Randomized, Controlled, Single Blind, Prospective, Multicenter Study Evaluating Anatomic Versus Targeted Lead Placement for BurstDR Therapy During the Trial Evaluation Period. (DELIVERY)
Phase: NA
Conditions: Chronic, Intractable Pain of the Trunk and/or Lower Limbs
Sponsor: Abbott Medical Devices

 
Clinical Investigation Plan Cover Page 
 
 
 
This confidential document is the property of Abbott and shall not be reproduced, distributed, disclosed or used without the 
express written consent of Abbott. 
87173 CIP Posting Cover Page Ver B 
Template 
Page 1 of 39 
 
 
 
NCT Number: NCT03277378 
DELIVERY 
EValuating Anatomic vErsus TaRgeted Lead Placement for BurstDR TherapY During the Trial 
(DELIVERY) 
Study Document No: SJM-CIP-10116 
Version [C] 
Date: 4 October, 2019 
 
 
 
Sponsor  
 
 
Abbott 
        
 
 
 
The Corporate Village 
                                                    Da Vincilaan 11-boxF1 
      
  
 
 
1935 Zaventem, Belgium 
 
Abbott 
 
 
 
 
6901 Preston Road 
 
 
 
 
Plano, TX USA 75024 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
Study Document No: SJM-CIP-10116 Ver. [C] 
Study Name: DELIVERY 
 
Clinical Investigation Plan 
 
This confidential document is the property of Abbott and shall not be reproduced, distributed, disclosed or used without the 
express written consent of Abbott. 
86357_CIP Template_Rev_C 
Page 2 of 39 
                                             [REDACTED] 
 
 
 
 
DELIVERY 
Randomized, ControlleD, Single Blind, ProspEctive, MuLtIcenter Study EValuating Anatomic vErsus 
TaRgeted Lead Placement for BurstDR TherapY During the Trial Evaluation Period. 
CRD_767 
Study Document No: SJM-CIP-10116 
Version [C] 
Date: 21-JUN-2017 
Clinical Investigation Plan (CIP) 
 
 
Sponsor  
 
 
Abbott 
        
 
 
 
The Corporate Village 
                                                    Da Vincilaan 11-boxF1 
      
  
 
 
1935 Zaventem, Belgium 
                                                     
Abbott 
 
 
 
 
6901 Preston Road 
 
 
 
 
Plano, TX USA 75024 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
Study Document No: SJM-CIP-10116 Ver. [C] 
Study Name: DELIVERY 
 
Clinical Investigation Plan 
 
This confidential document is the property of Abbott and shall not be reproduced, distributed, disclosed or used without the 
express written consent of Abbott. 
86357_CIP Template_Rev_C 
Page 3 of 39 
                                             [REDACTED] 
 
 
 
PRINCIPAL INVESTIGATOR SIGNATURE PAGE 
 
 
 
 
I have read and agree to adhere to the clinical investigation plan and all regulatory requirements 
applicable in conducting this clinical investigation. 
 
 
Principal Investigator 
 
Printed name: 
Signature: 
Date: 
 
 
 
 


6WXG\'RFXPHQW1R6-0&,39HU>&@
6WXG\1DPH'(/,9(5<
&OLQLFDO,QYHVWLJDWLRQ 3ODQ

7KLVFRQILGHQWLDOGRFXPHQWLVWKHSURSHUW\RI$EERWWDQGVKDOOQRWEHUHSURGXFHGGLVWULEXWHGGLVFORVHGRUXVHGZLWKRXWWKH
H[SUHVVZULWWHQFRQVHQWRI$EERWW
B&,37HPSODWHB5HYB&
3DJHRI
>5('$&7('@


