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A Phase 3 Study Comparing 2 Doses Of CP-690,550 And The Active Comparator, Humira (Adalimumab) Vs. Placebo For Treatment Of Rheumatoid Arthritis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00853385
First Posted: March 2, 2009
Last Update Posted: January 18, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Pfizer
Results First Submitted: December 4, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Rheumatoid Arthritis
Interventions: Drug: CP 690,550
Drug: CP-690,550
Other: Placebo
Biological: Biologic TNFi

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
CP-690,550 5 mg CP-690,550 5 milligram (mg) tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
CP-690,550 10 mg CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Placebo, Then CP-690,550 5 mg Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Placebo, Then CP-690,550 10 mg Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Adalimumab Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.

Participant Flow:   Overall Study
    CP-690,550 5 mg   CP-690,550 10 mg   Placebo, Then CP-690,550 5 mg   Placebo, Then CP-690,550 10 mg   Adalimumab
STARTED   204   201   56   52   204 
COMPLETED   150   158   47   39   162 
NOT COMPLETED   54   43   9   13   42 
Death                0                0                0                0                1 
Adverse Event                24                24                2                5                22 
Lack of Efficacy                6                7                3                3                6 
Lost to Follow-up                2                1                0                0                0 
Withdrawal by Subject                4                2                0                1                1 
Other                18                9                4                4                12 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
CP-690,550 5 mg CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
CP-690,550 10 mg CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Placebo, Then CP-690,550 5 mg Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Placebo, Then CP-690,550 10 mg Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Adalimumab Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
Total Total of all reporting groups

Baseline Measures
   CP-690,550 5 mg   CP-690,550 10 mg   Placebo, Then CP-690,550 5 mg   Placebo, Then CP-690,550 10 mg   Adalimumab   Total 
Overall Participants Analyzed 
[Units: Participants]
 204   201   56   52   204   717 
Age 
[Units: Years]
Mean (Standard Deviation)
 53.0  (11.9)   52.9  (11.8)   55.5  (13.7)   51.9  (13.7)   52.5  (11.7)   52.9  (12.1) 
Gender 
[Units: Participants]
           
Female   174   168   43   39   162   586 
Male   30   33   13   13   42   131 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 6   [ Time Frame: Month 6 ]

2.  Primary:   Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) at Month 3   [ Time Frame: Baseline, Month 3 ]

3.  Primary:   Percentage of Participants With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 at Month 6   [ Time Frame: Month 6 ]

4.  Secondary:   Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 1 and 3   [ Time Frame: Month 1, 3 ]

5.  Secondary:   Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 9 and 12   [ Time Frame: Month 9, 12 ]

6.  Secondary:   Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Month 1, 3 and 6   [ Time Frame: Month 1, 3, 6 ]

7.  Secondary:   Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Month 9 and 12   [ Time Frame: Month 9, 12 ]

8.  Secondary:   Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Month 1, 3 and 6   [ Time Frame: Month 1, 3, 6 ]

9.  Secondary:   Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Month 9 and 12   [ Time Frame: Month 9, 12 ]

10.  Secondary:   Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Month 1, 3 and 6   [ Time Frame: Baseline, Month 1, 3, 6 ]

11.  Secondary:   Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Month 9 and 12   [ Time Frame: Month 9, 12 ]

12.  Secondary:   Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Baseline, Month 1, 3 and 6   [ Time Frame: Baseline, Month 1, 3, 6 ]

13.  Secondary:   Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Month 9 and 12   [ Time Frame: Month 9, 12 ]

14.  Secondary:   Disease Activity Score Using 28-Joint Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP])   [ Time Frame: Baseline, Month 1, 3, 6, 9, 12 ]

15.  Secondary:   Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (3 Variables) (DAS28-3 [ESR])   [ Time Frame: Baseline, Month 1, 3, 6, 9, 12 ]

16.  Secondary:   Health Assessment Questionnaire-Disability Index (HAQ-DI) at Month 1, 3 and 6   [ Time Frame: Month 1, 3, 6 ]

17.  Secondary:   Health Assessment Questionnaire-Disability Index (HAQ-DI) at Month 9 and 12   [ Time Frame: Month 9, 12 ]

18.  Secondary:   Patient Assessment of Arthritis Pain at Baseline, Month 1, 3 and 6   [ Time Frame: Baseline, Month 1, 3, 6 ]

19.  Secondary:   Patient Assessment of Arthritis Pain at Month 9 and 12   [ Time Frame: Month 9, 12 ]

20.  Secondary:   Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Month 1, 3 and 6   [ Time Frame: Baseline, Month 1, 3, 6 ]

21.  Secondary:   Patient Global Assessment (PtGA) of Arthritis Pain at Month 9 and 12   [ Time Frame: Month 9, 12 ]

22.  Secondary:   Physician Global Assessment (PGA) of Arthritis Pain at Baseline, Month 1, 3 and 6   [ Time Frame: Baseline, Month 1, 3, 6 ]

