	1/4131 (0%)		0/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Coagulopathy	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Febrile neutropenia	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		1/4140 (0%)
Haemorrhagic anaemia	0/4131 (0%)		1/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Hypercoagulation	1/4131 (0%)		0/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Hypersplenism	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Immune thrombocytopenic purpura	0/4131 (0%)		0/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Iron deficiency anaemia	2/4131 (0%)		2/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Leukocytosis	0/4131 (0%)		0/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Lymphadenopathy	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Lymphadenopathy mediastinal	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Microcytic anaemia	0/4131 (0%)		1/4157 (0%)		1/4140 (0%)		1/4140 (0%)
Neutropenia	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Normochromic normocytic anaemia	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Pancytopenia	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Polycythaemia	1/4131 (0%)		0/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Splenic vein thrombosis	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Spontaneous haematoma	1/4131 (0%)		0/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Thrombocytosis	1/4131 (0%)		0/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Cardiac disorders
Acute coronary syndrome	3/4131 (0.1%)		3/4157 (0.1%)		6/4140 (0.1%)		5/4140 (0.1%)
Acute left ventricular failure	1/4131 (0%)		1/4157 (0%)		2/4140 (0%)		2/4140 (0%)
Acute myocardial infarction	23/4131 (0.6%)		20/4157 (0.5%)		21/4140 (0.5%)		28/4140 (0.7%)
Adams-Stokes syndrome	1/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Angina pectoris	22/4131 (0.5%)		19/4157 (0.5%)		20/4140 (0.5%)		12/4140 (0.3%)
Angina unstable	23/4131 (0.6%)		22/4157 (0.5%)		16/4140 (0.4%)		23/4140 (0.6%)
Aortic valve disease	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Aortic valve incompetence	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		2/4140 (0%)
Aortic valve stenosis	1/4131 (0%)		0/4157 (0%)		0/4140 (0%)		3/4140 (0.1%)
Arrhythmia	1/4131 (0%)		4/4157 (0.1%)		3/4140 (0.1%)		6/4140 (0.1%)
Arrhythmia supraventricular	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Arteriosclerosis coronary artery	3/4131 (0.1%)		1/4157 (0%)		1/4140 (0%)		3/4140 (0.1%)
Atrial fibrillation	31/4131 (0.8%)		22/4157 (0.5%)		30/4140 (0.7%)		32/4140 (0.8%)
Atrial flutter	6/4131 (0.1%)		3/4157 (0.1%)		3/4140 (0.1%)		3/4140 (0.1%)
Atrial tachycardia	0/4131 (0%)		0/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Atrioventricular block	0/4131 (0%)		2/4157 (0%)		1/4140 (0%)		1/4140 (0%)
Atrioventricular block complete	3/4131 (0.1%)		2/4157 (0%)		3/4140 (0.1%)		3/4140 (0.1%)
Atrioventricular block first degree	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Atrioventricular block second degree	1/4131 (0%)		2/4157 (0%)		3/4140 (0.1%)		0/4140 (0%)
Bradyarrhythmia	1/4131 (0%)		1/4157 (0%)		1/4140 (0%)		1/4140 (0%)
Bradycardia	3/4131 (0.1%)		1/4157 (0%)		1/4140 (0%)		3/4140 (0.1%)
Bundle branch block left	0/4131 (0%)		0/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Bundle branch block right	0/4131 (0%)		0/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Cardiac arrest	9/4131 (0.2%)		9/4157 (0.2%)		11/4140 (0.3%)		4/4140 (0.1%)
Cardiac failure	28/4131 (0.7%)		17/4157 (0.4%)		19/4140 (0.5%)		28/4140 (0.7%)
Cardiac failure acute	7/4131 (0.2%)		3/4157 (0.1%)		3/4140 (0.1%)		7/4140 (0.2%)
Cardiac failure chronic	5/4131 (0.1%)		7/4157 (0.2%)		4/4140 (0.1%)		7/4140 (0.2%)
Cardiac failure congestive	26/4131 (0.6%)		26/4157 (0.6%)		21/4140 (0.5%)		30/4140 (0.7%)
Cardiac perforation	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Cardiac valve disease	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Cardiac ventricular thrombosis	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Cardio-respiratory arrest	11/4131 (0.3%)		9/4157 (0.2%)		11/4140 (0.3%)		5/4140 (0.1%)
Cardiogenic shock	2/4131 (0%)		1/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Cardiomegaly	1/4131 (0%)		0/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Cardiomyopathy	0/4131 (0%)		0/4157 (0%)		2/4140 (0%)		4/4140 (0.1%)
Cardiopulmonary failure	1/4131 (0%)		3/4157 (0.1%)		4/4140 (0.1%)		4/4140 (0.1%)
Cardiovascular disorder	1/4131 (0%)		2/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Cardiovascular insufficiency	0/4131 (0%)		0/4157 (0%)		2/4140 (0%)		0/4140 (0%)
Conduction disorder	1/4131 (0%)		0/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Congestive cardiomyopathy	2/4131 (0%)		2/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Cor pulmonale	1/4131 (0%)		2/4157 (0%)		0/4140 (0%)		2/4140 (0%)
Coronary artery disease	22/4131 (0.5%)		14/4157 (0.3%)		25/4140 (0.6%)		24/4140 (0.6%)
Coronary artery insufficiency	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Coronary artery occlusion	1/4131 (0%)		1/4157 (0%)		3/4140 (0.1%)		0/4140 (0%)
Coronary artery stenosis	1/4131 (0%)		2/4157 (0%)		1/4140 (0%)		2/4140 (0%)
Coronary artery thrombosis	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Coronary ostial stenosis	0/4131 (0%)		0/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Diastolic dysfunction	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Extrasystoles	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Hypertensive heart disease	0/4131 (0%)		1/4157 (0%)		2/4140 (0%)		0/4140 (0%)
Ischaemic cardiomyopathy	4/4131 (0.1%)		3/4157 (0.1%)		4/4140 (0.1%)		1/4140 (0%)
Left ventricular dysfunction	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Left ventricular failure	3/4131 (0.1%)		2/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Left ventricular hypertrophy	0/4131 (0%)		0/4157 (0%)		2/4140 (0%)		0/4140 (0%)
Mitral valve incompetence	2/4131 (0%)		0/4157 (0%)		0/4140 (0%)		2/4140 (0%)
Mitral valve stenosis	1/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Myocardial fibrosis	1/4131 (0%)		0/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Myocardial infarction	24/4131 (0.6%)		32/4157 (0.8%)		26/4140 (0.6%)		24/4140 (0.6%)
Myocardial ischaemia	7/4131 (0.2%)		8/4157 (0.2%)		5/4140 (0.1%)		7/4140 (0.2%)
Myocardial necrosis	0/4131 (0%)		0/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Myocarditis	1/4131 (0%)		0/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Pericardial effusion	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Pulseless electrical activity	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Rheumatic heart disease	1/4131 (0%)		0/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Right ventricular failure	0/4131 (0%)		0/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Sinoatrial block	0/4131 (0%)		1/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Sinus bradycardia	0/4131 (0%)		0/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Sinus node dysfunction	3/4131 (0.1%)		2/4157 (0%)		0/4140 (0%)		2/4140 (0%)
Sinus tachycardia	0/4131 (0%)		0/4157 (0%)		2/4140 (0%)		0/4140 (0%)
Supraventricular extrasystoles	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Supraventricular tachyarrhythmia	1/4131 (0%)		0/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Supraventricular tachycardia	0/4131 (0%)		0/4157 (0%)		3/4140 (0.1%)		0/4140 (0%)
Tachycardia	0/4131 (0%)		2/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Tachycardia paroxysmal	0/4131 (0%)		0/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Ventricle rupture	1/4131 (0%)		0/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Ventricular extrasystoles	1/4131 (0%)		1/4157 (0%)		1/4140 (0%)		1/4140 (0%)
Ventricular fibrillation	1/4131 (0%)		0/4157 (0%)		3/4140 (0.1%)		1/4140 (0%)
Ventricular tachycardia	0/4131 (0%)		3/4157 (0.1%)		2/4140 (0%)		3/4140 (0.1%)
Congenital, familial and genetic disorders
Adrenogenital syndrome	0/4131 (0%)		0/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Atrial septal defect	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Hydrocele	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		1/4140 (0%)
Pyloric stenosis	0/4131 (0%)		0/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Sturge-Weber syndrome	1/4131 (0%)		0/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Vitello-intestinal duct remnant	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Ear and labyrinth disorders
Meniere's disease	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Tinnitus	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Tympanic membrane perforation	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Vertigo	0/4131 (0%)		4/4157 (0.1%)		1/4140 (0%)		3/4140 (0.1%)
Vertigo positional	0/4131 (0%)		1/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Vestibular disorder	1/4131 (0%)		1/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Endocrine disorders
Addison's disease	0/4131 (0%)		0/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Adrenal insufficiency	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Autoimmune thyroiditis	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Basedow's disease	0/4131 (0%)		0/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Goitre	1/4131 (0%)		0/4157 (0%)		3/4140 (0.1%)		0/4140 (0%)
Hyperparathyroidism secondary	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Hyperthyroidism	0/4131 (0%)		0/4157 (0%)		0/4140 (0%)		2/4140 (0%)
Hypothyroidism	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Primary hyperaldosteronism	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Eye disorders
Angle closure glaucoma	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Blindness unilateral	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Cataract	1/4131 (0%)		5/4157 (0.1%)		8/4140 (0.2%)		6/4140 (0.1%)
Cataract cortical	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Diplopia	1/4131 (0%)		0/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Eye haemorrhage	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Eyelid ptosis	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		1/4140 (0%)
Glaucoma	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		1/4140 (0%)
Iridodonesis	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Lens dislocation	1/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Ocular hypertension	1/4131 (0%)		0/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Ocular ischaemic syndrome	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Retinal artery occlusion	1/4131 (0%)		0/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Retinal detachment	1/4131 (0%)		0/4157 (0%)		2/4140 (0%)		0/4140 (0%)
