Clinical trial NCT03429049
Conditions: Osteoarthritis, Knee
Keywords: analgesic non-opioid capsaicin intra-articular osteoarthritis pain knee pain
Sponsor: Centrexion Therapeutics
Start date: 2018-01-24; Completion date: 2019-11-22
Enrollment: 332 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a phase 3, randomized, double-blind, placebo-controlled, single injection, 52-week study to evaluate the analgesic efficacy and safety of a single intra-articular (IA) CNTX-4975-05 (capsaicin), compared to IA placebo, in subjects with chronic, moderate-to-severe osteoarthritis (OA) knee pain.

Detailed description:

Arms: arm 1: Matching placebo of 2.0 mL for IA injection arm 2: Pre-filled glass syringes administered as a single 2.0 mL IA injection
Interventions: intervention 1: CNTX-4975-05 intervention 2: Placebo
Intervention descriptions: intervention 1: Receiving CNTX-4975-05 injection intervention 2: Receiving Placebo injection

Protocol documents:
Prot_SAP_000.pdf: 




















































































































































































Centrexion Therapeutics Protocol CNTX-4975i-OA-301 
Hospital Anxiety & Depression Scale 
Centrexion 301 Study: HADS Assessment: Final V1.0—27-Sep-2017 
  
 
 
 
Subject No:  ____ ____ ____ ____   
                                 Subject Initials:  ____ ____ ____ 
 
 
 
 
                                    Day 
         Month 
           Year 
Date of Completion:  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Please sign your initials upon                              
completing the 
questionnaire on the back 
page 
Page 91 of 118
 
 


Hospital Anxiety and 
Depression Scale (HADS) 
Clinicians are aware that emotions play an important part in most illnesses. If your clinician knows about these 
feelings, he or she will be able to help you more. 
This questionnaire is designed to help your clinician to know how you feel. Read each item below and check the box 
which comes closest to how you have been feeling in the past week. 
Don’t take too long over your replies; your immediate reaction to each item will probably be more accurate than a 
long, thought-out response. 
I feel as if I am slowed down 
Nearly all the time ☐ 
Very often ☐ 
Sometimes ☐ 
Never ☐ 
 I get a sort of anxious feeling like "butterflies" in the 
stomach 
Never ☐ 
Occasionally ☐ 
Often ☐ 
Very often ☐ 
I have lost interest in my appearance 
Definitely ☐ 
Often I don't take as much care as I should ☐ 
Sometimes I don't take as much care as I should ☐ 
I take just as much care as ever ☐ 
I feel restless as if I have to be on the move 
Definitely ☐ 
Quite a lot ☐ 
Not very much ☐ 
Never ☐ 
I look forward with enjoyment to things 
As much as I ever have ☐ 
Somewhat less than I used to ☐ 
Much less than I used to ☐ 
Rarely ☐ 
I get sudden feelings of panic 
Very often ☐ 
Often ☐ 
Not very often ☐ 
Never ☐ 
I can enjoy a good book, radio or 
television program 
Often ☐ 
Sometimes ☐ 
Not often ☐ 
Very seldom ☐ 
I feel tense or "wound up" 
☐Most of the time
☐A lot of the time
☐From time to time, occasionally
☐Never
I enjoy the things I used to enjoy 
☐Definitely
☐Not quite so much
☐Only a little
☐Hardly at all
I get a sort of frightened feeling as if 
something awful is about to happen 
☐Very definitely and fairly badly
☐Yes, but not too badly
☐Sometimes, but it doesn’t worry me
☐Never
I can laugh and see the funny side of things 
☐As much as I always could
☐Not quite so much now
☐Definitely not so much now
☐Never
Worrying thoughts go through my mind 
☐A great deal of the time
☐A lot of the time
☐Not too often
☐Almost never
I feel cheerful 
☐Never
☐Not often
☐Sometimes
☐Most of the time
I can sit at ease and feel relaxed 
☐Always
☐Usually
☐Not often
☐Never
HADS copyright © R.P. Snaith and A.S. Zigmond, 1983, 1992, 1994. 
Record form items originally published in Acta Psychiatrica Scandinavica, 67, 361–70,  
copyright © Munksgaard International Publishers Ltd, Copenhagen, 1983. 
This edition first published in 1994 by nferNelson Publishing Company Ltd, now GL Assessment Limited, 
1st Floor Vantage London, Great West Road, Brentford TW8 9A, United Kingdom. 
GL Assessment is part of GL Education  www.gl-assessment.co.uk 
This form may not be reproduced by any means without first obtaining permission from the publisher. 
E-mail: permissions@gl-assessment.co.uk
All rights reserved including translations.
Page 92 of 118
 