7DEOHRI&RQWHQWV

 
,QWURGXFWLRQ 
 
%DFNJURXQGDQG-XVWLILFDWLRQIRU&OLQLFDO,QYHVWLJDWLRQ 
 
'HYLFHV8QGHU,QYHVWLJDWLRQ 
 
,GHQWLILFDWLRQDQG'HVFULSWLRQRIWKH'HYLFHVXQGHULQYHVWLJDWLRQ 
 
,GHQWLILFDWLRQ 
 
'HYLFH'HVFULSWLRQDQG,QWHQGHG3XUSRVH 
 
'HYLFH+DQGOLQJDQG6WRUDJH 
 
'HYLFHV$FFRXQWDELOLW\ 
 
&OLQLFDO,QYHVWLJDWLRQ'HVLJQ 
 
&OLQLFDO,QYHVWLJDWLRQ'HVLJQ 
 
2EMHFWLYHV 
 
3ULPDU\2EMHFWLYH 
 
6HFRQGDU\2EMHFWLYH 
 
(QGSRLQWV 
 
3ULPDU\(QGSRLQW 
 
6HFRQGDU\(QGSRLQW 
 
'HVFULSWLYH(QGSRLQWV 
 
6WXG\3RSXODWLRQ 
 
,QFOXVLRQ&ULWHULD 
 
([FOXVLRQ&ULWHULD 
 
3URFHGXUHV 
 
,QIRUPHG&RQVHQW3URFHVV 
 
6FUHHQLQJ 
 
3RLQWRI(QUROOPHQW 
 
6FKHGXOHG3URFHGXUHV 
 
(QUROOPHQW%DVHOLQH9LVLW 
 
5DQGRPL]DWLRQDQG%OLQGLQJ 
 
7ULDO6\VWHP,PSODQW,QLWLDO7ULDO(YDOXDWLRQ3HULRG6WDUW 
 
(QGRI,QLWLDO7ULDO(YDOXDWLRQ9LVLW 
 
(QGRI([WHQGHG7ULDO(YDOXDWLRQ3HULRGLIDSSOLFDEOH 
 
8QVFKHGXOHG9LVLWV 
 
3DWLHQW5HSRUWHG2XWFRPH352PHDVXUHV 
 
1XPHULFDO5DWLQJ6FDOH156 
 
3DWLHQW5HSRUWHG3DLQUHOLHI353 
 
,WHP$GXOW6FDOHRIWKH3DWLHQW5HSRUWHG2XWFRPHV0HDVXUHPHQW,QIRUPDWLRQ6\VWHP
3520,6'H\R5DPVD\%XFNOH\HWDO 


6WXG\'RFXPHQW1R6-0&,39HU>&@
6WXG\1DPH'(/,9(5<
&OLQLFDO,QYHVWLJDWLRQ 3ODQ

7KLVFRQILGHQWLDOGRFXPHQWLVWKHSURSHUW\RI$EERWWDQGVKDOOQRWEHUHSURGXFHGGLVWULEXWHGGLVFORVHGRUXVHGZLWKRXWWKH
H[SUHVVZULWWHQFRQVHQWRI$EERWW
B&,37HPSODWHB5HYB&
3DJHRI
>5('$&7('@


 
3DLQ&DWDVWURSKL]LQJ6FDOH3&66XOOLYDQ%LVKRS	3LYLN 
 
6WLPXODWLRQ$VVHVVPHQW 
 
&OLQLFLDQ$VVHVVPHQWV 
 
'HVFULSWLRQRI$FWLYLWLHV3HUIRUPHGE\6SRQVRU5HSUHVHQWDWLYHV 
 
6XEMHFW6WXG\&RPSOHWLRQ 
 
6XEMHFW:LWKGUDZDO 
 
6WXG\&RPPLWWHHV 
 
6WHHULQJ&RPPLWWHH6& 
 
6WDWLVWLFDO&RQVLGHUDWLRQV 
 
+\SRWKHVHV 
 
3ULPDU\(QGSRLQW+\SRWKHVLV 
 
6HFRQGDU\(QGSRLQW+\SRWKHVLV 
 
-XVWLILFDWLRQRI&OLQLFDO,QYHVWLJDWLRQ'HVLJQ 
 
0XOWLSOLFLW\ 
 
2YHUDOO6DPSOH6L]H 
 
'HVFULSWLYH(QGSRLQWV 
 
7LPLQJRI$QDO\VLV 
 
6XFFHVV&ULWHULD 
 
,QWHULP$QDO\VLV 
 
6WDWLVWLFDO&ULWHULDIRU7HUPLQDWLRQ 
 
'HYLDWLRQVIURP6WDWLVWLFDO3ODQ 
 
5LVNVDQG%HQHILWV 
 
5LVNV$VVRFLDWHGZLWKWKH'HYLFH8QGHU,QYHVWLJDWLRQ 
 
$QWLFLSDWHG$GYHUVH'HYLFH(IIHFWV 
 
5LVNV$VVRFLDWHGZLWK&OLQLFDO,QYHVWLJDWLRQ$VVHVVPHQWV 
 
5LVN&RQWURO0HDVXUHV 
 
3RVVLEOHLQWHUDFWLRQVZLWKFRQFRPLWDQWWUHDWPHQWV 
 
5LVNWR%HQHILW5DWLRQDOH 
 
5HTXLUHPHQWVIRU,QYHVWLJDWRU5HFRUGVDQG5HSRUWV 
 
'HYLDWLRQVIURP&,3 
 
6DIHW\5HSRUWLQJ 
 
&RPSODLQWV'HYLFH'HILFLHQFLHV 
 
6RXUFHUHFRUGV 
 
5HFRUGV5HWHQWLRQ 
 
&OLQLFDO'DWD+DQGOLQJ 
 
3URWHFWLRQRI3HUVRQDOO\,GHQWLILDEOH,QIRUPDWLRQ 
 
'DWD0DQDJHPHQW3ODQ 


6WXG\'RFXPHQW1R6-0&,39HU>&@
6WXG\1DPH'(/,9(5<
&OLQLFDO,QYHVWLJDWLRQ 3ODQ

7KLVFRQILGHQWLDOGRFXPHQWLVWKHSURSHUW\RI$EERWWDQGVKDOOQRWEHUHSURGXFHGGLVWULEXWHGGLVFORVHGRUXVHGZLWKRXWWKH
H[SUHVVZULWWHQFRQVHQWRI$EERWW
B&,37HPSODWHB5HYB&
3DJHRI
>5('$&7('@