23.  Secondary:   Physician Global Assessment (PGA) of Arthritis Pain at Month 9 and 12   [ Time Frame: Month 9, 12 ]

24.  Secondary:   36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6   [ Time Frame: Baseline, Month 1, 3, 6 ]

25.  Secondary:   36-Item Short-Form Health Survey (SF-36) at Month 9 and 12   [ Time Frame: Month 9, 12 ]

26.  Secondary:   Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT)-Fatigue Scale at Baseline, Month 1, 3 and 6   [ Time Frame: Baseline, Month 1, 3, 6 ]

27.  Secondary:   Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT)-Fatigue Scale at Month 12   [ Time Frame: Month 12 ]

28.  Secondary:   Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6   [ Time Frame: Baseline, Month 1, 3, 6 ]

29.  Secondary:   Medical Outcomes Study-Sleep Scale (MOS-SS) at Month 12   [ Time Frame: Month 12 ]

30.  Secondary:   Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6   [ Time Frame: Baseline, Month 1, 3, 6 ]

31.  Secondary:   Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study-Sleep Scale (MOS-SS) at Month 12   [ Time Frame: Month 12 ]

32.  Secondary:   Euro Quality of Life-5 Dimension (EQ-5D) Health State Profile Utility Score at Baseline, Month 1, 3 and 6   [ Time Frame: Baseline, Month 1, 3, 6 ]

33.  Secondary:   Euro Quality of Life-5 Dimension (EQ-5D) Health State Profile Utility Score at Month 12   [ Time Frame: Month 12 ]

34.  Secondary:   Work Limitations Questionnaire (WLQ) Score at Month 3 and 6   [ Time Frame: Month 3, 6 ]

35.  Secondary:   Work Limitations Questionnaire (WLQ) Score at Baseline and Month 12   [ Time Frame: Baseline, Month 12 ]

36.  Secondary:   Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6   [ Time Frame: Baseline, Month 3, 6 ]

37.  Secondary:   Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12   [ Time Frame: Month 12 ]

38.  Secondary:   Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6   [ Time Frame: Baseline, Month 3, 6 ]

39.  Secondary:   Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12   [ Time Frame: Month 12 ]

40.  Secondary:   Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6   [ Time Frame: Baseline, Month 3, 6 ]

41.  Secondary:   Number of Days as Assessed Using RA-HCRU at Month 12   [ Time Frame: Month 12 ]

42.  Secondary:   Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6   [ Time Frame: Baseline, Month 3, 6 ]

43.  Secondary:   Number of Hours Per Day as Assessed RA-HCRU at Month 12   [ Time Frame: Month 12 ]

44.  Secondary:   Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Baseline, Month 3 and 6   [ Time Frame: Baseline, Month 3, 6 ]

45.  Secondary:   Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Month 12   [ Time Frame: Month 12 ]


  Serious Adverse Events
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Time Frame Baseline Through Month 12
Additional Description The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.

Reporting Groups
  Description
CP-690,550 5 mg (Up To Month 3) CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 3.
CP-690,550 10 mg (Up To Month 3) CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 3.
Placebo (Up To Month 3) Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Adalimumab (Up To Month 3) Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 3.
CP-690,550 5 mg (Month 3 to 6) CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week from Month 3 to Month 6.
CP-690,550 10 mg (Month 3 to 6) CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week from Month 3 to Month 6.
Placebo (Month 3 to 6) Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Adalimumab (Month 3 to 6) Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily from Month 3 to Month 6.
CP-690,550 5 mg (Post Month 6) CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week from Month 6 to Month 12.
CP-690,550 10 mg (Post Month 6) CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week from Month 6 to Month 12.
Adalimumab (Post Month 6) Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily from Month 6 to Month 12.