Retinal disorder	1/4131 (0%)		0/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Retinal tear	0/4131 (0%)		1/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Retinal vascular disorder	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Vitreous prolapse	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Gastrointestinal disorders
Abdominal distension	1/4131 (0%)		0/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Abdominal hernia	1/4131 (0%)		0/4157 (0%)		5/4140 (0.1%)		1/4140 (0%)
Abdominal incarcerated hernia	1/4131 (0%)		0/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Abdominal pain	0/4131 (0%)		3/4157 (0.1%)		2/4140 (0%)		3/4140 (0.1%)
Abdominal pain upper	2/4131 (0%)		0/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Acute abdomen	0/4131 (0%)		2/4157 (0%)		2/4140 (0%)		0/4140 (0%)
Anal fissure	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Anal fistula	0/4131 (0%)		1/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Ascites	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Chronic gastritis	0/4131 (0%)		2/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Colitis	2/4131 (0%)		1/4157 (0%)		0/4140 (0%)		2/4140 (0%)
Colitis ischaemic	0/4131 (0%)		0/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Colitis ulcerative	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		1/4140 (0%)
Constipation	2/4131 (0%)		0/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Crohn's disease	0/4131 (0%)		2/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Dental caries	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Diarrhoea	4/4131 (0.1%)		3/4157 (0.1%)		1/4140 (0%)		6/4140 (0.1%)
Dieulafoy's vascular malformation	1/4131 (0%)		0/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Diverticulum	1/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Diverticulum intestinal haemorrhagic	1/4131 (0%)		1/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Duodenal stenosis	1/4131 (0%)		0/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Duodenal ulcer	1/4131 (0%)		1/4157 (0%)		0/4140 (0%)		3/4140 (0.1%)
Duodenal ulcer haemorrhage	1/4131 (0%)		0/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Duodenitis	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Dyspepsia	0/4131 (0%)		0/4157 (0%)		0/4140 (0%)		2/4140 (0%)
Enteritis	0/4131 (0%)		1/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Enterocutaneous fistula	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Enterovesical fistula	0/4131 (0%)		1/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Erosive duodenitis	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Femoral hernia	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Gastric haemorrhage	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Gastric ulcer	0/4131 (0%)		2/4157 (0%)		4/4140 (0.1%)		0/4140 (0%)
Gastric ulcer haemorrhage	1/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Gastric ulcer perforation	0/4131 (0%)		1/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Gastritis	2/4131 (0%)		2/4157 (0%)		5/4140 (0.1%)		2/4140 (0%)
Gastritis erosive	1/4131 (0%)		0/4157 (0%)		1/4140 (0%)		1/4140 (0%)
Gastritis haemorrhagic	1/4131 (0%)		1/4157 (0%)		2/4140 (0%)		1/4140 (0%)
Gastroduodenal haemorrhage	0/4131 (0%)		0/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Gastrointestinal disorder	0/4131 (0%)		0/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Gastrointestinal haemorrhage	4/4131 (0.1%)		4/4157 (0.1%)		4/4140 (0.1%)		4/4140 (0.1%)
Gastrointestinal necrosis	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Gastrooesophageal reflux disease	2/4131 (0%)		1/4157 (0%)		0/4140 (0%)		2/4140 (0%)
Gingival bleeding	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Haematochezia	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Haemorrhoidal haemorrhage	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Haemorrhoids	2/4131 (0%)		2/4157 (0%)		2/4140 (0%)		1/4140 (0%)
Hiatus hernia	1/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Ileus	0/4131 (0%)		2/4157 (0%)		5/4140 (0.1%)		2/4140 (0%)
Ileus paralytic	2/4131 (0%)		0/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Incarcerated inguinal hernia	0/4131 (0%)		0/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Incarcerated umbilical hernia	1/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Inflammatory bowel disease	1/4131 (0%)		0/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Inguinal hernia	8/4131 (0.2%)		4/4157 (0.1%)		4/4140 (0.1%)		8/4140 (0.2%)
Inguinal hernia strangulated	1/4131 (0%)		0/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Intestinal infarction	1/4131 (0%)		0/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Intestinal ischaemia	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Intestinal obstruction	2/4131 (0%)		3/4157 (0.1%)		3/4140 (0.1%)		4/4140 (0.1%)
Intestinal perforation	1/4131 (0%)		0/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Intestinal polyp	1/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Intra-abdominal haemorrhage	0/4131 (0%)		0/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Irritable bowel syndrome	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Large intestinal stenosis	1/4131 (0%)		0/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Large intestine perforation	2/4131 (0%)		0/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Large intestine polyp	2/4131 (0%)		1/4157 (0%)		2/4140 (0%)		2/4140 (0%)
Lower gastrointestinal haemorrhage	1/4131 (0%)		2/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Mallory-Weiss syndrome	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Mechanical ileus	1/4131 (0%)		0/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Melaena	2/4131 (0%)		2/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Mouth ulceration	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Nausea	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Noninfective sialoadenitis	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Oedematous pancreatitis	0/4131 (0%)		0/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Oesophagitis ulcerative	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Pancreatic necrosis	0/4131 (0%)		0/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Pancreatitis	2/4131 (0%)		4/4157 (0.1%)		3/4140 (0.1%)		3/4140 (0.1%)
Pancreatitis acute	4/4131 (0.1%)		7/4157 (0.2%)		2/4140 (0%)		2/4140 (0%)
Pancreatitis chronic	2/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Peptic ulcer	2/4131 (0%)		2/4157 (0%)		3/4140 (0.1%)		2/4140 (0%)
Peptic ulcer haemorrhage	1/4131 (0%)		0/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Peptic ulcer perforation	1/4131 (0%)		0/4157 (0%)		1/4140 (0%)		1/4140 (0%)
Peritoneal adhesions	0/4131 (0%)		0/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Peritoneal haemorrhage	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Peritoneal perforation	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Proctitis	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Rectal haemorrhage	1/4131 (0%)		1/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Small intestinal obstruction	0/4131 (0%)		2/4157 (0%)		3/4140 (0.1%)		0/4140 (0%)
Small intestinal perforation	0/4131 (0%)		0/4157 (0%)		2/4140 (0%)		0/4140 (0%)
Subileus	0/4131 (0%)		0/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Umbilical hernia	1/4131 (0%)		0/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Upper gastrointestinal haemorrhage	3/4131 (0.1%)		5/4157 (0.1%)		1/4140 (0%)		2/4140 (0%)
Varices oesophageal	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Gastrointestinal tract adenoma	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
General disorders
Adverse drug reaction	1/4131 (0%)		0/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Asthenia	2/4131 (0%)		2/4157 (0%)		1/4140 (0%)		1/4140 (0%)
Cardiac death	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Chest discomfort	0/4131 (0%)		0/4157 (0%)		2/4140 (0%)		3/4140 (0.1%)
Chest pain	16/4131 (0.4%)		10/4157 (0.2%)		8/4140 (0.2%)		16/4140 (0.4%)
Cyst	0/4131 (0%)		0/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Death	6/4131 (0.1%)		7/4157 (0.2%)		5/4140 (0.1%)		7/4140 (0.2%)
Device defective	0/4131 (0%)		0/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Device deployment issue	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Device dislocation	0/4131 (0%)		0/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Device electrical finding	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Device failure	1/4131 (0%)		0/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Device issue	0/4131 (0%)		0/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Device malfunction	2/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Device occlusion	1/4131 (0%)		2/4157 (0%)		1/4140 (0%)		1/4140 (0%)
Electrocution	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Fatigue	0/4131 (0%)		2/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Gait disturbance	1/4131 (0%)		0/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Generalised oedema	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Hernia	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Impaired healing	2/4131 (0%)		0/4157 (0%)		3/4140 (0.1%)		0/4140 (0%)
Influenza like illness	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Medical device complication	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Multi-organ failure	2/4131 (0%)		3/4157 (0.1%)		2/4140 (0%)		6/4140 (0.1%)
Non-cardiac chest pain	4/4131 (0.1%)		5/4157 (0.1%)		10/4140 (0.2%)		3/4140 (0.1%)
Oedema peripheral	0/4131 (0%)		2/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Pain	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Pyrexia	2/4131 (0%)		0/4157 (0%)		2/4140 (0%)		1/4140 (0%)
Sudden cardiac death	3/4131 (0.1%)		7/4157 (0.2%)		6/4140 (0.1%)		1/4140 (0%)
Sudden death	20/4131 (0.5%)		14/4157 (0.3%)		17/4140 (0.4%)		20/4140 (0.5%)
Hepatobiliary disorders
Alcoholic liver disease	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Bile duct stenosis	0/4131 (0%)		1/4157 (0%)		1/4140 (0%)		2/4140 (0%)
Bile duct stone	1/4131 (0%)		1/4157 (0%)		0/4140 (0%)		3/4140 (0.1%)
Cholangitis	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		1/4140 (0%)
Cholecystitis	7/4131 (0.2%)		4/4157 (0.1%)		2/4140 (0%)		2/4140 (0%)
Cholecystitis acute	1/4131 (0%)		2/4157 (0%)		3/4140 (0.1%)		3/4140 (0.1%)
Cholecystitis chronic	1/4131 (0%)		1/4157 (0%)		2/4140 (0%)		1/4140 (0%)