 
'RFXPHQWDQG'DWD&RQWURO 
 
7UDFHDELOLW\RI'RFXPHQWVDQG'DWD 
 
5HFRUGLQJ'DWD 
 
0RQLWRULQJ 
 
&RPSOLDQFH6WDWHPHQW 
 
6WDWHPHQWRI&RPSOLDQFH 
 
4XDOLW\$VVXUDQFH$XGLWVDQG5HJXODWRU\,QVSHFWLRQV 
 
5HSHDWHGDQG6HULRXV1RQ&RPSOLDQFH 
 
6XVSHQVLRQRU3UHPDWXUH7HUPLQDWLRQRIWKH&OLQLFDO,QYHVWLJDWLRQ 
 
&OLQLFDO,QYHVWLJDWLRQ&RQFOXVLRQ 
 
3XEOLFDWLRQ3ROLF\ 
 
5HSRUWLQJ5HVXOWVRQ&OLQFDO7ULDOVJRY:HEVLWH 
 
$SSHQGL[$&,35HYLVLRQV 
 
$SSHQGL[%'HILQLWLRQV 
 
$SSHQGL[&%XUVW'53URJUDPPLQJ*XLGHOLQHV 
 
$SSHQGL[',PDJLQJ*XLGHOLQHV 
 
$SSHQGL[(%LEOLRJUDSK\ 
 
$SSHQGL[)&DVH5HSRUW)RUP 
 
$SSHQGL[*,QIRUPHG&RQVHQW)RUP 




 
Study Document No: SJM-CIP-10116 Ver. [C] 
Study Name: DELIVERY 
 
Clinical Investigation Plan 
 
This confidential document is the property of Abbott and shall not be reproduced, distributed, disclosed or used without the 
express written consent of Abbott. 
86357_CIP Template_Rev_C 
Page 7 of 39 
                                             [REDACTED] 
 
 
1 
Introduction 
This document is a clinical investigation plan (CIP) for the clinical investigation of the SJM™ Invisible Trial 
System with market-approved lead(s). This clinical investigation is intended to evaluate anatomic versus 
targeted lead placement for BurstDR™ therapy during the trial evaluation period. 
 
This clinical investigation is sponsored by Abbott (ABT). 
 
This clinical investigation will be conducted in accordance with this CIP. All parties involved in the conduct 
of the clinical investigation will be qualified by education, training, or experience to perform their tasks and 
this training will be documented appropriately. 
2 
Background and Justification for Clinical Investigation 
Spinal cord stimulation (SCS) reduces pain and improves function and quality of life for patients with 
chronic, intractable pain1. Typically, patients, who are candidates for SCS have failed other treatment 
options, are recommended by their physician to participate in a SCS trial evaluation period with 
percutaneously implanted leads powered by an external generator. The trial evaluation period can span 
from 3 to 30 days (or more) depending on the patient needs, physician’s discretion, and regional 
reimbursement requirements. Successful trial evaluation of the SCS device is contingent upon adequate 
pain relief and/or functional improvements as assessed by the patient and the physician. Standard of care 
for “successful” trial evaluations is driven by reimbursement in most countries, which typically includes, but 
may not be limited to, patient assessment of 50% pain relief and willingness to proceed to a permanent 
implantable pulse generator (IPG).  
 
Until recently, SCS trials and permanent systems delivered tonic stimulation (See Figure 1), which delivers 
a stream of pulses at consistent amplitude, pulse width and frequency. Tonic stimulation produces 
paresthesia, a tingling sensation, in the areas of stimulation coverage. Outcomes during the trial evaluation 
are thought to predict long-term success with therapy, though evidence in the literature is sparse due to 
poor reporting of trial experiences. Rates of successful trial evaluations leading to permanent implant vary 
in the literature (41% to 71% or more).2,3 
 
Recently, BurstDR™ stimulation mode was approved in Europe and the US for use in permanently 
implanted systems (CE mark: March 2014 and PMA: October 2016). BurstDR™ programmable parameters 
include (A) the burst train, (B) the time of onset of the burst train to the time of onset of the next burst train 
(burst rate), and (C) the rate of pulses within each train (intra-burst rate) (See Figure 2). While BurstDR™ 
features a group of pulses that are repeated in an on/off pattern, it is unlike cycle mode because it mimics 
the natural signaling of burst neurons utilizing closely spaced stimuli. The amplitudes used for BurstDR™ 
stimulation are reported to be significantly lower than those traditionally used for tonic stimulation which 
results in pain suppression that is generally sensation free (e.g., does not produce paresthesia). 
 
The St. Jude Medical™ Invisible Trial System, capable of delivering both tonic and BurstDR™ stimulation, 
was approved (CE mark: June 2015 and PMA: July 2015). The Invisible Trial System consists of an External 
Pulse Generator (EPG) and a Patient Controller. The EPG is smaller than other systems on the market and 
is designed to be bandaged to the patient’s back, which eliminates access to connector wires to reduce 
dislodgement and lead migrations. Furthermore, the EPG is controlled wirelessly via Bluetooth™ low 
energy technology with the Patient Controller.  
 