Serious Adverse Events
    CP-690,550 5 mg (Up To Month 3)   CP-690,550 10 mg (Up To Month 3)   Placebo (Up To Month 3)   Adalimumab (Up To Month 3)   CP-690,550 5 mg (Month 3 to 6)   CP-690,550 10 mg (Month 3 to 6)   Placebo (Month 3 to 6)   Adalimumab (Month 3 to 6)   CP-690,550 5 mg (Post Month 6)   CP-690,550 10 mg (Post Month 6)   Adalimumab (Post Month 6)
Total, Serious Adverse Events                       
# participants affected / at risk   12/204 (5.88%)   10/201 (4.98%)   2/108 (1.85%)   5/204 (2.45%)   10/232 (4.31%)   7/222 (3.15%)   2/59 (3.39%)   6/204 (2.94%)   11/260 (4.23%)   10/253 (3.95%)   7/204 (3.43%) 
Cardiac disorders                       
Acute myocardial infarction * 1                       
# participants affected / at risk   0/204 (0.00%)   0/201 (0.00%)   0/108 (0.00%)   1/204 (0.49%)   0/232 (0.00%)   0/222 (0.00%)   0/59 (0.00%)   0/204 (0.00%)   0/260 (0.00%)   0/253 (0.00%)   0/204 (0.00%) 
Atrioventricular block complete * 1                       
# participants affected / at risk   0/204 (0.00%)   0/201 (0.00%)   1/108 (0.93%)   0/204 (0.00%)   0/232 (0.00%)   0/222 (0.00%)   0/59 (0.00%)   0/204 (0.00%)   0/260 (0.00%)   0/253 (0.00%)   0/204 (0.00%) 
Cardiac arrest * 1                       
# participants affected / at risk   0/204 (0.00%)   0/201 (0.00%)   0/108 (0.00%)   1/204 (0.49%)   0/232 (0.00%)   0/222 (0.00%)   0/59 (0.00%)   0/204 (0.00%)   0/260 (0.00%)   0/253 (0.00%)   0/204 (0.00%) 
Myocardial infarction * 1                       
# participants affected / at risk   0/204 (0.00%)   1/201 (0.50%)   0/108 (0.00%)   0/204 (0.00%)   1/232 (0.43%)   0/222 (0.00%)   0/59 (0.00%)   0/204 (0.00%)   0/260 (0.00%)   0/253 (0.00%)   1/204 (0.49%) 
Myocardial ischaemia * 1                       
# participants affected / at risk   0/204 (0.00%)   0/201 (0.00%)   0/108 (0.00%)   0/204 (0.00%)   0/232 (0.00%)   0/222 (0.00%)   0/59 (0.00%)   1/204 (0.49%)   0/260 (0.00%)   0/253 (0.00%)   0/204 (0.00%) 
Cardiac failure congestive * 1                       
# participants affected / at risk   0/204 (0.00%)   0/201 (0.00%)   0/108 (0.00%)   0/204 (0.00%)   0/232 (0.00%)   0/222 (0.00%)   0/59 (0.00%)   0/204 (0.00%)   0/260 (0.00%)   1/253 (0.40%)   0/204 (0.00%) 
Ear and labyrinth disorders                       
Vertigo * 1                       
# participants affected / at risk   0/204 (0.00%)   1/201 (0.50%)   0/108 (0.00%)   0/204 (0.00%)   0/232 (0.00%)   0/222 (0.00%)   0/59 (0.00%)   0/204 (0.00%)   0/260 (0.00%)   0/253 (0.00%)   0/204 (0.00%) 
Endocrine disorders                       
Autoimmune thyroiditis * 1                       
# participants affected / at risk   0/204 (0.00%)   0/201 (0.00%)   0/108 (0.00%)   0/204 (0.00%)   0/232 (0.00%)   0/222 (0.00%)   0/59 (0.00%)   0/204 (0.00%)   1/260 (0.38%)   0/253 (0.00%)   0/204 (0.00%) 
Eye disorders                       
Retinal detachment * 1                       
# participants affected / at risk   0/204 (0.00%)   0/201 (0.00%)   0/108 (0.00%)   0/204 (0.00%)   0/232 (0.00%)   1/222 (0.45%)   0/59 (0.00%)   0/204 (0.00%)   0/260 (0.00%)   0/253 (0.00%)   0/204 (0.00%) 
Gastrointestinal disorders                       
Anal polyp * 1                       
# participants affected / at risk   0/204 (0.00%)   1/201 (0.50%)   0/108 (0.00%)   0/204 (0.00%)   0/232 (0.00%)   0/222 (0.00%)   0/59 (0.00%)   0/204 (0.00%)   0/260 (0.00%)   0/253 (0.00%)   0/204 (0.00%) 
Diverticular perforation * 1                       
# participants affected / at risk   0/204 (0.00%)   1/201 (0.50%)   0/108 (0.00%)   0/204 (0.00%)   0/232 (0.00%)   0/222 (0.00%)   0/59 (0.00%)   0/204 (0.00%)   0/260 (0.00%)   0/253 (0.00%)   0/204 (0.00%) 
Salivary gland calculus * 1                       
# participants affected / at risk   0/204 (0.00%)   0/201 (0.00%)   1/108 (0.93%)   0/204 (0.00%)   0/232 (0.00%)   0/222 (0.00%)   0/59 (0.00%)   0/204 (0.00%)   0/260 (0.00%)   0/253 (0.00%)   0/204 (0.00%) 
Haematemesis * 1                       