 


Centrexion Therapeutics Protocol CNTX-4975i-OA-301 
Fibromyalgia Symptoms Scale 
Centrexion 301 Study: FSS Assessment: Final V1.0—27-Sep-2017 
Subject No:  ____ ____ ____ ____ 
 Subject Initials:  ____ ____ ____ 
 Day 
  Month 
  Year 
Date of Completion:  
Please sign your initials upon  
completing the 
questionnaire on the back 
page 
Page 93 of 118
 
 




WOMAC Osteoarthritis Index NRS3.1 
 
WOMAC NRS 3.1 – English for USA – V5  
Page 1 of 6 
 
INSTRUCTIONS TO PATIENTS 
 
In Sections A, B and C, questions will be asked in the following format and you 
should give your answers by putting an “ ” in one of the boxes. 
 
EXAMPLES: 
 
1. If you put your “ ”in the box on the far left as shown below, then you are 
indicating that you have no pain. 
 
No 
Pain 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
Extreme 
Pain 
 
 
 
2.  If you put your “  ”in the box on the far right as shown below, then you are 
indicating that you have extreme pain. 
 
No 
Pain 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
Extreme 
Pain 
 
 
 
3.  Please note: 
a)  that the further to the right you place your “  ” the more pain you feel. 
b)  that the further to the left you place your “  ” the less pain you feel. 
c)  please do not place your “  ”outside any of the boxes. 
 
You will be asked to indicate on this type of scale the amount of pain, stiffness 
or disability you have felt during the last 48 hours. 
 
Think about your ____________ (study joint) when answering the questionnaire.  
Indicate the severity of your pain and stiffness and the difficulty you have in 
doing daily activities that you feel are caused by the arthritis in your 
____________ (study joint). 
 
Your study joint has been identified for you by your health care professional.   
 
If you are unsure which joint is your study joint, please ask before completing 
the questionnaire. 
 
 
Copyright©1996 Nicholas Bellamy 
All Rights Reserved 
 
 
 
Page 95 of 118


WOMAC Osteoarthritis Index NRS3.1 
 
WOMAC NRS 3.1 – English for USA – V5  
Page 2 of 6 
 
Section A 
 
 
PAIN 
 
 
Think about the pain you felt in your ____________ (study joint) caused by the arthritis 
during the last 48 hours. 
 
(Please mark your answers by putting an “” in one of the boxes.) 
QUESTION: How much pain have you had  . . . 
 
1.  when walking on a flat surface? 
No 
Pain 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
Extreme 
Pain 
 
 
2.  when going up or down stairs? 
No 
Pain 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
Extreme 
Pain 
 
 
3.  at night while in bed? (that is - pain that disturbs your sleep) 
No 
Pain 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
Extreme 
Pain 
 
 
4.  while sitting or lying down? 
No 
Pain 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
Extreme 
Pain 
 
 
5.  while standing? 
No 
Pain 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
Extreme 
Pain 
 
 
 
Copyright©1996 Nicholas Bellamy 
All Rights Reserved 
Page 96 of 118


WOMAC Osteoarthritis Index NRS3.1 
 
WOMAC NRS 3.1 – English for USA – V5  
Page 3 of 6 
Section B 
 
 
STIFFNESS 
 
 
Think about the stiffness (not pain) you felt in your  ____________ (study joint) caused 
by the arthritis during the last 48 hours.  
 