Cholelithiasis	5/4131 (0.1%)		3/4157 (0.1%)		4/4140 (0.1%)		8/4140 (0.2%)
Chronic hepatitis	1/4131 (0%)		0/4157 (0%)		1/4140 (0%)		1/4140 (0%)
Hepatic cirrhosis	0/4131 (0%)		1/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Hepatic failure	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		1/4140 (0%)
Hepatic function abnormal	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Hepatic steatosis	2/4131 (0%)		0/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Hepatitis	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Hepatitis acute	1/4131 (0%)		0/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Hepatorenal failure	0/4131 (0%)		0/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Hepatorenal syndrome	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Hyperbilirubinaemia	1/4131 (0%)		0/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Jaundice cholestatic	0/4131 (0%)		1/4157 (0%)		1/4140 (0%)		1/4140 (0%)
Liver disorder	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Liver injury	1/4131 (0%)		0/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Portal hypertension	0/4131 (0%)		0/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Post cholecystectomy syndrome	1/4131 (0%)		0/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Immune system disorders
Anaphylactic reaction	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Anaphylactic shock	0/4131 (0%)		2/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Drug hypersensitivity	0/4131 (0%)		0/4157 (0%)		2/4140 (0%)		1/4140 (0%)
Food allergy	1/4131 (0%)		0/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Hypersensitivity	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Infections and infestations
Abdominal sepsis	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Abscess intestinal	0/4131 (0%)		0/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Abscess limb	1/4131 (0%)		0/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Abscess neck	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Acute hepatitis B	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Acute sinusitis	0/4131 (0%)		2/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Amoebiasis	1/4131 (0%)		0/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Anal abscess	1/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Appendicitis	3/4131 (0.1%)		1/4157 (0%)		1/4140 (0%)		2/4140 (0%)
Appendicitis perforated	1/4131 (0%)		0/4157 (0%)		1/4140 (0%)		1/4140 (0%)
Arthritis bacterial	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Atypical mycobacterial infection	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Biliary sepsis	1/4131 (0%)		0/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Biliary tract infection	0/4131 (0%)		0/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Breast abscess	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Bronchitis	12/4131 (0.3%)		9/4157 (0.2%)		6/4140 (0.1%)		6/4140 (0.1%)
Bronchitis bacterial	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Bronchopneumonia	3/4131 (0.1%)		8/4157 (0.2%)		7/4140 (0.2%)		4/4140 (0.1%)
Bronchopulmonary aspergillosis	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Cellulitis	5/4131 (0.1%)		10/4157 (0.2%)		0/4140 (0%)		6/4140 (0.1%)
Cholangitis infective	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Cholecystitis infective	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Clostridium difficile colitis	0/4131 (0%)		0/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Clostridium difficile infection	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Cystitis	0/4131 (0%)		1/4157 (0%)		2/4140 (0%)		0/4140 (0%)
Device related infection	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Diabetic foot infection	0/4131 (0%)		0/4157 (0%)		0/4140 (0%)		2/4140 (0%)
Diarrhoea infectious	0/4131 (0%)		3/4157 (0.1%)		1/4140 (0%)		1/4140 (0%)
Diverticulitis	4/4131 (0.1%)		2/4157 (0%)		3/4140 (0.1%)		3/4140 (0.1%)
Embolic pneumonia	0/4131 (0%)		0/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Emphysematous cystitis	1/4131 (0%)		0/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Endocarditis	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		3/4140 (0.1%)
Endophthalmitis	1/4131 (0%)		0/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Epididymitis	0/4131 (0%)		0/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Erysipelas	2/4131 (0%)		0/4157 (0%)		0/4140 (0%)		2/4140 (0%)
Escherichia sepsis	0/4131 (0%)		1/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Escherichia urinary tract infection	1/4131 (0%)		0/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Gallbladder empyema	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		1/4140 (0%)
Gangrene	3/4131 (0.1%)		3/4157 (0.1%)		1/4140 (0%)		2/4140 (0%)
Gastroenteritis	6/4131 (0.1%)		2/4157 (0%)		3/4140 (0.1%)		2/4140 (0%)
Gastroenteritis staphylococcal	1/4131 (0%)		0/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Gastrointestinal fungal infection	0/4131 (0%)		0/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Graft infection	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		1/4140 (0%)
Groin abscess	1/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Haematoma infection	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Hepatitis A	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Hepatitis C	1/4131 (0%)		0/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Hepatitis E	1/4131 (0%)		0/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Herpes zoster	0/4131 (0%)		2/4157 (0%)		3/4140 (0.1%)		2/4140 (0%)
Herpes zoster disseminated	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Incision site abscess	0/4131 (0%)		0/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Infected bites	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Infected skin ulcer	0/4131 (0%)		0/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Infection	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Infective exacerbation of chronic obstructive airways disea	4/4131 (0.1%)		6/4157 (0.1%)		3/4140 (0.1%)		6/4140 (0.1%)
Influenza	2/4131 (0%)		1/4157 (0%)		0/4140 (0%)		4/4140 (0.1%)
Intervertebral discitis	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Kidney infection	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Laryngitis	0/4131 (0%)		1/4157 (0%)		1/4140 (0%)		1/4140 (0%)
Lobar pneumonia	8/4131 (0.2%)		8/4157 (0.2%)		5/4140 (0.1%)		9/4140 (0.2%)
Lower respiratory tract infection	2/4131 (0%)		4/4157 (0.1%)		0/4140 (0%)		2/4140 (0%)
Lung abscess	0/4131 (0%)		2/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Lung infection	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Lymph gland infection	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Lymph node abscess	0/4131 (0%)		0/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Meningitis aseptic	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Meningoencephalitis herpetic	1/4131 (0%)		0/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Necrotising fasciitis	1/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Neuroborreliosis	0/4131 (0%)		0/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Orchitis	0/4131 (0%)		0/4157 (0%)		2/4140 (0%)		0/4140 (0%)
Oropharyngeal candidiasis	0/4131 (0%)		0/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Osteomyelitis	0/4131 (0%)		4/4157 (0.1%)		1/4140 (0%)		3/4140 (0.1%)
Otitis externa	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Otitis externa bacterial	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Parainfluenzae virus infection	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Periorbital cellulitis	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Peritonitis	1/4131 (0%)		2/4157 (0%)		4/4140 (0.1%)		3/4140 (0.1%)
Pharyngotonsillitis	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Pneumococcal infection	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Pneumonia	113/4131 (2.7%)		121/4157 (2.9%)		90/4140 (2.2%)		123/4140 (3%)
Pneumonia bacterial	1/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Pneumonia haemophilus	1/4131 (0%)		1/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Pneumonia moraxella	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Pneumonia staphylococcal	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Pneumonia streptococcal	1/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Postoperative wound infection	0/4131 (0%)		1/4157 (0%)		1/4140 (0%)		1/4140 (0%)
Pseudomembranous colitis	0/4131 (0%)		0/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Pulmonary tuberculosis	3/4131 (0.1%)		1/4157 (0%)		0/4140 (0%)		3/4140 (0.1%)
Purulent discharge	1/4131 (0%)		0/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Pyelocystitis	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Pyelonephritis	1/4131 (0%)		0/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Pyelonephritis acute	2/4131 (0%)		2/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Respiratory tract infection	1/4131 (0%)		2/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Respiratory tract infection bacterial	1/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Salmonella sepsis	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Scrotal abscess	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Sepsis	10/4131 (0.2%)		4/4157 (0.1%)		4/4140 (0.1%)		8/4140 (0.2%)
Septic shock	5/4131 (0.1%)		2/4157 (0%)		2/4140 (0%)		3/4140 (0.1%)
Sialoadenitis	1/4131 (0%)		0/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Sinusitis	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Skin infection	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Staphylococcal infection	1/4131 (0%)		0/4157 (0%)		2/4140 (0%)		0/4140 (0%)
Staphylococcal sepsis	0/4131 (0%)		0/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Thrombophlebitis septic	1/4131 (0%)		0/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Tooth abscess	1/4131 (0%)		0/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Toxic shock syndrome	0/4131 (0%)		0/4157 (0%)		2/4140 (0%)		0/4140 (0%)
Tuberculosis	1/4131 (0%)		3/4157 (0.1%)		0/4140 (0%)		1/4140 (0%)
Tuberculous pleurisy	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Typhoid fever	1/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Upper respiratory tract infection	3/4131 (0.1%)		1/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Urinary tract infection	5/4131 (0.1%)		7/4157 (0.2%)		6/4140 (0.1%)		9/4140 (0.2%)
Urinary tract infection bacterial	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Urosepsis	1/4131 (0%)		1/4157 (0%)		2/4140 (0%)		3/4140 (0.1%)