# participants affected / at risk   0/204 (0.00%)   0/201 (0.00%)   0/108 (0.00%)   0/204 (0.00%)   0/232 (0.00%)   0/222 (0.00%)   0/59 (0.00%)   1/204 (0.49%)   0/260 (0.00%)   0/253 (0.00%)   0/204 (0.00%) 
Haematochezia * 1                       
# participants affected / at risk   0/204 (0.00%)   0/201 (0.00%)   0/108 (0.00%)   0/204 (0.00%)   0/232 (0.00%)   0/222 (0.00%)   0/59 (0.00%)   1/204 (0.49%)   0/260 (0.00%)   0/253 (0.00%)   0/204 (0.00%) 
Peptic ulcer haemorrhage * 1                       
# participants affected / at risk   0/204 (0.00%)   0/201 (0.00%)   0/108 (0.00%)   0/204 (0.00%)   0/232 (0.00%)   1/222 (0.45%)   0/59 (0.00%)   0/204 (0.00%)   0/260 (0.00%)   0/253 (0.00%)   0/204 (0.00%) 
Abdominal hernia * 1                       
# participants affected / at risk   0/204 (0.00%)   0/201 (0.00%)   0/108 (0.00%)   0/204 (0.00%)   0/232 (0.00%)   0/222 (0.00%)   0/59 (0.00%)   0/204 (0.00%)   0/260 (0.00%)   0/253 (0.00%)   1/204 (0.49%) 
Ileus * 1                       
# participants affected / at risk   0/204 (0.00%)   0/201 (0.00%)   0/108 (0.00%)   0/204 (0.00%)   0/232 (0.00%)   0/222 (0.00%)   0/59 (0.00%)   0/204 (0.00%)   0/260 (0.00%)   1/253 (0.40%)   0/204 (0.00%) 
General disorders                       
Impaired healing * 1                       
# participants affected / at risk   1/204 (0.49%)   0/201 (0.00%)   0/108 (0.00%)   0/204 (0.00%)   0/232 (0.00%)   0/222 (0.00%)   0/59 (0.00%)   0/204 (0.00%)   0/260 (0.00%)   0/253 (0.00%)   0/204 (0.00%) 
Pyrexia * 1                       
# participants affected / at risk   0/204 (0.00%)   0/201 (0.00%)   0/108 (0.00%)   0/204 (0.00%)   0/232 (0.00%)   1/222 (0.45%)   0/59 (0.00%)   0/204 (0.00%)   0/260 (0.00%)   0/253 (0.00%)   0/204 (0.00%) 
Chest pain * 1                       
# participants affected / at risk   0/204 (0.00%)   0/201 (0.00%)   0/108 (0.00%)   0/204 (0.00%)   0/232 (0.00%)   0/222 (0.00%)   0/59 (0.00%)   0/204 (0.00%)   0/260 (0.00%)   0/253 (0.00%)   1/204 (0.49%) 
Hepatobiliary disorders                       
Cholecystitis * 1                       
# participants affected / at risk   1/204 (0.49%)   0/201 (0.00%)   0/108 (0.00%)   0/204 (0.00%)   0/232 (0.00%)   0/222 (0.00%)   0/59 (0.00%)   0/204 (0.00%)   0/260 (0.00%)   0/253 (0.00%)   0/204 (0.00%) 
Cholecystitis acute * 1                       
# participants affected / at risk   0/204 (0.00%)   0/201 (0.00%)   0/108 (0.00%)   1/204 (0.49%)   0/232 (0.00%)   0/222 (0.00%)   0/59 (0.00%)   0/204 (0.00%)   0/260 (0.00%)   0/253 (0.00%)   0/204 (0.00%) 
Cholelithiasis * 1                       
# participants affected / at risk   1/204 (0.49%)   0/201 (0.00%)   0/108 (0.00%)   0/204 (0.00%)   0/232 (0.00%)   0/222 (0.00%)   0/59 (0.00%)   0/204 (0.00%)   0/260 (0.00%)   1/253 (0.40%)   0/204 (0.00%) 
Infections and infestations                       
Arthritis bacterial * 1                       
# participants affected / at risk   0/204 (0.00%)   1/201 (0.50%)   0/108 (0.00%)   0/204 (0.00%)   0/232 (0.00%)   0/222 (0.00%)   0/59 (0.00%)   0/204 (0.00%)   0/260 (0.00%)   0/253 (0.00%)   0/204 (0.00%) 
Cellulitis * 1                       
# participants affected / at risk   2/204 (0.98%)   1/201 (0.50%)   0/108 (0.00%)   0/204 (0.00%)   1/232 (0.43%)   0/222 (0.00%)   0/59 (0.00%)   1/204 (0.49%)   0/260 (0.00%)   0/253 (0.00%)   0/204 (0.00%) 
Herpes zoster * 1                       
# participants affected / at risk   0/204 (0.00%)   1/201 (0.50%)   0/108 (0.00%)   0/204 (0.00%)   0/232 (0.00%)   0/222 (0.00%)   0/59 (0.00%)   0/204 (0.00%)   1/260 (0.38%)   0/253 (0.00%)   0/204 (0.00%) 
Labyrinthitis * 1                       