Stiffness is a sensation of decreased ease in moving your joint. 
 
(Please mark your answers by putting an “” in one of the boxes.) 
 
6.  How severe has your stiffness been after you first woke up in the morning?  
No 
Stiffness 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
Extreme 
Stiffness 
 
 
7.  How severe has your stiffness been after sitting or lying down or  
while resting later in the day? 
No 
Stiffness 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
Extreme 
Stiffness 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Copyright©1996 Nicholas Bellamy 
All Rights Reserved 
Page 97 of 118


WOMAC Osteoarthritis Index NRS3.1 
 
WOMAC NRS 3.1 – English for USA – V5  
Page 4 of 6 
 
Section C 
 
 
DIFFICULTY PERFORMING DAILY ACTIVITIES 
 
 
Think about the difficulty you had in doing the following daily physical activities caused 
by the arthritis in your ____________ (study joint) during the last 48 hours. By this we 
mean your ability to move around and take care of yourself. 
 
(Please mark your answers by putting an “” in one of the boxes.) 
QUESTION: How much difficulty have you had  . . . 
 
8.  when going down the stairs? 
No 
Difficulty 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
Extreme 
Difficulty  
 
 
9.  when going up the stairs? 
No 
Difficulty 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
Extreme 
Difficulty  
 
 
10.  when getting up from a sitting position? 
No 
Difficulty 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
Extreme 
Difficulty  
 
 
11.  while standing? 
No 
Difficulty 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
Extreme 
Difficulty  
 
 
12.  when bending to the floor? 
No 
Difficulty 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
Extreme 
Difficulty  
 
 
13.  when walking on a flat surface? 
No 
Difficulty 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
Extreme 
Difficulty  
 
Copyright©1996 Nicholas Bellamy 
All Rights Reserved 
Page 98 of 118


WOMAC Osteoarthritis Index NRS3.1 
 
WOMAC NRS 3.1 – English for USA – V5  
Page 5 of 6 
 
 
 
DIFFICULTY PERFORMING DAILY ACTIVITIES 
 
 
Think about the difficulty you had in doing the following daily physical activities caused 
by the arthritis in your ____________ (study joint) during the last 48 hours. By this we 
mean your ability to move around and take care of yourself. 
 
(Please mark your answers by putting an “” in one of the boxes.) 
QUESTION: How much difficulty have you had  . . . 
 
14.  getting in or out of a car, or getting on or off a bus? 
No 
Difficulty 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
Extreme 
Difficulty  
 
 
15.  while going shopping? 
No 
Difficulty 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
Extreme 
Difficulty  
 
 
16.  when putting on your socks or panty hose or stockings? 
No 
Difficulty 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
Extreme 
Difficulty  
 
 
17.  when getting out of bed? 
No 
Difficulty 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
Extreme 
Difficulty  
 
 
18.  when taking off your socks or panty hose or stockings? 
No 
Difficulty 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
Extreme 
Difficulty  
 
 
19.  while lying in bed? 
No 
Difficulty 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
Extreme 
Difficulty  
 
Copyright©1996 Nicholas Bellamy 
All Rights Reserved 
Page 99 of 118


WOMAC Osteoarthritis Index NRS3.1 
 
WOMAC NRS 3.1 – English for USA – V5  
Page 6 of 6 
 
 
 
DIFFICULTY PERFORMING DAILY ACTIVITIES 
 
 
Think about the difficulty you had in doing the following daily physical activities caused 
by the arthritis in your ____________ (study joint) during the last 48 hours. By this we 
mean your ability to move around and take care of yourself. 
 
(Please mark your answers by putting an “” in one of the boxes.) 
QUESTION: How much difficulty have you had  . . . 
 