Lead placement for BurstDR™ has proceeded to use temporary tonic stimulation such that the sensory 
qualities of tonic programming (paresthesias) can be used to elicit feedback from patients and ensure the 
leads are properly placed and programmed. Because BurstDR™ results in sensation-free therapy for most 
patients, it has been proposed that anatomic placement of the leads could result in effective therapy while 


6WXG\'RFXPHQW1R6-0&,39HU>&@
6WXG\1DPH'(/,9(5<
&OLQLFDO,QYHVWLJDWLRQ 3ODQ

7KLVFRQILGHQWLDOGRFXPHQWLVWKHSURSHUW\RI$EERWWDQGVKDOOQRWEHUHSURGXFHGGLVWULEXWHGGLVFORVHGRUXVHGZLWKRXWWKH
H[SUHVVZULWWHQFRQVHQWRI$EERWW
B&,37HPSODWHB5HYB&
3DJHRI
>5('$&7('@


UHGXFLQJSURFHGXUHWLPHVGXULQJERWKWKHWULDOHYDOXDWLRQDQGSHUPDQHQWV\VWHPLPSODQWV1RVWXGLHVKDYH
LQYHVWLJDWHGWKLVSURFHGXUDOYDULDWLRQWRGDWH

$GGLWLRQDOO\WKHUHLVQRSXEOLVKHGOLWHUDWXUHIRUWKHXVHRI%XUVW'5RUWKH,QYLVLEOH7ULDO6\VWHPGXULQJ
WKHWULDOHYDOXDWLRQSHULRGDQGWKXVQRTXDQWLWDWLYHH[DPLQDWLRQRIWKHUDWHRIVXFFHVVIXOTXDOLILFDWLRQIRU
SHUPDQHQWLPSODQWZKHQWKLVWKHUDS\PRGHDQGGHYLFHLVXVHGGXULQJWKHWULDOHYDOXDWLRQSHULRG

7KHUHIRUHWKHDLPVRIWKHSURSRVHGFOLQLFDOLQYHVWLJDWLRQDUHWRHYDOXDWHWKHTXDOLILFDWLRQUDWHRI%XUVW'5
LQFRQMXQFWLRQZLWKWKH,QYLVLEOH7ULDO6\VWHPGXULQJWKHWULDOHYDOXDWLRQSHULRGIRU%XUVW'5WKHUDS\YLD
DQDWRPLFYHUVXVWDUJHWHGOHDGSODFHPHQW

)LJXUHWRQLFSDWWHUQ




)LJXUH%XUVW'5SDWWHUQ



'HYLFHV8QGHU,QYHVWLJDWLRQ

,GHQWLILFDWLRQDQG'HVFULSWLRQRIWKH'HYLFHVXQGHULQYHVWLJDWLRQ

,GHQWLILFDWLRQ

,QWKLVFOLQLFDOLQYHVWLJDWLRQWKH6-0,QYLVLEOH7ULDO6\VWHPLVEHLQJXVHGDQGFRQVLVWVRIDQ([WHUQDO
3XOVH*HQHUDWRU(3*D&OLQLFLDQ3URJUDPPHUDQGD3DWLHQW&RQWUROOHU7KHFRPSRQHQWVFRPPXQLFDWH
ZLWKHDFKRWKHUYLDZLUHOHVV%OXHWRRWKFRPPXQLFDWLRQ







6WXG\'RFXPHQW1R6-0&,39HU>&@
6WXG\1DPH'(/,9(5<
&OLQLFDO,QYHVWLJDWLRQ 3ODQ

7KLVFRQILGHQWLDOGRFXPHQWLVWKHSURSHUW\RI$EERWWDQGVKDOOQRWEHUHSURGXFHGGLVWULEXWHGGLVFORVHGRUXVHGZLWKRXWWKH
H[SUHVVZULWWHQFRQVHQWRI$EERWW
B&,37HPSODWHB5HYB&
3DJHRI
>5('$&7('@


7DEOH,GHQWLILFDWLRQRI'HYLFHVXQGHU,QYHVWLJDWLRQ

'HYLFHQDPH
0RGHO7\SH
0DQXIDFWXUHU
5HJLRQ&RXQWU\
,QYHVWLJDWLRQDORU
0DUNHW5HOHDVHG
6-070,QYLVLEOH7ULDO
6\VWHP

6-0
(0($$1=&$86
0DUNHW5HOHDVHG
&OLQLFLDQ
3URJUDPPHU
L3DG0LQL


6-0
(0($$1=&$86
0DUNHW5HOHDVHG
3DWLHQW&RQWUROOHU
L3RG7RXFK


6-0
(0($$1=&$86
0DUNHW5HOHDVHG


'HYLFH'HVFULSWLRQDQG,QWHQGHG3XUSRVH
7KH6-0,QYLVLEOH7ULDO6\VWHPLVLQGLFDWHGIRUXVHLQVXEMHFWVDVDQDLGLQWKHPDQDJHPHQWRIFKURQLF
LQWUDFWDEOHSDLQRIWKHWUXQNDQGRUOLPEVDQGLVXVHGGXULQJWKHWULDOV\VWHPHYDOXDWLRQSHULRG,WFRQVLVWV
RIDQ([WHUQDO3XOVH*HQHUDWRU(3*D&OLQLFLDQ3URJUDPPHUDQGD3DWLHQW&RQWUROOHU7KHFRPSRQHQWV
FRPPXQLFDWHZLWKHDFKRWKHUYLDZLUHOHVV%OXHWRRWK/RZ(QHUJ\%/(FRPPXQLFDWLRQ