# participants affected / at risk   0/204 (0.00%)   1/201 (0.50%)   0/108 (0.00%)   0/204 (0.00%)   0/232 (0.00%)   0/222 (0.00%)   0/59 (0.00%)   0/204 (0.00%)   0/260 (0.00%)   0/253 (0.00%)   0/204 (0.00%) 
Osteomyelitis * 1                       
# participants affected / at risk   1/204 (0.49%)   0/201 (0.00%)   0/108 (0.00%)   0/204 (0.00%)   0/232 (0.00%)   0/222 (0.00%)   0/59 (0.00%)   0/204 (0.00%)   0/260 (0.00%)   0/253 (0.00%)   0/204 (0.00%) 
Sialoadenitis * 1                       
# participants affected / at risk   0/204 (0.00%)   0/201 (0.00%)   1/108 (0.93%)   0/204 (0.00%)   0/232 (0.00%)   0/222 (0.00%)   0/59 (0.00%)   0/204 (0.00%)   0/260 (0.00%)   0/253 (0.00%)   0/204 (0.00%) 
Tooth abscess * 1                       
# participants affected / at risk   1/204 (0.49%)   0/201 (0.00%)   0/108 (0.00%)   0/204 (0.00%)   0/232 (0.00%)   0/222 (0.00%)   0/59 (0.00%)   0/204 (0.00%)   0/260 (0.00%)   0/253 (0.00%)   0/204 (0.00%) 
Urinary tract infection * 1                       
# participants affected / at risk   0/204 (0.00%)   1/201 (0.50%)   0/108 (0.00%)   0/204 (0.00%)   0/232 (0.00%)   0/222 (0.00%)   0/59 (0.00%)   0/204 (0.00%)   0/260 (0.00%)   0/253 (0.00%)   0/204 (0.00%) 
Breast abscess * 1                       
# participants affected / at risk   0/204 (0.00%)   0/201 (0.00%)   0/108 (0.00%)   0/204 (0.00%)   0/232 (0.00%)   0/222 (0.00%)   0/59 (0.00%)   1/204 (0.49%)   0/260 (0.00%)   0/253 (0.00%)   0/204 (0.00%) 
Clostridial infection * 1                       
# participants affected / at risk   0/204 (0.00%)   0/201 (0.00%)   0/108 (0.00%)   0/204 (0.00%)   0/232 (0.00%)   1/222 (0.45%)   0/59 (0.00%)   0/204 (0.00%)   0/260 (0.00%)   0/253 (0.00%)   0/204 (0.00%) 
Erysipelas * 1                       
# participants affected / at risk   0/204 (0.00%)   0/201 (0.00%)   0/108 (0.00%)   0/204 (0.00%)   0/232 (0.00%)   0/222 (0.00%)   0/59 (0.00%)   1/204 (0.49%)   0/260 (0.00%)   0/253 (0.00%)   0/204 (0.00%) 
Gallbladder empyema * 1                       
# participants affected / at risk   0/204 (0.00%)   0/201 (0.00%)   0/108 (0.00%)   0/204 (0.00%)   0/232 (0.00%)   0/222 (0.00%)   0/59 (0.00%)   1/204 (0.49%)   0/260 (0.00%)   0/253 (0.00%)   0/204 (0.00%) 
Gastroenteritis * 1                       
# participants affected / at risk   0/204 (0.00%)   0/201 (0.00%)   0/108 (0.00%)   0/204 (0.00%)   1/232 (0.43%)   0/222 (0.00%)   0/59 (0.00%)   0/204 (0.00%)   0/260 (0.00%)   0/253 (0.00%)   0/204 (0.00%) 
Localised infection * 1                       
# participants affected / at risk   0/204 (0.00%)   0/201 (0.00%)   0/108 (0.00%)   0/204 (0.00%)   1/232 (0.43%)   0/222 (0.00%)   0/59 (0.00%)   0/204 (0.00%)   0/260 (0.00%)   0/253 (0.00%)   0/204 (0.00%) 
Septic shock * 1                       
# participants affected / at risk   0/204 (0.00%)   0/201 (0.00%)   0/108 (0.00%)   0/204 (0.00%)   1/232 (0.43%)   0/222 (0.00%)   0/59 (0.00%)   0/204 (0.00%)   0/260 (0.00%)   0/253 (0.00%)   0/204 (0.00%) 
Lung abscess * 1                       
# participants affected / at risk   0/204 (0.00%)   0/201 (0.00%)   0/108 (0.00%)   0/204 (0.00%)   0/232 (0.00%)   0/222 (0.00%)   0/59 (0.00%)   0/204 (0.00%)   1/260 (0.38%)   0/253 (0.00%)   0/204 (0.00%) 
Pneumonia * 1                       
# participants affected / at risk   0/204 (0.00%)   0/201 (0.00%)   0/108 (0.00%)   0/204 (0.00%)   0/232 (0.00%)   0/222 (0.00%)   0/59 (0.00%)   0/204 (0.00%)   1/260 (0.38%)   1/253 (0.40%)   0/204 (0.00%) 
Pulmonary tuberculosis * 1                       
# participants affected / at risk   0/204 (0.00%)   0/201 (0.00%)   0/108 (0.00%)   0/204 (0.00%)   0/232 (0.00%)   0/222 (0.00%)   0/59 (0.00%)   0/204 (0.00%)   0/260 (0.00%)   2/253 (0.79%)   0/204 (0.00%) 
Salpingo-oophoritis * 1                       
# participants affected / at risk   0/204 (0.00%)   0/201 (0.00%)   0/108 (0.00%)   0/204 (0.00%)   0/232 (0.00%)   0/222 (0.00%)   0/59 (0.00%)   0/204 (0.00%)   1/260 (0.38%)   0/253 (0.00%)   0/204 (0.00%) 
Injury, poisoning and procedural complications                       