20.  when getting in or out of the bathtub? 
No 
Difficulty 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
Extreme 
Difficulty  
 
 
21.  while sitting? 
No 
Difficulty 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
Extreme 
Difficulty  
 
 
22.  when getting on or off the toilet? 
No 
Difficulty 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
Extreme 
Difficulty  
 
 
23.  while doing  heavy household chores? 
No 
Difficulty 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
Extreme 
Difficulty  
 
 
24.  while doing light household chores? 
No 
Difficulty 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
Extreme 
Difficulty  
 
 
 
 
Copyright©1996 Nicholas Bellamy 
All Rights Reserved 
Page 100 of 118










SF-36v2® Health Survey © 1992, 1996, 2000 Medical Outcomes Trust and QualityMetric Incorporated.  All rights reserved. 
SF-36® is a registered trademark of Medical Outcomes Trust. 
(SF-36v2® Health Survey Standard, United States (English)) 
Your Health and Well-Being 
This survey asks for your views about your health.  This information will help 
keep track of how you feel and how well you are able to do your usual activities. 
Thank you for completing this survey! 
For each of the following questions, please mark an 
 in the one box that best 
describes your answer. 
1.
In general, would you say your health is:
Excellent 
Very good 
Good
Fair
Poor





1
2
3
4
5
2.
Compared to one year ago, how would you rate your health in general
now? 
Much better 
now than one 
year ago 
Somewhat 
better  
now than one 
year ago 
About the 
same as  
one year ago 
Somewhat 
worse  
now than one 
year ago 
Much worse 
now than one 
year ago 





1
2
3
4
5
SF-36 Health Survey
Page 105 of 118


SF-36v2® Health Survey © 1992, 1996, 2000 Medical Outcomes Trust and QualityMetric Incorporated.  All rights reserved. 
SF-36® is a registered trademark of Medical Outcomes Trust. 
(SF-36v2® Health Survey Standard, United States (English)) 
3.
The following questions are about activities you might do during a typical
day.  Does your health now limit you in these activities?  If so, how much?
Yes,  
limited  
a lot 
Yes, 
limited  
a little 
No, not 
limited  
at all 



a
Vigorous activities, such as running, lifting  
heavy objects, participating in strenuous sports ...................... 
 1 ............. 
 2 ............. 
3
b
Moderate activities, such as moving a table, pushing  
a vacuum cleaner, bowling, or playing golf ............................ 
1 ............. 
 2 ............. 
3
c
Lifting or carrying groceries .................................................... 
 1 ............. 
 2 ............. 
3
d
Climbing several flights of stairs ............................................. 
 1 ............. 
 2 ............. 
3
e
Climbing one flight of stairs .................................................... 
 1 ............. 
 2 ............. 
3
f
Bending, kneeling, or stooping ................................................ 
 1 ............. 
 2 ............. 
3
g
Walking more than a mile ........................................................ 
 1 ............. 
 2 ............. 
3
h
Walking several hundred yards ............................................... 
 1 ............. 
 2 ............. 
3
i
Walking one hundred yards ..................................................... 
 1 ............. 
 2 ............. 
3
j
Bathing or dressing yourself .................................................... 
 1 ............. 
 2 ............. 
3
Page 106 of 118


SF-36v2® Health Survey © 1992, 1996, 2000 Medical Outcomes Trust and QualityMetric Incorporated.  All rights reserved. 
SF-36® is a registered trademark of Medical Outcomes Trust. 
(SF-36v2® Health Survey Standard, United States (English)) 
4.
During the past 4 weeks, how much of the time have you had any of the
following problems with your work or other regular daily activities as a
result of your physical health?
All of  
the time 
Most of 
the time 
Some of  
the time 
A little of 
the time 
None of 
the time 