Vestibular neuronitis	1/4131 (0%)		0/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Viral myocarditis	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Wound infection	0/4131 (0%)		1/4157 (0%)		1/4140 (0%)		2/4140 (0%)
Injury, poisoning and procedural complications
Accidental overdose	1/4131 (0%)		0/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Acetabulum fracture	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Alcohol poisoning	0/4131 (0%)		0/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Anastomotic ulcer haemorrhage	0/4131 (0%)		0/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Ankle fracture	2/4131 (0%)		2/4157 (0%)		1/4140 (0%)		1/4140 (0%)
Brain contusion	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Burns third degree	2/4131 (0%)		0/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Cataract traumatic	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Cervical vertebral fracture	0/4131 (0%)		0/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Chemical burn of skin	0/4131 (0%)		0/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Chemical injury	1/4131 (0%)		0/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Clavicle fracture	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Comminuted fracture	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		1/4140 (0%)
Concussion	0/4131 (0%)		1/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Contusion	0/4131 (0%)		4/4157 (0.1%)		4/4140 (0.1%)		3/4140 (0.1%)
Coronary artery restenosis	0/4131 (0%)		0/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Coronary vascular graft occlusion	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Dislocation of vertebra	0/4131 (0%)		0/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Exposure via inhalation	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Eye contusion	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Facial bones fracture	0/4131 (0%)		0/4157 (0%)		2/4140 (0%)		0/4140 (0%)
Failure to anastomose	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Fall	4/4131 (0.1%)		2/4157 (0%)		4/4140 (0.1%)		4/4140 (0.1%)
Femoral neck fracture	2/4131 (0%)		4/4157 (0.1%)		2/4140 (0%)		3/4140 (0.1%)
Femur fracture	5/4131 (0.1%)		6/4157 (0.1%)		5/4140 (0.1%)		8/4140 (0.2%)
Fibula fracture	1/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Foot fracture	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Forearm fracture	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Gastrointestinal injury	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Gun shot wound	1/4131 (0%)		0/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Hand fracture	0/4131 (0%)		2/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Head injury	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Hepatic haematoma	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Hip fracture	1/4131 (0%)		2/4157 (0%)		1/4140 (0%)		3/4140 (0.1%)
Humerus fracture	3/4131 (0.1%)		4/4157 (0.1%)		1/4140 (0%)		3/4140 (0.1%)
Incisional hernia	2/4131 (0%)		1/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Intestinal anastomosis complication	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Joint capsule rupture	0/4131 (0%)		0/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Joint dislocation	0/4131 (0%)		1/4157 (0%)		1/4140 (0%)		2/4140 (0%)
Laceration	1/4131 (0%)		0/4157 (0%)		1/4140 (0%)		1/4140 (0%)
Ligament rupture	0/4131 (0%)		0/4157 (0%)		2/4140 (0%)		0/4140 (0%)
Limb crushing injury	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Limb traumatic amputation	0/4131 (0%)		0/4157 (0%)		0/4140 (0%)		11/4140 (0.3%)
Lower limb fracture	1/4131 (0%)		0/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Lumbar vertebral fracture	1/4131 (0%)		1/4157 (0%)		0/4140 (0%)		2/4140 (0%)
Meniscus injury	2/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Multiple fractures	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		1/4140 (0%)
Multiple injuries	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		1/4140 (0%)
Muscle injury	0/4131 (0%)		0/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Muscle rupture	1/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Overdose	2/4131 (0%)		1/4157 (0%)		1/4140 (0%)		1/4140 (0%)
Patella fracture	1/4131 (0%)		0/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Pelvic fracture	0/4131 (0%)		1/4157 (0%)		2/4140 (0%)		0/4140 (0%)
Periorbital contusion	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Periprosthetic fracture	1/4131 (0%)		0/4157 (0%)		1/4140 (0%)		3/4140 (0.1%)
Pneumothorax traumatic	1/4131 (0%)		0/4157 (0%)		2/4140 (0%)		0/4140 (0%)
Post laminectomy syndrome	0/4131 (0%)		0/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Post procedural complication	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Post procedural haematoma	0/4131 (0%)		0/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Post procedural haematuria	1/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Post procedural haemorrhage	1/4131 (0%)		0/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Postoperative hernia	0/4131 (0%)		0/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Postoperative ileus	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Postoperative respiratory failure	0/4131 (0%)		0/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Procedural complication	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Procedural pain	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Radiation pneumonitis	1/4131 (0%)		0/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Radius fracture	2/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Rib fracture	1/4131 (0%)		1/4157 (0%)		6/4140 (0.1%)		6/4140 (0.1%)
Road traffic accident	0/4131 (0%)		1/4157 (0%)		1/4140 (0%)		1/4140 (0%)
Scar	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Seroma	0/4131 (0%)		0/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Shunt thrombosis	0/4131 (0%)		0/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Skull fracture	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Soft tissue injury	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Spinal compression fracture	1/4131 (0%)		0/4157 (0%)		2/4140 (0%)		2/4140 (0%)
Sternal fracture	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Subdural haematoma	0/4131 (0%)		1/4157 (0%)		1/4140 (0%)		2/4140 (0%)
Tendon rupture	1/4131 (0%)		2/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Thoracic vertebral fracture	2/4131 (0%)		1/4157 (0%)		1/4140 (0%)		1/4140 (0%)
Tibia fracture	1/4131 (0%)		3/4157 (0.1%)		0/4140 (0%)		2/4140 (0%)
Toxicity to various agents	0/4131 (0%)		1/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Traumatic haematoma	1/4131 (0%)		0/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Traumatic haemothorax	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Traumatic intracranial haemorrhage	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Ulna fracture	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Upper limb fracture	0/4131 (0%)		0/4157 (0%)		2/4140 (0%)		0/4140 (0%)
Urethral injury	1/4131 (0%)		0/4157 (0%)		0/4140 (0%)		0/4140 (0%)
VIth nerve injury	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Vascular graft occlusion	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Vascular graft thrombosis	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Vascular pseudoaneurysm	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Wound	2/4131 (0%)		0/4157 (0%)		2/4140 (0%)		0/4140 (0%)
Wound evisceration	0/4131 (0%)		0/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Wrist fracture	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Investigations
Alanine aminotransferase increased	1/4131 (0%)		0/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Arteriogram coronary	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Blood glucose fluctuation	1/4131 (0%)		0/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Blood glucose increased	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Blood pressure increased	0/4131 (0%)		2/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Blood urine present	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Chest X-ray abnormal	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Hepatic enzyme increased	1/4131 (0%)		2/4157 (0%)		0/4140 (0%)		2/4140 (0%)
Liver function test abnormal	0/4131 (0%)		1/4157 (0%)		2/4140 (0%)		0/4140 (0%)
Myocardial necrosis marker increased	1/4131 (0%)		0/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Weight decreased	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Metabolism and nutrition disorders
Acidosis	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Cachexia	1/4131 (0%)		0/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Decreased appetite	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Dehydration	1/4131 (0%)		2/4157 (0%)		3/4140 (0.1%)		3/4140 (0.1%)
Diabetes mellitus	5/4131 (0.1%)		1/4157 (0%)		6/4140 (0.1%)		4/4140 (0.1%)
Diabetes mellitus inadequate control	4/4131 (0.1%)		6/4157 (0.1%)		2/4140 (0%)		1/4140 (0%)
Diabetic ketoacidosis	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Electrolyte imbalance	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Gout	1/4131 (0%)		0/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Hypercalcaemia	0/4131 (0%)		0/4157 (0%)		2/4140 (0%)		0/4140 (0%)
Hypercholesterolaemia	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Hyperglycaemia	0/4131 (0%)		2/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Hyperkalaemia	3/4131 (0.1%)		0/4157 (0%)		2/4140 (0%)		1/4140 (0%)
Hypertriglyceridaemia	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Hypoglycaemia	4/4131 (0.1%)		3/4157 (0.1%)		0/4140 (0%)		4/4140 (0.1%)
Hypokalaemia	2/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Hyponatraemia	2/4131 (0%)		1/4157 (0%)		4/4140 (0.1%)		1/4140 (0%)
Hypovolaemia	0/4131 (0%)		0/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Malnutrition	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Metabolic acidosis	1/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Obesity	0/4131 (0%)		0/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Type 2 diabetes mellitus	1/4131 (0%)		2/4157 (0%)		2/4140 (0%)		0/4140 (0%)
Vitamin D deficiency	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Musculoskeletal and connective tissue disorders
Arthralgia	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Arthritis	0/4131 (0%)		0/4157 (0%)		4/4140 (0.1%)		0/4140 (0%)
Arthrofibrosis	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Back pain	3/4131 (0.1%)		1/4157 (0%)		0/4140 (0%)		4/4140 (0.1%)
