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Study Title and Description

Tension-free vaginal tape versus colposuspension for primary urodynamic stress incontinence: 5-year follow up.



Key Questions Addressed
1 Sling vs Comparator RCT outcomes (excluding AEs)
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2 Sling Adverse Events
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Primary Publication Information
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TitleData
Title Tension-free vaginal tape versus colposuspension for primary urodynamic stress incontinence: 5-year follow up.
Author Ward, HIlton for UK and Ireland TVT Trial Gro
Country --
Year 2008
Numbers Pubmed ID: 17970791
13 (internal)

Secondary Publication Information
UI Title Author Country Year
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Extraction Form: Sling Adverse Events
Arms
Number Title Description Comments
1 Retropubic synthetic TVT: performed as described by Ulmstem: under local anesthesia and sedation; did not place foley after surgery unless there was cystotomy from trocars- these patients had foley for 48 hours
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2 Burch Colposuspension: via "standard technique for the units"
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Design Details
Question... Follow Up Answer Follow-up Answer
Study Type RCT
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Study Name TVT Trial Group
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Study Country UK
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Other ... Ireland
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Sling Category Retropubic synthetic
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Multicenter? Yes
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Institution Type Academic hospital
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Community hospital
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No. of Surgeons Performing the Procedures ... Other ... 16
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Surgeons' Training Urology
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General
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Other ... departments of gynecology and urology
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Residents or Fellows Performing the Surgery? Yes
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Adverse Event Ascertainment Active
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Unclear/Not reported
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Was the Clavien-Dindo Classification of Surgical Complications system used? No / Not reported
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Was a data safety monitoring board used? No / Not reported
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Study Sponsor/Funding Industry
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Other ... Ethicon
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Results & Comparisons


Results Data
Outcome: SUI subjective-BFLUTS      Population: 8971
Time Point Measure TVT Burch Retropubic synthetic Burch


5 years

N Analyzed 168 154
Mean 100 % 100%
Standard Deviation


0 years

N Analyzed 128 102
Mean 40 % 38%
Standard Deviation


2 years

N Analyzed 98 79
Mean 51 % 46 %
Standard Deviation
Statistical Test: Odds Ratio (OR) Standard Deviation Statistical Test: Odds Ratio (OR) Standard Deviation P-Value Statistical Test: Odds Ratio (OR) Standard Deviation P-Value
Outcome: UUI subjective-daytime frequency BFLUTS%-5yr      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Burch Retropubic synthetic Burch Comparison Measure TVT vs. Burch


0 years

N Analyzed 168 155
Mean 80% 79%
Standard Deviation


5 years

N Analyzed 98 79
Mean 47% 44%
Standard Deviation
.63


2 years

N Analyzed 128 102
Mean 46% 49%
Standard Deviation
.72
Outcome: QOL-BFLUTS fluid restriction      Population: 8974
Time Point Measure TVT Burch Retropubic synthetic Burch


5 years

N Enrolled 98 79
Counts 39% 32%
Standard Deviation


0 years

N Enrolled 168 155
Counts 72% 71%
Standard Deviation


2 years

N Enrolled 128 102
Counts 34% 32%
Standard Deviation
Outcome: QOL-BFLUTS Ability to perform daily tasks      Population: 8975
Time Point Measure TVT Burch Retropubic synthetic Burch


0 years

N Enrolled 168 155
Counts 81% 81%
Standard Deviation


5 years

N Enrolled 98 79
Counts 14% 14%
Standard Deviation


2 years

N Enrolled 128 102
Counts 13% 19%
Standard Deviation
Outcome: QOL-BFLUTS Avoiding places or situations      Population: 8976
Time Point Measure TVT Burch Retropubic synthetic Burch


5 years

N Enrolled 98 79
Counts 37% 28%
Standard Deviation


0 years

N Enrolled 168 155
Counts 73% 73%
Standard Deviation


2 years

N Enrolled 128 102
Counts 25% 26%
Standard Deviation
Outcome: QOL-BFLUTS Interfering with physical activity      Population: 8978
Time Point Measure TVT Burch Retropubic synthetic Burch


0 years

N Enrolled 168 155
Counts 95% 93%
Standard Deviation


5 years

N Enrolled 98 79
Counts 18% 18%
Standard Deviation


2 years

N Enrolled 128 102
Counts 14% 19%
Standard Deviation
Outcome: QOL-BFLUTS Interfering with social relationships      Population: 8979
Time Point Measure TVT Burch Retropubic synthetic Burch


5 years

N Enrolled 98 79
Counts 13% 14%
Standard Deviation


0 years

N Enrolled 168 155
Counts 72% 76%
Standard Deviation


2 years

N Enrolled 128 102
Counts 9% 12%
Standard Deviation
Outcome: QOL-BFLUTS Interfering with life overall      Population: 8980
Time Point Measure TVT Burch Retropubic synthetic Burch