 
a Cut down on the amount of  
time you spent on work or  
other activities ................................. 
 1 .............. 
 2 .............. 
 3 .............. 
 4 ............. 
5
b Accomplished less than you  
would like ........................................ 
 1 .............. 
 2 .............. 
 3 .............. 
 4 ............. 
5
 
c Were limited in the kind of  
work or other activities .................... 
 1 .............. 
 2 .............. 
 3 .............. 
 4 ............. 
5
 
d Had difficulty performing the  
work or other activities (for  
example, it took extra effort) ........... 
 1 .............. 
 2 .............. 
 3 .............. 
 4 ............. 
5
5.
During the past 4 weeks, how much of the time have you had any of the
following problems with your work or other regular daily activities as a
result of any emotional problems (such as feeling depressed or anxious)?
All of  
the time 
Most of 
the time 
Some of  
the time 
A little of 
the time 
None of 
the time 



 
a Cut down on the amount of  
time you spent on work or  
other activities ................................. 
 1 .............. 
 2 .............. 
 3 .............. 
 4 ............. 
5
b Accomplished less than you  
would like ........................................ 
 1 .............. 
 2 .............. 
 3 .............. 
 4 ............. 
5
c Did work or other activities  
less carefully than usual ................... 
 1 .............. 
 2 .............. 
 3 .............. 
 4 ............. 
5
Page 107 of 118


SF-36v2® Health Survey © 1992, 1996, 2000 Medical Outcomes Trust and QualityMetric Incorporated.  All rights reserved. 
SF-36® is a registered trademark of Medical Outcomes Trust. 
(SF-36v2® Health Survey Standard, United States (English)) 
6.
During the past 4 weeks, to what extent has your physical health or
emotional problems interfered with your normal social activities with
family, friends, neighbors, or groups?
Not at all 
Slightly 
Moderately 
Quite a bit 
Extremely 





1
2
3
4
5
7.
How much bodily pain have you had during the past 4 weeks?
None
Very mild 
Mild 
Moderate 
Severe
Very severe 






1
2
3
4
5
6
8.
During the past 4 weeks, how much did pain interfere with your normal
work (including both work outside the home and housework)?
Not at all 
A little bit 
Moderately 
Quite a bit 
Extremely 





1
2
3
4
5
Page 108 of 118


SF-36v2® Health Survey © 1992, 1996, 2000 Medical Outcomes Trust and QualityMetric Incorporated.  All rights reserved. 
SF-36® is a registered trademark of Medical Outcomes Trust. 
(SF-36v2® Health Survey Standard, United States (English)) 
9.
These questions are about how you feel and how things have been with you
during the past 4 weeks.  For each question, please give the one answer that
comes closest to the way you have been feeling.  How much of the time
during the past 4 weeks…
10.
During the past 4 weeks, how much of the time has your physical health or
emotional problems interfered with your social activities (like visiting with
friends, relatives, etc.)?
All of  
the time 
Most of  
the time 
Some of  
the time 
A little of  
the time 
None of  
the time 





1
2
3
4
5
All of  
the time 
Most of  
the time 
Some of 
the time 
A little of the 
time 
None of 
the time 





a Did you feel full of life? ..................
 1 ..............
 2 ..............
 3 ..............
 4 ..............
5
b Have you been very nervous? ..........
 1 .............. 
 2 ..............
 3 ..............
 4 ..............
5
c Have you felt so down in the  
dumps that nothing could  
cheer you up? ...................................
 1 ..............
 2 ..............
 3 ..............
 4 ..............
5
d Have you felt calm and   
peaceful? ..........................................
 1 .............. 
 2 ..............
 3 ..............
 4 ..............
5
e Did you have a lot of energy? ..........
 1 ..............
 2 ..............
 3 ..............
 4 ..............
5
f Have you felt downhearted  
and depressed? .................................
 1 .............. 
 2 ..............
 3 ..............
 4 ..............
5
g Did you feel worn out? ....................
 1 .............. 
 2 ..............
 3 ..............
 4 ..............
5
h Have you been happy? .....................
 1 .............. 
 2 ..............
 3 ..............
 4 ..............
5
i Did you feel tired? ...........................
 1 ..............
 2 ..............
 3 ..............
 4 ..............
5
Page 109 of 118