Bone lesion	1/4131 (0%)		0/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Bursitis	1/4131 (0%)		1/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Cervical spinal stenosis	1/4131 (0%)		0/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Chondrocalcinosis pyrophosphate	1/4131 (0%)		0/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Coccydynia	1/4131 (0%)		0/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Costochondritis	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Dupuytren's contracture	0/4131 (0%)		2/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Fibromyalgia	0/4131 (0%)		0/4157 (0%)		0/4140 (0%)		2/4140 (0%)
Foot deformity	1/4131 (0%)		0/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Fracture nonunion	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Gouty arthritis	0/4131 (0%)		1/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Intervertebral disc degeneration	1/4131 (0%)		0/4157 (0%)		2/4140 (0%)		2/4140 (0%)
Intervertebral disc disorder	0/4131 (0%)		2/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Intervertebral disc protrusion	3/4131 (0.1%)		3/4157 (0.1%)		5/4140 (0.1%)		2/4140 (0%)
Joint effusion	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Lumbar spinal stenosis	3/4131 (0.1%)		1/4157 (0%)		0/4140 (0%)		2/4140 (0%)
Muscle haemorrhage	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Muscular weakness	1/4131 (0%)		1/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Musculoskeletal chest pain	4/4131 (0.1%)		1/4157 (0%)		4/4140 (0.1%)		1/4140 (0%)
Musculoskeletal pain	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		2/4140 (0%)
Myopathy	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Myositis	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Neck pain	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Osteoarthritis	14/4131 (0.3%)		10/4157 (0.2%)		11/4140 (0.3%)		8/4140 (0.2%)
Osteochondrosis	2/4131 (0%)		1/4157 (0%)		0/4140 (0%)		3/4140 (0.1%)
Osteonecrosis	0/4131 (0%)		1/4157 (0%)		2/4140 (0%)		1/4140 (0%)
Pathological fracture	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Periarthritis	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Polyarthritis	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Polymyalgia rheumatica	0/4131 (0%)		0/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Rheumatoid arthritis	1/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Rotator cuff syndrome	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		1/4140 (0%)
Scoliosis	0/4131 (0%)		0/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Spinal column stenosis	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		1/4140 (0%)
Spinal disorder	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Spinal osteoarthritis	3/4131 (0.1%)		0/4157 (0%)		4/4140 (0.1%)		2/4140 (0%)
Spinal pain	1/4131 (0%)		0/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Spondylitis	1/4131 (0%)		0/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Spondylolisthesis	1/4131 (0%)		1/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Synovitis	1/4131 (0%)		0/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Systemic lupus erythematosus	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Tendonitis	1/4131 (0%)		0/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Tenosynovitis	1/4131 (0%)		0/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Vertebral foraminal stenosis	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ischaemic ulcer	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Acute leukaemia	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Acute lymphocytic leukaemia	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Acute myeloid leukaemia	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Adenocarcinoma	1/4131 (0%)		1/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Adenocarcinoma gastric	5/4131 (0.1%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Adenocarcinoma of colon	0/4131 (0%)		2/4157 (0%)		4/4140 (0.1%)		3/4140 (0.1%)
Adenocarcinoma of salivary gland	1/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Adenocarcinoma pancreas	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Adrenal adenoma	1/4131 (0%)		0/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Angiomyolipoma	1/4131 (0%)		0/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Astrocytoma	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
B-cell lymphoma	1/4131 (0%)		0/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Basal cell carcinoma	1/4131 (0%)		0/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Benign lung neoplasm	1/4131 (0%)		0/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Benign neoplasm of adrenal gland	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Benign neoplasm of bladder	0/4131 (0%)		1/4157 (0%)		1/4140 (0%)		1/4140 (0%)
Benign neoplasm of prostate	0/4131 (0%)		0/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Bile duct cancer	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Bladder cancer	0/4131 (0%)		5/4157 (0.1%)		1/4140 (0%)		5/4140 (0.1%)
Bladder cancer stage I, without cancer in situ	0/4131 (0%)		0/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Bladder neoplasm	1/4131 (0%)		1/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Bladder transitional cell carcinoma	3/4131 (0.1%)		3/4157 (0.1%)		5/4140 (0.1%)		0/4140 (0%)
Bladder transitional cell carcinoma recurrent	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Bladder transitional cell carcinoma stage 0	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Brain neoplasm	1/4131 (0%)		3/4157 (0.1%)		2/4140 (0%)		0/4140 (0%)
Brain neoplasm malignant	1/4131 (0%)		0/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Breast cancer	3/4131 (0.1%)		1/4157 (0%)		4/4140 (0.1%)		3/4140 (0.1%)
Breast cancer in situ	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Breast cancer metastatic	0/4131 (0%)		0/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Breast cancer stage I	0/4131 (0%)		0/4157 (0%)		2/4140 (0%)		1/4140 (0%)
Brenner tumour	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Bronchial carcinoma	4/4131 (0.1%)		1/4157 (0%)		1/4140 (0%)		2/4140 (0%)
Bronchioloalveolar carcinoma	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Carcinoid tumour	0/4131 (0%)		0/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Cervix carcinoma	1/4131 (0%)		0/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Cholangiocarcinoma	1/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Choroid melanoma	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Chronic lymphocytic leukaemia	1/4131 (0%)		0/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Chronic myeloid leukaemia	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Clear cell renal cell carcinoma	0/4131 (0%)		0/4157 (0%)		2/4140 (0%)		0/4140 (0%)
Colon cancer	1/4131 (0%)		3/4157 (0.1%)		5/4140 (0.1%)		4/4140 (0.1%)
Colon cancer recurrent	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Colon cancer stage IV	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Colon neoplasm	1/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Colorectal cancer	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Ear neoplasm malignant	1/4131 (0%)		0/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Endometrial adenocarcinoma	1/4131 (0%)		0/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Eyelid haemangioma	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Gallbladder cancer	1/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Gastric cancer	1/4131 (0%)		3/4157 (0.1%)		1/4140 (0%)		1/4140 (0%)
Gastric cancer stage I	1/4131 (0%)		0/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Gastric cancer stage III	1/4131 (0%)		0/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Gastrointestinal stromal tumour	0/4131 (0%)		1/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Glioblastoma	1/4131 (0%)		0/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Head and neck cancer	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Hepatic cancer	1/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Hepatic cancer metastatic	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Hepatic neoplasm	1/4131 (0%)		0/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Hepatocellular carcinoma	0/4131 (0%)		2/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Inflammatory pseudotumour	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Intestinal adenocarcinoma	0/4131 (0%)		0/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Intraductal proliferative breast lesion	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Invasive ductal breast carcinoma	1/4131 (0%)		0/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Keratoacanthoma	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Laryngeal cancer	1/4131 (0%)		2/4157 (0%)		2/4140 (0%)		1/4140 (0%)
Laryngeal squamous cell carcinoma	0/4131 (0%)		0/4157 (0%)		2/4140 (0%)		0/4140 (0%)
Lip and/or oral cavity cancer	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Lipoma	0/4131 (0%)		0/4157 (0%)		0/4140 (0%)		2/4140 (0%)
Lung adenocarcinoma	5/4131 (0.1%)		3/4157 (0.1%)		4/4140 (0.1%)		4/4140 (0.1%)
Lung adenocarcinoma metastatic	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		1/4140 (0%)
Lung adenocarcinoma stage I	0/4131 (0%)		2/4157 (0%)		2/4140 (0%)		0/4140 (0%)
Lung adenocarcinoma stage IV	1/4131 (0%)		0/4157 (0%)		1/4140 (0%)		1/4140 (0%)
Lung cancer metastatic	2/4131 (0%)		5/4157 (0.1%)		3/4140 (0.1%)		2/4140 (0%)
Lung carcinoma cell type unspecified recurrent	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Lung carcinoma cell type unspecified stage 0	1/4131 (0%)		0/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Lung carcinoma cell type unspecified stage III	0/4131 (0%)		0/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Lung carcinoma cell type unspecified stage IV	1/4131 (0%)		0/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Lung neoplasm	5/4131 (0.1%)		4/4157 (0.1%)		3/4140 (0.1%)		4/4140 (0.1%)
Lung neoplasm malignant	8/4131 (0.2%)		13/4157 (0.3%)		17/4140 (0.4%)		10/4140 (0.2%)
Lung squamous cell carcinoma metastatic	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Lung squamous cell carcinoma stage II	0/4131 (0%)		0/4157 (0%)		0/4140 (0%)		2/4140 (0%)
Lung squamous cell carcinoma stage III	1/4131 (0%)		0/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Lung squamous cell carcinoma stage IV	0/4131 (0%)		0/4157 (0%)		2/4140 (0%)		0/4140 (0%)