'HYLFH+DQGOLQJDQG6WRUDJH
7KHGHYLFHVXVHGGXULQJWKLVFOLQLFDOLQYHVWLJDWLRQDUHFRPPHUFLDOO\DYDLODEOHDQGZLOOEHKDQGOHGDQG
VWRUHGDFFRUGLQJWRWKHDSSOLFDEOHSURGXFWPDQXDOVDQGVWDQGDUGVLWHSUDFWLFHV

'HYLFHV$FFRXQWDELOLW\
7KHGHYLFHVXVHGGXULQJWKLVFOLQLFDOLQYHVWLJDWLRQDUHFRPPHUFLDOO\DYDLODEOHDQGGHYLFHDFFRXQWDELOLW\LV
QRWUHTXLUHG

&OLQLFDO,QYHVWLJDWLRQ'HVLJQ

&OLQLFDO,QYHVWLJDWLRQ'HVLJQ
7KLVLVDUDQGRPL]HGFRQWUROOHGVLQJOHEOLQGPXOWLFHQWHUFOLQLFDOLQYHVWLJDWLRQFRPSDULQJVXFFHVVUDWHV
IRU DQDWRPLFDOO\ SODFHG OHDGV WR FRQYHQWLRQDO WDUJHWHG OHDG SODFHPHQW IRU %XUVW'5 GXULQJ WKH WULDO
HYDOXDWLRQSHULRGZLWKWKH6-0,QYLVLEOH7ULDO6\VWHP6XEMHFWVZLOOEHEOLQGHGWRWUHDWPHQWJURXSDQG
UDQGRPL]HGLQDUDWLRDVIROORZV

x
*URXS$%DQDWRPLFOHDGSODFHPHQWIROORZHGE\%XUVW'5VWLPXODWLRQGXULQJDQLQLWLDOWULDO
HYDOXDWLRQSHULRG
x
*URXS7%WDUJHWHGOHDGSODFHPHQWIROORZHGE\%XUVW'5VWLPXODWLRQGXULQJDQLQLWLDOWULDO
HYDOXDWLRQSHULRG

,I WKH VXEMHFW TXDOLILHV IRU SHUPDQHQW V\VWHP LPSODQW DV GHILQHG LQ VHFWLRQ  DIWHU WKH LQLWLDO WULDO
HYDOXDWLRQ SHULRG WKH VXEMHFW ZLOO H[LW WKH FOLQLFDO LQYHVWLJDWLRQ DQG FRQWLQXH WKHLU WUHDWPHQW SHU WKH
SK\VLFLDQ¶V VWDQGDUG RI FDUH 6XEMHFWV ZKR GR QRW TXDOLI\ IRU SHUPDQHQW V\VWHP LPSODQW DV GHILQHG LQ
VHFWLRQDIWHUWKHLQLWLDOWULDOHYDOXDWLRQSHULRGPD\SDUWLFLSDWHLQDQH[WHQGHGWULDOHYDOXDWLRQSHULRG
SHUSK\VLFLDQGLVFUHWLRQGXULQJZKLFKWKH\ZLOOEHSURJUDPPHGZLWKWRQLFVWLPXODWLRQ6XEMHFWVFRQWLQXLQJ
WRDQH[WHQGHGWULDOHYDOXDWLRQSHULRGZLOOEHIROORZHGWKURXJKWKHFRPSOHWLRQRIWKHH[WHQGHGWULDOSHULRG
$WWKHHQGRIWKHH[WHQGHGWULDOHYDOXDWLRQSHULRGVXEMHFWVZLOOH[LWWKHFOLQLFDOLQYHVWLJDWLRQ


 
Study Document No: SJM-CIP-10116 Ver. [C] 
Study Name: DELIVERY 
 
Clinical Investigation Plan 
 
This confidential document is the property of Abbott and shall not be reproduced, distributed, disclosed or used without the 
express written consent of Abbott. 
86357_CIP Template_Rev_C 
Page 10 of 39 
                                             [REDACTED] 
 
 
End of Extended Trial 
Period
Extended Trial Period
End of Initial Trial Period
Qualify for Permanent 
Implant?
Initial Trial Period
Randomization (1:1)
Enrollment/
Baseline
Anatomical Lead 
Placement (AB)
BurstDRTM for 3-
5 Days
Yes
Exit Study
No
Tonic 
Stimulation for 
additional min .3 
days (optional)
Exit Study
Targeted Lead 
Placement (TB)
BurstDRTM for 3-
5 Days
Yes
Exit Study
No
Tonic 
Stimulation for 
additional min. 3 
days (optional)
Exit Study
The randomization diagram (Figure 3) and the study flow chart (Figure 4) are shown below.  
 