SF-36v2® Health Survey © 1992, 1996, 2000 Medical Outcomes Trust and QualityMetric Incorporated.  All rights reserved. 
SF-36® is a registered trademark of Medical Outcomes Trust. 
(SF-36v2® Health Survey Standard, United States (English)) 
11.
How TRUE or FALSE is each of the following statements for you?
Definitely 
true 
Mostly  
true 
Don’t  
know 
Mostly  
false 
Definitely 
false 

 


a I seem to get sick a little 
easier than other people .................. 
 1 .............. 
 2 ............. 
 3 .............. 
 4 .............. 
5
b
I am as healthy as  
anybody I know .............................. 
 1 .............. 
 2 ............. 
 3 .............. 
 4 .............. 
5
c
I expect my health to  
get worse ......................................... 
 1 .............. 
 2 ............. 
 3 .............. 
 4 .............. 
5
d
My health is excellent ..................... 
 1 .............. 
 2 ............. 
 3 .............. 
 4 .............. 
5
Thank you for completing these questions!
Page 110 of 118






                               EQ­5D­5L HEALTH QUESTIONNAIRE 

Under each heading, please check the ONE box that best describes your health TODAY.
MOBILITY 
I have no problems walking                     
I have slight problems walking                
I have moderate problems walking                                    
I have severe problems walking                                          
I am unable to walk                                                               
SELF­CARE 
I have no problems washing or dressing myself 
I have slight problems washing or dressing myself 
I have moderate problems washing or dressing myself 
I have severe problems washing or dressing myself 
I am unable to wash or dress myself 
USUAL ACTIVITIES (e.g. work, study, housework, family or leisure 
activities) 
I have no problems doing my usual activities 
I have slight problems doing my usual activities 
I have moderate problems doing my usual activities 
I have severe problems doing my usual activities 
I am unable to do my usual activities 
PAIN / DISCOMFORT 
I have no pain or discomfort 
I have slight pain or discomfort 
I have moderate pain or discomfort                      
I have severe pain or discomfort 
I have extreme pain or discomfort 
Page 113 of 118


                               EQ­5D­5L HEALTH QUESTIONNAIRE 

ANXIETY / DEPRESSION 
I am not anxious or depressed 
I am slightly anxious or depressed 
I am moderately anxious or depressed 
I am severely anxious or depressed 
I am extremely anxious or depressed 
Page 114 of 118


                               EQ­5D­5L HEALTH QUESTIONNAIRE 

8LI [SVWX LIE XL
]SY GER QEK RI
We would like to know how good or bad your health is TODAY. 
This scale is numbered from 0 to 100. 
100 means the best health you can imagine. 
0 means the worst health you can imagine. 
Mark an X on the scale to indicate how your health is TODAY. 
Now, please write the number you marked on the scale in the box below. 
=396 ,)%08, 83(%= !





















Page 115 of 118
 
 
 
 
 
 




JOINT REPLACEMENT QUESTIONNAIRE 
JOINT REPLACEMENT QUESTIONNAIRE , Version 2.0, 31-Aug-2017 
QUESTIONS TO BE ADMINISTERED AT ALL VISITS SUBSEQUENT TO BASELINE VISIT (TREATMENT VISIT 1/ DAY 1) 
Page 117 of 118
 
 
 
 
 
 
  
 
 
 
  
 
 
  
 
 
 
 
 
 
 
 
 
 
 
  


PATIENT GLOBAL IMPRESSION OF CHANGE IN KNEE PAIN 
Compared to before study treatment, the pain from my knee osteoarthritis is: 
(check only one response) 
very much improved
much improved
minimally improved
no change
minimally worse
much worse
very much worse
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