Lymphangiosis carcinomatosa	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Lymphocytic lymphoma	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Malignant melanoma	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Malignant neoplasm of ampulla of Vater	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Malignant neoplasm of choroid	0/4131 (0%)		0/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Meningioma	0/4131 (0%)		0/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Meningioma benign	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Mesenteric neoplasm	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Mesothelioma	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Metastases to adrenals	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		1/4140 (0%)
Metastases to bone	0/4131 (0%)		1/4157 (0%)		1/4140 (0%)		1/4140 (0%)
Metastases to bone marrow	1/4131 (0%)		0/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Metastases to central nervous system	1/4131 (0%)		2/4157 (0%)		2/4140 (0%)		4/4140 (0.1%)
Metastases to liver	6/4131 (0.1%)		2/4157 (0%)		9/4140 (0.2%)		4/4140 (0.1%)
Metastases to lung	1/4131 (0%)		3/4157 (0.1%)		1/4140 (0%)		1/4140 (0%)
Metastases to lymph nodes	1/4131 (0%)		1/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Metastases to peritoneum	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Metastases to skin	1/4131 (0%)		0/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Metastases to spine	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Metastases to spleen	1/4131 (0%)		0/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Metastases to stomach	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Metastatic malignant melanoma	0/4131 (0%)		0/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Metastatic neoplasm	1/4131 (0%)		0/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Metastatic renal cell carcinoma	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Myelodysplastic syndrome	1/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Myeloproliferative disorder	1/4131 (0%)		0/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Neoplasm malignant	1/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Neoplasm prostate	1/4131 (0%)		0/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Neuroendocrine tumour	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Non-Hodgkin's lymphoma	0/4131 (0%)		1/4157 (0%)		2/4140 (0%)		0/4140 (0%)
Non-small cell lung cancer	3/4131 (0.1%)		7/4157 (0.2%)		0/4140 (0%)		4/4140 (0.1%)
Non-small cell lung cancer stage I	1/4131 (0%)		0/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Non-small cell lung cancer stage II	0/4131 (0%)		0/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Non-small cell lung cancer stage IIIA	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		1/4140 (0%)
Non-small cell lung cancer stage IIIB	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Oesophageal adenocarcinoma	2/4131 (0%)		0/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Oesophageal carcinoma	1/4131 (0%)		1/4157 (0%)		2/4140 (0%)		1/4140 (0%)
Oesophageal squamous cell carcinoma	1/4131 (0%)		0/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Oesophageal squamous cell carcinoma metastatic	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Oesophageal squamous cell carcinoma stage II	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Oral neoplasm	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Oropharyngeal squamous cell carcinoma	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Ovarian cancer metastatic	1/4131 (0%)		0/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Ovarian germ cell teratoma benign	0/4131 (0%)		0/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Ovarian granulosa cell tumour	1/4131 (0%)		0/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Pancreatic carcinoma	6/4131 (0.1%)		1/4157 (0%)		4/4140 (0.1%)		4/4140 (0.1%)
Pancreatic carcinoma metastatic	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		1/4140 (0%)
Pancreatic neoplasm	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Papillary cystadenoma lymphomatosum	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Papillary thyroid cancer	0/4131 (0%)		0/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Phyllodes tumour	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Pituitary tumour benign	1/4131 (0%)		0/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Plasma cell myeloma	0/4131 (0%)		1/4157 (0%)		2/4140 (0%)		0/4140 (0%)
Polycythaemia vera	2/4131 (0%)		0/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Prostate cancer	5/4131 (0.1%)		4/4157 (0.1%)		8/4140 (0.2%)		11/4140 (0.3%)
Prostate cancer metastatic	0/4131 (0%)		0/4157 (0%)		2/4140 (0%)		0/4140 (0%)
Prostate cancer recurrent	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Prostatic adenoma	0/4131 (0%)		1/4157 (0%)		2/4140 (0%)		3/4140 (0.1%)
Rectal adenocarcinoma	3/4131 (0.1%)		0/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Rectal adenoma	0/4131 (0%)		0/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Rectal cancer	1/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Rectal neoplasm	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Renal cancer	1/4131 (0%)		0/4157 (0%)		0/4140 (0%)		3/4140 (0.1%)
Renal cell carcinoma	1/4131 (0%)		1/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Renal neoplasm	0/4131 (0%)		0/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Renal oncocytoma	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Retroperitoneal neoplasm	0/4131 (0%)		2/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Round cell liposarcoma	1/4131 (0%)		0/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Schwannoma	0/4131 (0%)		0/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Scrotal cancer	1/4131 (0%)		0/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Skin cancer	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Small cell lung cancer	4/4131 (0.1%)		3/4157 (0.1%)		3/4140 (0.1%)		6/4140 (0.1%)
Small cell lung cancer metastatic	2/4131 (0%)		0/4157 (0%)		2/4140 (0%)		0/4140 (0%)
Small intestine carcinoma	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Spinal cord neoplasm	0/4131 (0%)		0/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Squamous cell carcinoma	0/4131 (0%)		1/4157 (0%)		4/4140 (0.1%)		2/4140 (0%)
Squamous cell carcinoma of lung	6/4131 (0.1%)		6/4157 (0.1%)		5/4140 (0.1%)		12/4140 (0.3%)
Squamous cell carcinoma of skin	0/4131 (0%)		0/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Squamous cell carcinoma of the cervix	1/4131 (0%)		0/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Squamous cell carcinoma of the oral cavity	0/4131 (0%)		0/4157 (0%)		0/4140 (0%)		2/4140 (0%)
Squamous cell carcinoma of the tongue	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
T-cell lymphoma	0/4131 (0%)		0/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Throat cancer	1/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Thymoma malignant	0/4131 (0%)		0/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Thyroid neoplasm	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Tongue neoplasm malignant stage unspecified	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Tonsil cancer	0/4131 (0%)		0/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Transitional cell carcinoma	0/4131 (0%)		1/4157 (0%)		2/4140 (0%)		0/4140 (0%)
Ureteric cancer	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Uterine cancer	1/4131 (0%)		2/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Uterine leiomyoma	0/4131 (0%)		1/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Uterine leiomyosarcoma	0/4131 (0%)		0/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Vocal cord neoplasm	0/4131 (0%)		0/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Vulvar adenocarcinoma	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Diplegia	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Nervous system disorders
Amyotrophic lateral sclerosis	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Aphasia	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Ataxia	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Basal ganglia infarction	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Basilar artery occlusion	0/4131 (0%)		0/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Brain injury	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		1/4140 (0%)
Brain mass	1/4131 (0%)		0/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Brain oedema	0/4131 (0%)		1/4157 (0%)		1/4140 (0%)		1/4140 (0%)
Brain stem infarction	0/4131 (0%)		0/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Brain stem ischaemia	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Brain stem stroke	1/4131 (0%)		0/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Carotid arteriosclerosis	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Carotid artery aneurysm	1/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Carotid artery disease	0/4131 (0%)		0/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Carotid artery occlusion	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		2/4140 (0%)
Carotid artery stenosis	4/4131 (0.1%)		6/4157 (0.1%)		4/4140 (0.1%)		7/4140 (0.2%)
Carpal tunnel syndrome	1/4131 (0%)		0/4157 (0%)		0/4140 (0%)		3/4140 (0.1%)
Cerebellar atrophy	0/4131 (0%)		0/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Cerebellar syndrome	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Cerebral arteriosclerosis	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Cerebral atrophy	0/4131 (0%)		0/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Cerebral haematoma	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Cerebral haemorrhage	2/4131 (0%)		0/4157 (0%)		3/4140 (0.1%)		3/4140 (0.1%)
Cerebral infarction	5/4131 (0.1%)		6/4157 (0.1%)		4/4140 (0.1%)		7/4140 (0.2%)
Cerebral ischaemia	1/4131 (0%)		1/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Cerebral ventricle dilatation	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Cerebrospinal fluid leakage	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Cerebrovascular accident	16/4131 (0.4%)		11/4157 (0.3%)		11/4140 (0.3%)		18/4140 (0.4%)
Cerebrovascular disorder	2/4131 (0%)		1/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Cerebrovascular insufficiency	0/4131 (0%)		0/4157 (0%)		2/4140 (0%)		0/4140 (0%)
Cervical myelopathy	0/4131 (0%)		0/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Cervical radiculopathy	0/4131 (0%)		0/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Cognitive disorder	0/4131 (0%)		0/4157 (0%)		0/4140 (0%)		2/4140 (0%)