Figure 3: Randomization Diagram 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Figure 4: Study Flow Chart 
 
Initial Trial 
Evaluation 
(all subjects) 
RANDOMIZATION 
Group 1 
(AB) 
BurstDR™ 
stimulation 
Anatomic 
Lead 
Group 2 
(tB) 
BurstDR™ 
stimulation 
Targeted 
Lead 
Extended Trial 
Evaluation  
(if applicable) 
Tonic stimulation 
Tonic stimulation 


6WXG\'RFXPHQW1R6-0&,39HU>&@
6WXG\1DPH'(/,9(5<
&OLQLFDO,QYHVWLJDWLRQ 3ODQ

7KLVFRQILGHQWLDOGRFXPHQWLVWKHSURSHUW\RI$EERWWDQGVKDOOQRWEHUHSURGXFHGGLVWULEXWHGGLVFORVHGRUXVHGZLWKRXWWKH
H[SUHVVZULWWHQFRQVHQWRI$EERWW
B&,37HPSODWHB5HYB&
3DJHRI
>5('$&7('@


$SSUR[LPDWHO\VXEMHFWVZLOOEHHQUROOHGDWXSWRVLWHVLQWKH(0($$1=&$DQG86UHJLRQV
6XEMHFWVSDUWLFLSDWLQJLQWKLVFOLQLFDOLQYHVWLJDWLRQZLOOEHIROORZHGIRUWKHGXUDWLRQRIWKHLUWULDOHYDOXDWLRQ
SHULRGRQO\(QUROOPHQWLQWKLVFOLQLFDOLQYHVWLJDWLRQLVDQWLFLSDWHGWRODVWDSSUR[LPDWHO\PRQWKV7KHWRWDO
GXUDWLRQRIWKHFOLQLFDOLQYHVWLJDWLRQLVH[SHFWHGWREHDSSUR[LPDWHO\PRQWKV

2EMHFWLYHV

3ULPDU\2EMHFWLYH
7KHSULPDU\REMHFWLYHLQWKLVFOLQLFDOLQYHVWLJDWLRQLVWRGHPRQVWUDWHWKDWWKHTXDOLILFDWLRQUDWHZLWKDQDWRPLF
OHDG SODFHPHQW LV QRQLQIHULRU WR WKH TXDOLILFDWLRQ UDWH ZLWK WDUJHWHG OHDG SODFHPHQW WRQLF SDUHVWKHVLD
JXLGHGIRUWKH%XUVW'570VWLPXODWLRQWULDOHYDOXDWLRQSHULRG

6HFRQGDU\2EMHFWLYH
7KHVHFRQGDU\REMHFWLYHRIWKLVFOLQLFDOLQYHVWLJDWLRQLVWRHVWDEOLVKDKLJKHUUDWHRISK\VLFLDQSUHIHUHQFH
IRUDQDWRPLFOHDGSODFHPHQWSURFHGXUH

(QGSRLQWV
7KHUHLVRQHSULPDU\HQGSRLQWDQGRQHVHFRQGDU\HQGSRLQWLQWKLVFOLQLFDOLQYHVWLJDWLRQ

3ULPDU\(QGSRLQW
7KHSULPDU\HQGSRLQWLVWKHTXDOLILFDWLRQUDWHIRUSHUPDQHQWV\VWHPLPSODQWDWWKHHQGRIWKHLQLWLDOWULDO
HYDOXDWLRQSHULRG

4XDOLILFDWLRQIRUSHUPDQHQWV\VWHPLPSODQWLVGHILQHGE\DFRPSRVLWHLQZKLFKDVXEMHFWPHHWVDOORIWKH
IROORZLQJFRQGLWLRQV

!SDWLHQWUHSRUWHGSDLQUHOLHI353DWWKHHQGRIWKHWULDOHYDOXDWLRQ

7ULDOHYDOXDWLRQSHULRGODVWHGIRUDPLQLPXPRIGD\V

3K\VLFLDQUHFRPPHQGVVXEMHFWIRUSHUPDQHQWV\VWHPLPSODQW

6XEMHFWUHSRUWVDZLOOLQJQHVVWRSXUVXHDSHUPDQHQWV\VWHPLPSODQW

6XEMHFWVDUHQRWTXDOLILHGIRUSHUPDQHQWV\VWHPLPSODQWLIWKH\PHHWERWKRIWKHIROORZLQJ

353SDWLHQWUHSRUWHGSDLQUHOLHIDWWKHHQGRIWKHWULDOHYDOXDWLRQ

7ULDOHYDOXDWLRQSHULRGODVWHGIRUDPLQLPXPRIGD\V

6HFRQGDU\(QGSRLQW
7KHVHFRQGDU\HQGSRLQWLVWKHUDWHRISK\VLFLDQSUHIHUHQFHIRUDQDWRPLFSODFHPHQWYHUVXVWDUJHWHG
SODFHPHQWDWWKHHQGRIWKHVWXG\

'HVFULSWLYH(QGSRLQWV
'HVFULSWLYHHQGSRLQWVDUHUHSRUWHGXVLQJRQO\VXPPDU\VWDWLVWLFVDQGQRK\SRWKHVLVWHVWVZLOOEHSHUIRUPHG

 2YHUDOOSURFHGXUHWLPHLQURRPWRRXWURRPLPSODQWSURFHGXUHWLPHQHHGOHLQWRQHHGOHRXW
DQGWRWDOWLPHRILQWUDRSHUDWLYHIOXRURVFRS\H[SRVXUHIRUHDFKUDQGRPL]HGJURXSDQGVWUDWLILHGE\
QXPEHURIOHDGVDQGOHDGW\SHSHUPDQHQWOHDGRUWHPSRUDU\OHDG
 3URJUDPPLQJWLPHUHTXLUHGIRUHDFKUDQGRPL]HGJURXS
 &KDQJHIURPSUHLPSODQW1XPHULFDO5DWLQJ6FDOH156LQHDFKUDQGRPL]HGJURXSWRHQGRILQLWLDO
WULDOHYDOXDWLRQSHULRGDQGWRWKHHQGRIWKHH[WHQGHGWULDOHYDOXDWLRQSHULRGDVDSSOLFDEOH
 1XPEHURIVXEMHFWVLQHDFKUDQGRPL]HGJURXSZKRKDYHDIILUPDWLYHDVVHVVPHQWIRUHDFKRIWKH
LQGHSHQGHQWFULWHULDUHTXLUHGIRUTXDOLILFDWLRQIRUSHUPDQHQWLPSODQW