Fall * 1                       
# participants affected / at risk   0/204 (0.00%)   1/201 (0.50%)   0/108 (0.00%)   0/204 (0.00%)   0/232 (0.00%)   0/222 (0.00%)   0/59 (0.00%)   0/204 (0.00%)   0/260 (0.00%)   0/253 (0.00%)   0/204 (0.00%) 
Femur fracture * 1                       
# participants affected / at risk   0/204 (0.00%)   1/201 (0.50%)   0/108 (0.00%)   1/204 (0.49%)   0/232 (0.00%)   0/222 (0.00%)   0/59 (0.00%)   0/204 (0.00%)   1/260 (0.38%)   0/253 (0.00%)   0/204 (0.00%) 
Humerus fracture * 1                       
# participants affected / at risk   1/204 (0.49%)   0/201 (0.00%)   0/108 (0.00%)   0/204 (0.00%)   1/232 (0.43%)   0/222 (0.00%)   0/59 (0.00%)   0/204 (0.00%)   0/260 (0.00%)   0/253 (0.00%)   0/204 (0.00%) 
Fibula fracture * 1                       
# participants affected / at risk   0/204 (0.00%)   0/201 (0.00%)   0/108 (0.00%)   0/204 (0.00%)   1/232 (0.43%)   0/222 (0.00%)   0/59 (0.00%)   0/204 (0.00%)   0/260 (0.00%)   1/253 (0.40%)   0/204 (0.00%) 
Scapula fracture * 1                       
# participants affected / at risk   0/204 (0.00%)   0/201 (0.00%)   0/108 (0.00%)   0/204 (0.00%)   1/232 (0.43%)   0/222 (0.00%)   0/59 (0.00%)   0/204 (0.00%)   0/260 (0.00%)   0/253 (0.00%)   0/204 (0.00%) 
Tendon rupture * 1                       
# participants affected / at risk   0/204 (0.00%)   0/201 (0.00%)   0/108 (0.00%)   0/204 (0.00%)   0/232 (0.00%)   1/222 (0.45%)   0/59 (0.00%)   0/204 (0.00%)   1/260 (0.38%)   0/253 (0.00%)   0/204 (0.00%) 
Joint dislocation * 1                       
# participants affected / at risk   0/204 (0.00%)   0/201 (0.00%)   0/108 (0.00%)   0/204 (0.00%)   0/232 (0.00%)   0/222 (0.00%)   0/59 (0.00%)   0/204 (0.00%)   0/260 (0.00%)   0/253 (0.00%)   1/204 (0.49%) 
Lower limb fracture * 1                       
# participants affected / at risk   0/204 (0.00%)   0/201 (0.00%)   0/108 (0.00%)   0/204 (0.00%)   0/232 (0.00%)   0/222 (0.00%)   0/59 (0.00%)   0/204 (0.00%)   1/260 (0.38%)   0/253 (0.00%)   0/204 (0.00%) 
Tibia fracture * 1                       
# participants affected / at risk   0/204 (0.00%)   0/201 (0.00%)   0/108 (0.00%)   0/204 (0.00%)   2/232 (0.86%)   0/222 (0.00%)   0/59 (0.00%)   0/204 (0.00%)   0/260 (0.00%)   0/253 (0.00%)   0/204 (0.00%) 
Metabolism and nutrition disorders                       
Diabetes mellitus * 1                       
# participants affected / at risk   1/204 (0.49%)   0/201 (0.00%)   0/108 (0.00%)   0/204 (0.00%)   0/232 (0.00%)   0/222 (0.00%)   0/59 (0.00%)   0/204 (0.00%)   0/260 (0.00%)   0/253 (0.00%)   0/204 (0.00%) 
Musculoskeletal and connective tissue disorders                       
Spinal column stenosis * 1                       
# participants affected / at risk   0/204 (0.00%)   1/201 (0.50%)   0/108 (0.00%)   0/204 (0.00%)   0/232 (0.00%)   0/222 (0.00%)   0/59 (0.00%)   0/204 (0.00%)   0/260 (0.00%)   0/253 (0.00%)   0/204 (0.00%) 
Tendon disorder * 1                       
# participants affected / at risk   1/204 (0.49%)   0/201 (0.00%)   0/108 (0.00%)   0/204 (0.00%)   0/232 (0.00%)   0/222 (0.00%)   0/59 (0.00%)   0/204 (0.00%)   0/260 (0.00%)   0/253 (0.00%)   0/204 (0.00%) 
Rheumatoid arthritis * 1                       
# participants affected / at risk   0/204 (0.00%)   0/201 (0.00%)   0/108 (0.00%)   0/204 (0.00%)   0/232 (0.00%)   1/222 (0.45%)   0/59 (0.00%)   0/204 (0.00%)   0/260 (0.00%)   0/253 (0.00%)   1/204 (0.49%) 
Spondylolisthesis * 1                       
# participants affected / at risk   0/204 (0.00%)   0/201 (0.00%)   0/108 (0.00%)   0/204 (0.00%)   0/232 (0.00%)   0/222 (0.00%)   0/59 (0.00%)   1/204 (0.49%)   0/260 (0.00%)   0/253 (0.00%)   0/204 (0.00%) 
Bursitis * 1                       