Coma	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Complex partial seizures	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Dementia	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Dementia Alzheimer's type	0/4131 (0%)		0/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Diabetic neuropathy	0/4131 (0%)		0/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Dizziness	0/4131 (0%)		2/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Encephalopathy	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		1/4140 (0%)
Epilepsy	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Generalised tonic-clonic seizure	0/4131 (0%)		0/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Haemorrhage intracranial	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Haemorrhagic cerebral infarction	1/4131 (0%)		0/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Haemorrhagic stroke	4/4131 (0.1%)		4/4157 (0.1%)		4/4140 (0.1%)		3/4140 (0.1%)
Headache	2/4131 (0%)		0/4157 (0%)		0/4140 (0%)		2/4140 (0%)
Hemiparesis	0/4131 (0%)		0/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Hemiplegia	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Hepatic encephalopathy	0/4131 (0%)		0/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Hypoaesthesia	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Hypoxic-ischaemic encephalopathy	1/4131 (0%)		0/4157 (0%)		0/4140 (0%)		1/4140 (0%)
IIIrd nerve paralysis	1/4131 (0%)		0/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Intercostal neuralgia	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Intracranial aneurysm	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Intraventricular haemorrhage	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Ischaemic cerebral infarction	2/4131 (0%)		0/4157 (0%)		2/4140 (0%)		0/4140 (0%)
Ischaemic stroke	19/4131 (0.5%)		15/4157 (0.4%)		14/4140 (0.3%)		19/4140 (0.5%)
Lacunar infarction	0/4131 (0%)		1/4157 (0%)		1/4140 (0%)		2/4140 (0%)
Loss of consciousness	0/4131 (0%)		1/4157 (0%)		1/4140 (0%)		2/4140 (0%)
Lumbar radiculopathy	1/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Meralgia paraesthetica	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Metabolic encephalopathy	1/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Migraine	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		1/4140 (0%)
Multiple sclerosis	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Myasthenia gravis	0/4131 (0%)		0/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Nerve compression	0/4131 (0%)		0/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Neurological symptom	1/4131 (0%)		0/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Neuropathy peripheral	0/4131 (0%)		0/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Normal pressure hydrocephalus	0/4131 (0%)		0/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Paraesthesia	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Parkinson's disease	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Peripheral sensory neuropathy	0/4131 (0%)		0/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Polyneuropathy	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Postictal paralysis	1/4131 (0%)		0/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Presyncope	1/4131 (0%)		0/4157 (0%)		0/4140 (0%)		2/4140 (0%)
Radicular syndrome	1/4131 (0%)		0/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Radiculopathy	1/4131 (0%)		0/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Sacral radiculopathy	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Sciatica	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Seizure	0/4131 (0%)		2/4157 (0%)		4/4140 (0.1%)		0/4140 (0%)
Speech disorder	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Spinal cord disorder	0/4131 (0%)		0/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Spondylitic myelopathy	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Subarachnoid haemorrhage	1/4131 (0%)		2/4157 (0%)		3/4140 (0.1%)		1/4140 (0%)
Syncope	6/4131 (0.1%)		7/4157 (0.2%)		6/4140 (0.1%)		10/4140 (0.2%)
Thoracic outlet syndrome	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Transient global amnesia	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Transient ischaemic attack	7/4131 (0.2%)		13/4157 (0.3%)		16/4140 (0.4%)		9/4140 (0.2%)
Trigeminal neuralgia	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Vascular encephalopathy	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		2/4140 (0%)
Vascular parkinsonism	1/4131 (0%)		0/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Vertebral artery stenosis	1/4131 (0%)		0/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Vertebrobasilar insufficiency	1/4131 (0%)		0/4157 (0%)		1/4140 (0%)		2/4140 (0%)
Psychiatric disorders
Affective disorder	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Alcohol abuse	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Alcohol withdrawal syndrome	1/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Alcoholism	1/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Anxiety	1/4131 (0%)		0/4157 (0%)		0/4140 (0%)		2/4140 (0%)
Bipolar disorder	0/4131 (0%)		0/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Completed suicide	1/4131 (0%)		1/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Confusional state	1/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Delirium	1/4131 (0%)		1/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Depression	1/4131 (0%)		2/4157 (0%)		1/4140 (0%)		2/4140 (0%)
Drug abuse	0/4131 (0%)		0/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Dysphoria	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Insomnia	1/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Major depression	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Mental status changes	2/4131 (0%)		3/4157 (0.1%)		1/4140 (0%)		1/4140 (0%)
Psychogenic seizure	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Schizoaffective disorder	0/4131 (0%)		0/4157 (0%)		0/4140 (0%)		2/4140 (0%)
Schizophrenia, paranoid type	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Substance abuse	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Substance-induced mood disorder	0/4131 (0%)		0/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Suicidal behaviour	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Suicidal ideation	0/4131 (0%)		0/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Hallucination, visual	1/4131 (0%)		0/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Renal and urinary disorders
Acute kidney injury	7/4131 (0.2%)		7/4157 (0.2%)		8/4140 (0.2%)		9/4140 (0.2%)
Acute prerenal failure	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Azotaemia	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Bladder neck sclerosis	1/4131 (0%)		0/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Bladder stenosis	1/4131 (0%)		0/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Calculus bladder	0/4131 (0%)		0/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Calculus ureteric	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Calculus urinary	2/4131 (0%)		1/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Chronic kidney disease	4/4131 (0.1%)		6/4157 (0.1%)		2/4140 (0%)		4/4140 (0.1%)
Cystitis haemorrhagic	1/4131 (0%)		0/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Diabetic nephropathy	1/4131 (0%)		0/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Dysuria	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Haematuria	4/4131 (0.1%)		1/4157 (0%)		2/4140 (0%)		2/4140 (0%)
Nephrolithiasis	0/4131 (0%)		2/4157 (0%)		4/4140 (0.1%)		4/4140 (0.1%)
Nocturia	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Obstructive uropathy	0/4131 (0%)		0/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Prerenal failure	1/4131 (0%)		0/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Renal cyst	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Renal failure	2/4131 (0%)		7/4157 (0.2%)		2/4140 (0%)		0/4140 (0%)
Renal mass	1/4131 (0%)		0/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Tubulointerstitial nephritis	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Urethral disorder	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Urethral stenosis	2/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Urinary bladder polyp	0/4131 (0%)		0/4157 (0%)		0/4140 (0%)		2/4140 (0%)
Urinary incontinence	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Urinary retention	1/4131 (0%)		4/4157 (0.1%)		1/4140 (0%)		2/4140 (0%)
Reproductive system and breast disorders
Benign prostatic hyperplasia	3/4131 (0.1%)		7/4157 (0.2%)		3/4140 (0.1%)		5/4140 (0.1%)
Breast pain	0/4131 (0%)		0/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Cervical polyp	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Cervix disorder	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Endometrial hyperplasia	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Fallopian tube cyst	1/4131 (0%)		0/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Peyronie's disease	1/4131 (0%)		0/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Prostatitis	1/4131 (0%)		1/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Prostatomegaly	0/4131 (0%)		0/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Uterine enlargement	1/4131 (0%)		0/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema	2/4131 (0%)		1/4157 (0%)		1/4140 (0%)		2/4140 (0%)
Acute respiratory distress syndrome	0/4131 (0%)		0/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Acute respiratory failure	17/4131 (0.4%)		7/4157 (0.2%)		8/4140 (0.2%)		12/4140 (0.3%)
Atelectasis	0/4131 (0%)		0/4157 (0%)		0/4140 (0%)		4/4140 (0.1%)
Bronchial polyp	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Bronchial secretion retention	1/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Bronchiectasis	1/4131 (0%)		1/4157 (0%)		1/4140 (0%)		1/4140 (0%)
Bronchospasm	0/4131 (0%)		0/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Bronchostenosis	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Bullous lung disease	0/4131 (0%)		0/4157 (0%)		2/4140 (0%)		0/4140 (0%)
Chronic obstructive pulmonary disease	262/4131 (6.3%)		214/4157 (5.1%)		245/4140 (5.9%)		189/4140 (4.6%)
Chronic respiratory failure	2/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Cough	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Dyspnoea	6/4131 (0.1%)		9/4157 (0.2%)		2/4140 (0%)		3/4140 (0.1%)
Dyspnoea at rest	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Emphysema	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		1/4140 (0%)
Epistaxis	0/4131 (0%)		2/4157 (0%)		2/4140 (0%)		2/4140 (0%)
Haemoptysis	2/4131 (0%)		8/4157 (0.2%)		3/4140 (0.1%)		4/4140 (0.1%)