0 years

N Enrolled 168 155
Counts 98% 94%
Standard Deviation


5 years

N Enrolled 98 79
Counts 31% 24%
Standard Deviation


2 years

N Enrolled 128 102
Counts 20% 25%
Standard Deviation
Outcome: Sexual function-BFLUTS Pain due to dry vagina      Population: 9015
Time Point Measure TVT Burch Retropubic synthetic Burch


0 years

N Enrolled 168 155
Counts 34% 39%
Standard Deviation


5 years

N Enrolled 98 79
Counts 28% 32%
Standard Deviation


2 years

N Enrolled 128 102
Counts 35% 33%
Standard Deviation
Outcome: Sexual function-BFLUTS Sex life spoilt by symptoms      Population: 9016
Time Point Measure TVT Burch Retropubic synthetic Burch


5 years

N Enrolled 98 79
Counts 18% 15%
Standard Deviation


0 years

N Enrolled 168 155
Counts 72% 62%
Standard Deviation


2 years

N Enrolled 128 102
Counts 22% 23%
Standard Deviation
Outcome: Sexual function-BFLUTS Pain with intercourse      Population: 9017
Time Point Measure TVT Burch Retropubic synthetic Burch


0 years

N Enrolled 168 155
Counts 35% 32%
Standard Deviation


5 years

N Enrolled 98 79
Counts 15% 22%
Standard Deviation


2 years

N Enrolled 128 102
Counts 25% 33%
Standard Deviation
Outcome: Sexual function-BFLUTS Incontinence with intercourse      Population: 9018
Time Point Measure TVT Burch Retropubic synthetic Burch


5 years

N Enrolled 98 79
Counts 6% 9%
Standard Deviation


0 years

N Enrolled 168 155
Counts 60% 62%
Standard Deviation


2 years

N Enrolled 128 102
Counts 16% 22%
Standard Deviation
Outcome: SUI objective-pad test <1g      Population: 9025
Time Point Measure TVT Burch Retropubic synthetic Burch


2 years

N Enrolled 137 108
Counts 111 86
Standard Deviation


0 years

N Enrolled 168 154
Counts
Standard Deviation


5 years

N Enrolled 72 49
Counts 58 44
Standard Deviation
Statistical Test: Odds Ratio (OR) Standard Deviation P-Value Statistical Test: Odds Ratio (OR) Standard Deviation Statistical Test: Odds Ratio (OR) Standard Deviation P-Value
Outcome: UUI subjective-nighttime frequency BFLUTS%-5yr      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Burch Retropubic synthetic Burch Comparison Measure TVT vs. Burch


5 years

N Enrolled 98 79
Counts 65 81
Standard Deviation
.47


0 years

N Enrolled 168 155
Counts 80% 83%
Standard Deviation


2 years

N Enrolled 128 102
Counts 63% 66%
Standard Deviation
.48
Statistical Test: Odds Ratio (OR) Standard Deviation P-Value Statistical Test: Odds Ratio (OR) Standard Deviation Statistical Test: Odds Ratio (OR) Standard Deviation P-Value
Outcome: UUI subjective-urgency BFLUTS%-5yr      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Burch Retropubic synthetic Burch Comparison Measure TVT vs. Burch


2 years

N Enrolled 128 102
Counts 76 79
Standard Deviation
.36


0 years

N Enrolled 168 155
Counts 95 93
Standard Deviation


5 years

N Enrolled 98 79
Counts 86 77
Standard Deviation
.40
Statistical Test: Odds Ratio (OR) Standard Deviation P-Value Statistical Test: Odds Ratio (OR) Standard Deviation Statistical Test: Odds Ratio (OR) Standard Deviation P-Value
Outcome: UUI subjective-urge incontinence BFLUTS%-5yr      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Burch Retropubic synthetic Burch Comparison Measure TVT vs. Burch


5 years

N Enrolled 98 79
Counts 71 68
Standard Deviation


0 years

N Enrolled 168 155
Counts 95 95
Standard Deviation .72


2 years

N Enrolled 128 102
Counts 52 61
Standard Deviation
.03
Outcome: SUI objective-pad test      Population: 8970
Time Point Measure TVT Burch Retropubic synthetic Burch


0 years

N Analyzed 168 154
Mean 18 16
Standard Deviation


5 years

N Analyzed 72 49
Mean 0 0
Standard Deviation


2 years

N Analyzed 137 108
Mean 0 0
Standard Deviation
Outcome: QOL-SF36 Physical function      Population: 8981
Time Point Measure TVT Burch Retropubic synthetic Burch