6WXG\'RFXPHQW1R6-0&,39HU>&@
6WXG\1DPH'(/,9(5<
&OLQLFDO,QYHVWLJDWLRQ 3ODQ

7KLVFRQILGHQWLDOGRFXPHQWLVWKHSURSHUW\RI$EERWWDQGVKDOOQRWEHUHSURGXFHGGLVWULEXWHGGLVFORVHGRUXVHGZLWKRXWWKH
H[SUHVVZULWWHQFRQVHQWRI$EERWW
B&,37HPSODWHB5HYB&
3DJHRI
>5('$&7('@


 3URSRUWLRQ RI VXEMHFWV LQ HDFK UDQGRPL]HG JURXS ZKR GR QRW TXDOLI\ IRU SHUPDQHQW LPSODQW
KRZHYHUGRSURFHHGZLWKSHUPDQHQWLPSODQWSHUSK\VLFLDQGLVFUHWLRQ
 7LPHIURPWULDOV\VWHPLPSODQWWR!353PHDVXUHGE\WKHQXPEHURIGD\VDOVRNQRZQDV
³ZDVKLQSHULRG´
 5DWHRIVHULRXVDGYHUVHGHYLFHHIIHFWV6$'(LQHDFKJURXS
 1XPEHUDQGSURSRUWLRQRIPHDQLQJIXOOHDGPLJUDWLRQVGXULQJWKHLQLWLDOWULDOHYDOXDWLRQSHULRGVE\
WUHDWPHQWJURXS
 1XPEHUDQGSURSRUWLRQRIPHDQLQJIXOOHDGPLJUDWLRQVGXULQJWKHLQLWLDOWULDOHYDOXDWLRQSHULRGLQ
VXEMHFWVZKRKDYHDWHPSRUDU\WULDOOHDGLPSODQWFRPSDUHGWRVXEMHFWVZKRKDYHDSHUPDQHQWWULDO
OHDGLPSODQW
&OLQLFLDQDVVHVVPHQWRIDQHVWKHVLDUHODWHGGLIILFXOW\DVVHVVHGSULPDULO\LQWKHSURFHGXUHURRPIRU
WKHWULDORQDSRLQWOLNHUWVFDOHIRUHDFKUDQGRPL]HGJURXS
&OLQLFLDQDVVHVVPHQWRIOHDGSODFHPHQWGLIILFXOW\RQDSRLQWOLNHUWVFDOHIRUHDFK UDQGRPL]HG
JURXS
&OLQLFLDQDIILQLW\OLNLQJIRUOHDGSODFHPHQWWHFKQLTXHDWWKHHQGRIWKHWULDOLPSODQWSURFHGXUH
3HUPDQHQWV\VWHPTXDOLILFDWLRQUDWHDWWKHHQGRIH[WHQGHGWULDOSHULRG

$PHDQLQJIXOOHDGPLJUDWLRQLVGHILQHGDVDOHDGPLJUDWLRQUHVXOWLQJLQWKHLQDELOLW\WRSURJUDPIRUWKHUDSHXWLF
UHVSRQVH

6WXG\3RSXODWLRQ
7KHLQWHQGHGSRSXODWLRQIRUWKLVFOLQLFDOLQYHVWLJDWLRQLVSDWLHQWVRYHUWKHDJHRI\HDUVWKDWKDYHFKURQLF
LQWUDFWDEOHSDLQRIWKHWUXQNDQGRUORZHUOLPEVDQGKDYHEHHQUHFRPPHQGHGE\DSK\VLFLDQIRUVSLQDOFRUG
VWLPXODWLRQWKHUDS\