Haemothorax	1/4131 (0%)		0/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Hypercapnia	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Hypoxia	2/4131 (0%)		1/4157 (0%)		3/4140 (0.1%)		1/4140 (0%)
Laryngeal disorder	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Laryngeal polyp	0/4131 (0%)		0/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Lung consolidation	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Lung disorder	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Lung infiltration	1/4131 (0%)		0/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Nasal septum deviation	0/4131 (0%)		1/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Nasal septum disorder	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Organising pneumonia	1/4131 (0%)		0/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Pharyngeal cyst	0/4131 (0%)		0/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Pickwickian syndrome	0/4131 (0%)		0/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Pleural effusion	6/4131 (0.1%)		3/4157 (0.1%)		3/4140 (0.1%)		9/4140 (0.2%)
Pleurisy	1/4131 (0%)		1/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Pneumonia aspiration	0/4131 (0%)		2/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Pneumonitis	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Pneumothorax	7/4131 (0.2%)		6/4157 (0.1%)		4/4140 (0.1%)		3/4140 (0.1%)
Pneumothorax spontaneous	1/4131 (0%)		1/4157 (0%)		1/4140 (0%)		2/4140 (0%)
Pulmonary congestion	0/4131 (0%)		1/4157 (0%)		3/4140 (0.1%)		0/4140 (0%)
Pulmonary embolism	10/4131 (0.2%)		12/4157 (0.3%)		17/4140 (0.4%)		13/4140 (0.3%)
Pulmonary fibrosis	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Pulmonary haemorrhage	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Pulmonary hilum mass	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Pulmonary hypertension	0/4131 (0%)		0/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Pulmonary mass	0/4131 (0%)		2/4157 (0%)		2/4140 (0%)		1/4140 (0%)
Pulmonary oedema	2/4131 (0%)		4/4157 (0.1%)		4/4140 (0.1%)		3/4140 (0.1%)
Respiratory distress	1/4131 (0%)		0/4157 (0%)		1/4140 (0%)		1/4140 (0%)
Respiratory failure	8/4131 (0.2%)		7/4157 (0.2%)		9/4140 (0.2%)		9/4140 (0.2%)
Sinus polyp	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Sleep apnoea syndrome	1/4131 (0%)		0/4157 (0%)		1/4140 (0%)		2/4140 (0%)
Vocal cord disorder	0/4131 (0%)		0/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Skin and subcutaneous tissue disorders
Hydrothorax	1/4131 (0%)		3/4157 (0.1%)		1/4140 (0%)		0/4140 (0%)
Angioedema	1/4131 (0%)		1/4157 (0%)		1/4140 (0%)		1/4140 (0%)
Dermal cyst	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Dermatitis allergic	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Dermatitis exfoliative	0/4131 (0%)		0/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Diabetic foot	2/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Erythema nodosum	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Idiopathic angioedema	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Neuropathic ulcer	0/4131 (0%)		0/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Photosensitivity reaction	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Pruritus	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Rash	0/4131 (0%)		0/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Skin lesion	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Skin maceration	0/4131 (0%)		0/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Skin oedema	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Skin sensitisation	1/4131 (0%)		0/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Skin ulcer	1/4131 (0%)		2/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Urticaria	2/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Surgical and medical procedures
Finger amputation	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Knee arthroplasty	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Rotator cuff repair	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Surgery	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Vascular disorders
Aortic aneurysm	10/4131 (0.2%)		8/4157 (0.2%)		5/4140 (0.1%)		4/4140 (0.1%)
Aortic aneurysm rupture	1/4131 (0%)		2/4157 (0%)		3/4140 (0.1%)		1/4140 (0%)
Aortic arteriosclerosis	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Aortic dilatation	0/4131 (0%)		0/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Aortic disorder	1/4131 (0%)		0/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Aortic dissection	1/4131 (0%)		0/4157 (0%)		1/4140 (0%)		1/4140 (0%)
Aortic stenosis	1/4131 (0%)		1/4157 (0%)		3/4140 (0.1%)		3/4140 (0.1%)
Aortic thrombosis	1/4131 (0%)		0/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Arterial disorder	0/4131 (0%)		0/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Arterial occlusive disease	0/4131 (0%)		0/4157 (0%)		0/4140 (0%)		3/4140 (0.1%)
Arterial rupture	1/4131 (0%)		0/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Arterial stenosis	0/4131 (0%)		0/4157 (0%)		0/4140 (0%)		2/4140 (0%)
Arterial thrombosis	1/4131 (0%)		0/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Arteriosclerosis	1/4131 (0%)		1/4157 (0%)		2/4140 (0%)		2/4140 (0%)
Arteriovenous fistula	1/4131 (0%)		0/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Circulatory collapse	1/4131 (0%)		2/4157 (0%)		0/4140 (0%)		3/4140 (0.1%)
Deep vein thrombosis	6/4131 (0.1%)		5/4157 (0.1%)		4/4140 (0.1%)		5/4140 (0.1%)
Diabetic microangiopathy	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Embolism	0/4131 (0%)		0/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Extremity necrosis	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Femoral artery occlusion	0/4131 (0%)		3/4157 (0.1%)		3/4140 (0.1%)		2/4140 (0%)
Haemorrhage	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Hypertension	7/4131 (0.2%)		9/4157 (0.2%)		8/4140 (0.2%)		11/4140 (0.3%)
Hypertensive crisis	3/4131 (0.1%)		5/4157 (0.1%)		5/4140 (0.1%)		9/4140 (0.2%)
Hypertensive emergency	2/4131 (0%)		0/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Hypotension	4/4131 (0.1%)		8/4157 (0.2%)		2/4140 (0%)		7/4140 (0.2%)
Hypovolaemic shock	0/4131 (0%)		0/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Iliac artery occlusion	2/4131 (0%)		2/4157 (0%)		3/4140 (0.1%)		2/4140 (0%)
Intermittent claudication	1/4131 (0%)		0/4157 (0%)		3/4140 (0.1%)		0/4140 (0%)
Leriche syndrome	0/4131 (0%)		0/4157 (0%)		2/4140 (0%)		2/4140 (0%)
Orthostatic hypotension	0/4131 (0%)		1/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Penetrating atherosclerotic ulcer	1/4131 (0%)		0/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Peripheral arterial occlusive disease	9/4131 (0.2%)		16/4157 (0.4%)		11/4140 (0.3%)		5/4140 (0.1%)
Peripheral artery aneurysm	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Peripheral artery stenosis	4/4131 (0.1%)		3/4157 (0.1%)		2/4140 (0%)		0/4140 (0%)
Peripheral artery thrombosis	2/4131 (0%)		3/4157 (0.1%)		1/4140 (0%)		3/4140 (0.1%)
Peripheral circulatory failure	0/4131 (0%)		0/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Peripheral embolism	1/4131 (0%)		0/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Peripheral ischaemia	4/4131 (0.1%)		3/4157 (0.1%)		3/4140 (0.1%)		4/4140 (0.1%)
Peripheral vascular disorder	1/4131 (0%)		8/4157 (0.2%)		3/4140 (0.1%)		3/4140 (0.1%)
Peripheral venous disease	1/4131 (0%)		0/4157 (0%)		0/4140 (0%)		2/4140 (0%)
Phlebitis	1/4131 (0%)		0/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Poor peripheral circulation	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Raynaud's phenomenon	1/4131 (0%)		0/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Renovascular hypertension	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Secondary hypertension	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Shock haemorrhagic	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Subclavian artery occlusion	1/4131 (0%)		0/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Subclavian artery stenosis	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Subclavian steal syndrome	1/4131 (0%)		0/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Temporal arteritis	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Thromboangiitis obliterans	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Thrombophlebitis	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Thrombosis	2/4131 (0%)		2/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Varicose vein	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Vascular occlusion	1/4131 (0%)		0/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Vascular stenosis	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		0/4140 (0%)
Vasoconstriction	0/4131 (0%)		0/4157 (0%)		0/4140 (0%)		1/4140 (0%)
Venous occlusion	0/4131 (0%)		2/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Venous thrombosis	0/4131 (0%)		0/4157 (0%)		1/4140 (0%)		1/4140 (0%)
Venous thrombosis limb	0/4131 (0%)		1/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Vessel perforation	1/4131 (0%)		0/4157 (0%)		0/4140 (0%)		0/4140 (0%)
Other (Not Including Serious) Adverse Events
	Placebo		Fluticasone Furoate 100 µg		Vilanterol 25 µg		Fluticasone Furoate/Vilanterol 100/25 µg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1862/4131 (45.1%)		1941/4157 (46.7%)		1827/4140 (44.1%)		1761/4140 (42.5%)
Infections and infestations
Bronchitis	165/4131 (4%)		184/4157 (4.4%)		168/4140 (4.1%)		166/4140 (4%)
Influenza	118/4131 (2.9%)		116/4157 (2.8%)		122/4140 (2.9%)		137/4140 (3.3%)
Nasopharyngitis	310/4131 (7.5%)		366/4157 (8.8%)		352/4140 (8.5%)		367/4140 (8.9%)
Upper respiratory tract infection	194/4131 (4.7%)		240/4157 (5.8%)		212/4140 (5.1%)		262/4140 (6.3%)
Musculoskeletal and connective tissue disorders
Back pain	140/4131 (3.4%)		168/4157 (4%)		162/4140 (3.9%)		173/4140 (4.2%)
Nervous system disorders
Headache	308/4131 (7.5%)		332/4157 (8%)		327/4140 (7.9%)		291/4140 (7%)
Dyspnoea	172/4131 (4.2%)		185/4157 (4.5%)		132/4140 (3.2%)		125/4140 (3%)
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease	969/4131 (23.5%)		939/4157 (22.6%)		938/4140 (22.7%)		779/4140 (18.8%)
Cough	254/4131 (6.1%)		224/4157 (5.4%)		215/4140 (5.2%)		206/4140 (5%)
Vascular disorders
Hypertension	129/4131 (3.1%)		138/4157 (3.3%)		124/4140 (3%)		152/4140 (3.7%)

Limitations/Caveats

[Not Specified]

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Principal Investigators are NOT employed by the organization sponsoring the study.

GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.