# participants affected / at risk   0/204 (0.00%)   0/201 (0.00%)   0/108 (0.00%)   0/204 (0.00%)   0/232 (0.00%)   0/222 (0.00%)   0/59 (0.00%)   0/204 (0.00%)   0/260 (0.00%)   0/253 (0.00%)   1/204 (0.49%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)                       
Hair follicle tumour benign * 1                       
# participants affected / at risk   1/204 (0.49%)   0/201 (0.00%)   0/108 (0.00%)   0/204 (0.00%)   0/232 (0.00%)   0/222 (0.00%)   0/59 (0.00%)   0/204 (0.00%)   0/260 (0.00%)   0/253 (0.00%)   0/204 (0.00%) 
Metastatic renal cell carcinoma * 1                       
# participants affected / at risk   1/204 (0.49%)   0/201 (0.00%)   0/108 (0.00%)   0/204 (0.00%)   0/232 (0.00%)   0/222 (0.00%)   0/59 (0.00%)   0/204 (0.00%)   0/260 (0.00%)   0/253 (0.00%)   0/204 (0.00%) 
Ovarian germ cell teratoma benign * 1                       
# participants affected / at risk   0/204 (0.00%)   1/201 (0.50%)   0/108 (0.00%)   0/204 (0.00%)   0/232 (0.00%)   0/222 (0.00%)   0/59 (0.00%)   0/204 (0.00%)   0/260 (0.00%)   0/253 (0.00%)   0/204 (0.00%) 
Benign salivary gland neoplasm * 1                       
# participants affected / at risk   0/204 (0.00%)   0/201 (0.00%)   0/108 (0.00%)   0/204 (0.00%)   1/232 (0.43%)   0/222 (0.00%)   0/59 (0.00%)   0/204 (0.00%)   0/260 (0.00%)   0/253 (0.00%)   0/204 (0.00%) 
Cervix carcinoma * 1                       
# participants affected / at risk   0/204 (0.00%)   0/201 (0.00%)   0/108 (0.00%)   0/204 (0.00%)   0/232 (0.00%)   1/222 (0.45%)   0/59 (0.00%)   0/204 (0.00%)   0/260 (0.00%)   0/253 (0.00%)   0/204 (0.00%) 
Cholesteatoma * 1                       
# participants affected / at risk   0/204 (0.00%)   0/201 (0.00%)   0/108 (0.00%)   0/204 (0.00%)   0/232 (0.00%)   1/222 (0.45%)   0/59 (0.00%)   0/204 (0.00%)   0/260 (0.00%)   0/253 (0.00%)   0/204 (0.00%) 
Myelodysplastic syndrome * 1                       
# participants affected / at risk   0/204 (0.00%)   0/201 (0.00%)   0/108 (0.00%)   0/204 (0.00%)   0/232 (0.00%)   0/222 (0.00%)   0/59 (0.00%)   1/204 (0.49%)   0/260 (0.00%)   0/253 (0.00%)   0/204 (0.00%) 
Neuroma * 1                       
# participants affected / at risk   0/204 (0.00%)   0/201 (0.00%)   0/108 (0.00%)   0/204 (0.00%)   0/232 (0.00%)   0/222 (0.00%)   0/59 (0.00%)   0/204 (0.00%)   0/260 (0.00%)   1/253 (0.40%)   0/204 (0.00%) 
Non-small cell lung cancer * 1                       
# participants affected / at risk   0/204 (0.00%)   0/201 (0.00%)   0/108 (0.00%)   0/204 (0.00%)   0/232 (0.00%)   0/222 (0.00%)   0/59 (0.00%)   0/204 (0.00%)   1/260 (0.38%)   0/253 (0.00%)   1/204 (0.49%) 
Nervous system disorders                       
Dysarthria * 1                       
# participants affected / at risk   0/204 (0.00%)   0/201 (0.00%)   1/108 (0.93%)   0/204 (0.00%)   0/232 (0.00%)   0/222 (0.00%)   0/59 (0.00%)   0/204 (0.00%)   0/260 (0.00%)   0/253 (0.00%)   0/204 (0.00%) 
Ischaemic stroke * 1                       
# participants affected / at risk   0/204 (0.00%)   0/201 (0.00%)   0/108 (0.00%)   0/204 (0.00%)   0/232 (0.00%)   0/222 (0.00%)   1/59 (1.69%)   0/204 (0.00%)   0/260 (0.00%)   0/253 (0.00%)   0/204 (0.00%) 
Headache * 1                       
# participants affected / at risk   0/204 (0.00%)   0/201 (0.00%)   0/108 (0.00%)   0/204 (0.00%)   0/232 (0.00%)   0/222 (0.00%)   0/59 (0.00%)   0/204 (0.00%)   0/260 (0.00%)   1/253 (0.40%)   0/204 (0.00%) 
Renal and urinary disorders                       
IgA nephropathy * 1                       
# participants affected / at risk   0/204 (0.00%)   0/201 (0.00%)   0/108 (0.00%)   1/204 (0.49%)   0/232 (0.00%)   0/222 (0.00%)   0/59 (0.00%)   0/204 (0.00%)   0/260 (0.00%)   0/253 (0.00%)   0/204 (0.00%) 
Renal failure acute * 1                       
# participants affected / at risk   0/204 (0.00%)   0/201 (0.00%)   0/108 (0.00%)   0/204 (0.00%)   0/232 (0.00%)   0/222 (0.00%)   0/59 (0.00%)   0/204 (0.00%)   0/260 (0.00%)   1/253 (0.40%)   0/204 (0.00%) 
Reproductive system and breast disorders                       