5 years

N Analyzed 90 69
Mean 15.6 16.1
Standard Deviation


0 years

N Analyzed 166 141
Mean 66.5 66.4
Standard Deviation


2 years

N Analyzed 128 102
Mean 17.2 15
Standard Deviation
Outcome: QOL-SF36 Role Physical      Population: 9005
Time Point Measure TVT Burch Retropubic synthetic Burch


5 years

N Analyzed 90 69
Mean 10.7 10.8
Standard Deviation


0 years

N Analyzed 166 141
Mean 68 64.2
Standard Deviation


2 years

N Analyzed 128 102
Mean 13.2 9.5
Standard Deviation
N Enrolled Mean Difference Standard Deviation P-Value Enter a Title Here N Enrolled Mean Difference Standard Deviation P-Value Enter a Title Here N Enrolled Mean Difference Standard Deviation P-Value Enter a Title Here
Outcome: QOL-SF36 Role emotional      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Burch Retropubic synthetic Burch Comparison Measure TVT vs. Burch


0 years

N Analyzed 166 141
Mean 70.1 72.8
Standard Deviation


5 years

N Analyzed 90 69
Mean 13.6 9.8
Standard Deviation
.55


2 years

N Analyzed 128 102
Mean 10.1 1.4
Standard Deviation
.028
Outcome: QOL-SF36 Social functioning      Population: 9008
Time Point Measure TVT Burch Retropubic synthetic Burch


5 years

N Analyzed 90 69
Mean 11.2 8
Standard Deviation


0 years

N Analyzed 166 141
Mean 74.5 77
Standard Deviation


2 years

N Analyzed 128 102
Mean 12.2 5.7
Standard Deviation
Outcome: QOL-SF36 Mental Health      Population: 9011
Time Point Measure TVT Burch Retropubic synthetic Burch


5 years

N Analyzed 90 69
Mean 8.7 8
Standard Deviation


0 years

N Analyzed 166 141
Mean 66 67.4
Standard Deviation


2 years

N Analyzed 128 102
Mean 7.3 1.5
Standard Deviation
Outcome: QOL-SF36 Energy/vitality      Population: 9012
Time Point Measure TVT Burch Retropubic synthetic Burch


5 years

N Analyzed 90 69
Mean 8.2 8.2
Standard Deviation


0 years

N Analyzed 166 141
Mean 51.6 53
Standard Deviation


2 years

N Analyzed 128 102
Mean 7.1 4.2
Standard Deviation
Outcome: QOL-SF36 Pain      Population: 9013
Time Point Measure TVT Burch Retropubic synthetic Burch


0 years

N Analyzed 166 141
Mean 75.4 7.6
Standard Deviation


5 years

N Analyzed 90 69
Mean -- --
Standard Deviation


2 years

N Analyzed 128 102
Mean .5 2
Standard Deviation
Outcome: QOL-SF36 General health      Population: 9014
Time Point Measure TVT Burch Retropubic synthetic Burch


5 years

N Analyzed 90 69
Mean 3.6 4.2
Standard Deviation


0 years

N Analyzed 166 141
Mean 69.9 69.3
Standard Deviation


2 years

N Analyzed 128 102
Mean
Standard Deviation 1.2 1
N Enrolled Mean Difference Standard Deviation P-Value Enter a Title Here N Enrolled Mean Difference Standard Deviation P-Value Enter a Title Here
Outcome: EBL      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Burch Retropubic synthetic Burch Comparison Measure TVT vs. Burch


0 years

N Analyzed 170 146
Mean 50 128
Standard Deviation
<.001


5 years

N Analyzed
Mean
Standard Deviation
N Enrolled Mean Difference Standard Deviation P-Value Enter a Title Here N Enrolled Mean Difference Standard Deviation P-Value Enter a Title Here
Outcome: Time in OR      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Burch Retropubic synthetic Burch Comparison Measure TVT vs. Burch


5 years

N Analyzed
Mean
Standard Deviation


0 years

N Analyzed 170 146
Mean 40 50
Standard Deviation
<.001
N Enrolled Mean Difference Standard Deviation P-Value Enter a Title Here N Enrolled Mean Difference Standard Deviation P-Value Enter a Title Here
Outcome: Time in hospital      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Burch Retropubic synthetic Burch Comparison Measure TVT vs. Burch


0 years

N Analyzed 170 146
Mean 1 5
Standard Deviation
<.001


5 years

N Analyzed
Mean
Standard Deviation
Outcome: Retreatment for SUI      Population: 9024
Time Point Measure TVT Burch Retropubic synthetic Burch