Cervix disorder * 1                       
# participants affected / at risk   0/204 (0.00%)   0/201 (0.00%)   0/108 (0.00%)   0/204 (0.00%)   1/232 (0.43%)   0/222 (0.00%)   0/59 (0.00%)   0/204 (0.00%)   0/260 (0.00%)   0/253 (0.00%)   0/204 (0.00%) 
Ovarian cyst * 1                       
# participants affected / at risk   0/204 (0.00%)   0/201 (0.00%)   0/108 (0.00%)   0/204 (0.00%)   0/232 (0.00%)   0/222 (0.00%)   1/59 (1.69%)   0/204 (0.00%)   0/260 (0.00%)   0/253 (0.00%)   0/204 (0.00%) 
Ovarian torsion * 1                       
# participants affected / at risk   0/204 (0.00%)   0/201 (0.00%)   0/108 (0.00%)   0/204 (0.00%)   1/232 (0.43%)   0/222 (0.00%)   0/59 (0.00%)   0/204 (0.00%)   0/260 (0.00%)   0/253 (0.00%)   0/204 (0.00%) 
Metrorrhagia * 1                       
# participants affected / at risk   0/204 (0.00%)   0/201 (0.00%)   0/108 (0.00%)   0/204 (0.00%)   0/232 (0.00%)   0/222 (0.00%)   0/59 (0.00%)   0/204 (0.00%)   1/260 (0.38%)   0/253 (0.00%)   0/204 (0.00%) 
Respiratory, thoracic and mediastinal disorders                       
Chronic obstructive pulmonary disease * 1                       
# participants affected / at risk   1/204 (0.49%)   0/201 (0.00%)   0/108 (0.00%)   0/204 (0.00%)   0/232 (0.00%)   0/222 (0.00%)   0/59 (0.00%)   0/204 (0.00%)   0/260 (0.00%)   0/253 (0.00%)   0/204 (0.00%) 
Hydrothorax * 1                       
# participants affected / at risk   0/204 (0.00%)   0/201 (0.00%)   0/108 (0.00%)   1/204 (0.49%)   0/232 (0.00%)   0/222 (0.00%)   0/59 (0.00%)   0/204 (0.00%)   0/260 (0.00%)   0/253 (0.00%)   0/204 (0.00%) 
Pleuritic pain * 1                       
# participants affected / at risk   1/204 (0.49%)   0/201 (0.00%)   0/108 (0.00%)   0/204 (0.00%)   0/232 (0.00%)   0/222 (0.00%)   0/59 (0.00%)   0/204 (0.00%)   0/260 (0.00%)   0/253 (0.00%)   0/204 (0.00%) 
Interstitial lung disease * 1                       
# participants affected / at risk   0/204 (0.00%)   0/201 (0.00%)   0/108 (0.00%)   0/204 (0.00%)   0/232 (0.00%)   0/222 (0.00%)   0/59 (0.00%)   0/204 (0.00%)   0/260 (0.00%)   1/253 (0.40%)   0/204 (0.00%) 
Pulmonary sarcoidosis * 1                       
# participants affected / at risk   0/204 (0.00%)   0/201 (0.00%)   0/108 (0.00%)   0/204 (0.00%)   0/232 (0.00%)   0/222 (0.00%)   0/59 (0.00%)   0/204 (0.00%)   1/260 (0.38%)   0/253 (0.00%)   0/204 (0.00%) 
Skin and subcutaneous tissue disorders                       
Prurigo * 1                       
# participants affected / at risk   1/204 (0.49%)   0/201 (0.00%)   0/108 (0.00%)   0/204 (0.00%)   0/232 (0.00%)   0/222 (0.00%)   0/59 (0.00%)   0/204 (0.00%)   0/260 (0.00%)   0/253 (0.00%)   0/204 (0.00%) 
Surgical and medical procedures                       
Cholecystectomy * 1                       
# participants affected / at risk   0/204 (0.00%)   0/201 (0.00%)   0/108 (0.00%)   0/204 (0.00%)   0/232 (0.00%)   0/222 (0.00%)   0/59 (0.00%)   0/204 (0.00%)   0/260 (0.00%)   1/253 (0.40%)   0/204 (0.00%) 
Vascular disorders                       
Hypertension * 1                       
# participants affected / at risk   0/204 (0.00%)   1/201 (0.50%)   0/108 (0.00%)   0/204 (0.00%)   0/232 (0.00%)   0/222 (0.00%)   0/59 (0.00%)   0/204 (0.00%)   0/260 (0.00%)   0/253 (0.00%)   0/204 (0.00%) 
Venous thrombosis limb * 1                       
# participants affected / at risk   0/204 (0.00%)   1/201 (0.50%)   0/108 (0.00%)   0/204 (0.00%)   0/232 (0.00%)   0/222 (0.00%)   0/59 (0.00%)   0/204 (0.00%)   0/260 (0.00%)   0/253 (0.00%)   0/204 (0.00%) 
* Events were collected by non-systematic assessment
1 Term from vocabulary, MedDRAv13.1




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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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