5 years

N Analyzed 170 146
Mean 4 5
Standard Deviation


0 years

N Analyzed
Mean
Standard Deviation


2 years

N Analyzed 170 146
Mean 3 5
Standard Deviation
N Enrolled Mean Difference Standard Deviation P-Value Enter a Title Here N Enrolled Mean Difference Standard Deviation P-Value Enter a Title Here N Enrolled Mean Difference Standard Deviation P-Value Enter a Title Here
Outcome: Time to return to normal activities      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Burch Retropubic synthetic Burch Comparison Measure TVT vs. Burch


2 years

N Analyzed
Mean
Standard Deviation


0 years

N Analyzed 170 146
Mean 3 6
Standard Deviation
<.001


5 years

N Analyzed
Mean
Standard Deviation
N Enrolled Mean Difference Standard Deviation P-Value Enter a Title Here N Enrolled Mean Difference Standard Deviation P-Value Enter a Title Here N Enrolled Mean Difference Standard Deviation P-Value Enter a Title Here
Outcome: Time to return to work      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Burch Retropubic synthetic Burch Comparison Measure TVT vs. Burch


5 years

N Analyzed
Mean
Standard Deviation


0 years

N Analyzed 170 146
Mean 4 10
Standard Deviation
<.001


2 years

N Analyzed
Mean
Standard Deviation

Adverse Events
Arm or Total Title Description Follow-up time In-hospital or After discharge Is event serious? Reported definition of serious event Number affected Number at risk (analyzed) Difference between 2 slings (eg, OR/RR or %, with 95% CI) Reported P value between slings Comments
Retropubic synthetic Mesh erosion/extrusion/exposure/granulation tissue Mesh exposure 5yr 4 170
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Burch 146
Total
Retropubic synthetic Return to OR For Prolapse surgery: TVH±SSLF TVH,colporrhaphy,±SSLF Post rep ±SSLF Ant/Post repair Incision hernia repair 5yr 3 170
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Burch 5yr 16 (5 incisional hernia repair) 146
Total 5yr p=.025
Retropubic synthetic Infection, UTI unclear up to 6 weeks 38 170
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Burch 46 146
Total
Retropubic synthetic Infection, surgical site/wound unclear up to 6 mo postop 4 170
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Burch 10 146
Total
Retropubic synthetic Obstruction requiring reoperation obstructed voiding 8 mo 1 170
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Burch 0 146
Total
Retropubic synthetic Organ injury in OR (urethra, bladder, bowel) bladder perforation or evidence of trauma 15 170
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Burch 3 146
Total
Retropubic synthetic Organ injury in OR (urethra, bladder, bowel) vaginal perforation 5 170
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Burch 0 146
Total
Retropubic synthetic Organ injury in OR (urethra, bladder, bowel) vascular injury 1 170
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Burch 0 146
Total
Retropubic synthetic DVT DVT/PE 0 170
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Burch 3 146
Total p=.10
Retropubic synthetic retention requiring catheter 1-7 days post op: SP, intermittent or urethral 1-7 days 62 170
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Burch 146 146
Total
Retropubic synthetic retention requiring catheter 8-28 days post op: SP, intermittent or urethral 8-28days 9 170
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Burch 48 146
Total p<.0001
Retropubic synthetic retention requiring catheter 29d-6mo post op: SP, intermittent or urethral 29d-6mo 5 170
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Burch 19 146
Total p<.001
Retropubic synthetic retention requiring catheter >6mo post op: SP, intermittent or urethral 5 170
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Burch 11 146
Total p=.0746
Retropubic synthetic retropubic hematoma not defined 3 170
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Burch 0 146
Total p=.25
Retropubic synthetic
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Burch
Total

Extraction Form: Sling vs Comparator RCT outcomes (excluding AEs)
Arms
Number Title Description Comments
1 TVT TVT: performed as described by Ulmstem: under local anesthesia and sedation; did not place foley after surgery unless there was cystotomy from trocars- these patients had foley for 48 hours
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2 Burch Colposuspension: via "standard technique for the units"
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Design Details
Question... Follow Up Answer Follow-up Answer
Country UK
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Other ... Ireland
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Population (reason for surgery etc.) Urodynamic SUI
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RCT Comparison Category Sling vs. Burch
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Multicenter Yes
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Institution Type Academic hospital
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Community hospital
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Number of surgeons performing procedures ... Other ... 16
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Surgeons' Training Urogynecology
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Urology
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General
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Other ... Gynecology and Urology Departments (likely includes urogyns)
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Residents or fellows performing surgery? Yes
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Study Quality (overall) B (fair)
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Study Sponsor/Funding Industry
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Other ... Ethicon
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Baseline Characteristics
Question TVT Burch Retropubic synthetic Burch Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up
No. Randomized 175 169 344
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Mean Age 50 50
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Post-Op Follow-Up Interval (Maximum) 5 yr 5 yr
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Results & Comparisons