,QFOXVLRQ&ULWHULD
7RSDUWLFLSDWHLQWKLVFOLQLFDOLQYHVWLJDWLRQWKHSDWLHQWPXVWPHHWDOORIWKHIROORZLQJLQFOXVLRQFULWHULD

 3DWLHQWLQGLFDWHGIRU6&6WKHUDS\LQDFFRUGDQFHZLWKWKHDSSURYHGODEHOLQJ
 3DWLHQW¶VSDLQSURILOHLQGLFDWHVDSSURSULDWHOHDGSODFHPHQWZRXOGEHDWRQHRUPRUHOHYHOVIURP
7WR7WRDFKLHYHSDLQFRYHUDJH
 3DWLHQWKDVDEDVHOLQHVFRUHRQWKH156RYHUWKHSDVWKRXUVIRUµDYHUDJHRYHUDOOSDLQ¶
VSHFLILFWRWKHDUHDVRIFKURQLFSDLQWKDWZLOOEHWUHDWHGZLWKVSLQDOFRUGVWLPXODWLRQ
 3DWLHQWLVFRQVLGHUHGE\WKH6WXG\,QYHVWLJDWRUDVDFDQGLGDWHIRULPSODQWDWLRQRIDVSLQDOFRUG
VWLPXODWRUV\VWHPDFFRUGLQJWRWKHV\VWHP,QVWUXFWLRQVIRU8VH
 3DWLHQWLV!\HDUVRIDJHDWWKHWLPHRIHQUROOPHQW
 3DWLHQWLVZLOOLQJWRDGKHUHWRWKHVWXG\UHTXLUHPHQWVLQFOXGLQJFRPSOLDQFHZLWKDQGFRPSOHWLRQ
RIDOOVWXG\YLVLWV
 3DWLHQWKDVVLJQHGDQGUHFHLYHGDFRS\RIWKH(&,5%DSSURYHGLQIRUPHGFRQVHQW

([FOXVLRQ&ULWHULD
3DWLHQWVDUHQRWHOLJLEOHIRUFOLQLFDOLQYHVWLJDWLRQSDUWLFLSDWLRQLIWKH\PHHWDQ\RIWKHIROORZLQJH[FOXVLRQ
FULWHULD

 3DWLHQWFXUUHQWO\KDVDVSLQDOFRUGVWLPXODWLRQV\VWHPLPSODQWHG
 3DWLHQWKDVSUHYLRXVO\IDLOHGDVSLQDOFRUGVWLPXODWLRQWKHUDS\HLWKHUWULDOV\VWHPHYDOXDWLRQRU
SHUPDQHQWV\VWHPLPSODQW
 3DWLHQW KDV D SULPDU\ GLDJQRVLV RI 3HULSKHUDO 9DVFXODU 'LVHDVH 39' $QJLQD 3HFWRULV RU
&KURQLF0LJUDLQH
 3DWLHQWLVVFKHGXOHGWRXQGHUJRDQRQWKHWDEOHWULDOHYDOXDWLRQDNDDOOLQRQHSURFHGXUH
 3DWLHQWLVVFKHGXOHGWREHLPSODQWHGZLWKDVXUJLFDOSDGGOHWULDOOHDGV


6WXG\'RFXPHQW1R6-0&,39HU>&@
6WXG\1DPH'(/,9(5<
&OLQLFDO,QYHVWLJDWLRQ 3ODQ

7KLVFRQILGHQWLDOGRFXPHQWLVWKHSURSHUW\RI$EERWWDQGVKDOOQRWEHUHSURGXFHGGLVWULEXWHGGLVFORVHGRUXVHGZLWKRXWWKH
H[SUHVVZULWWHQFRQVHQWRI$EERWW
B&,37HPSODWHB5HYB&
3DJHRI
>5('$&7('@


 3DWLHQWLVFXUUHQWO\SDUWLFLSDWLQJLQDQRWKHUFOLQLFDOLQYHVWLJDWLRQZLWKDQDFWLYHWUHDWPHQWDUP
 3DWLHQWLVXQDEOHWRUHDGDQGRUZULWH

3URFHGXUHV
$SSURYDOIURPWKH6SRQVRUPXVWEHUHFHLYHGSULRUWRLQLWLDWLQJVWXG\SURFHGXUHV

3DWLHQWVDUHFRQVLGHUHGHQUROOHGLQWKHVWXG\DQGEHFRPHVXEMHFWVIURPWKHPRPHQWWKHSDWLHQWVKDYH
SURYLGHGZULWWHQ3DWLHQW,QIRUPHG&RQVHQW

(QUROOHGVXEMHFWVZLOOEHUDQGRPL]HGEHIRUHDQ\VWXG\SURFHGXUHLVSHUIRUPHG6XEMHFWVZLOOXQGHUJRDWULDO
V\VWHP LPSODQW SURFHGXUH ZLWK OHDG SODFHPHQW DFFRUGLQJ WR WKHLU UDQGRPL]DWLRQ JURXS )ROORZXS RI
VXEMHFWVZLOOEHDFFRUGLQJWRWKHVLWH¶VSUDFWLFH8SRQFRPSOHWLRQRIWKHLQLWLDOWULDOHYDOXDWLRQSHULRGWKH
VXEMHFWZLOOEHFRQVLGHUHGWRKDYHFRPSOHWHGWKHVWXG\LIKHVKHTXDOLILHVIRUSHUPDQHQWLPSODQW,QFDVH
WKH VXEMHFW GRHV QRW TXDOLI\ IRU SHUPDQHQW LPSODQW WKH WULDO HYDOXDWLRQ SHULRG PD\ EH H[WHQGHG SHU
SK\VLFLDQGLVFUHWLRQ7KHH[WHQGHGWULDOHYDOXDWLRQSHULRGZLOOFRQWLQXHIRUDQDGGLWLRQDOPLQLPXPRIGD\V
DQGZLOOHQGSHUVWDQGDUGRIFDUH6XEMHFWVZKRGRQRWFKRRVHWRHQWHUWKHH[WHQGHGWULDOHYDOXDWLRQSHULRG
ZLOOH[LWWKHVWXG\

7KH3ULQFLSDO,QYHVWLJDWRUVKRXOGDUUDQJHIRUDSSURSULDWHFDUHRIVXEMHFWVIROORZLQJVWXG\FRPSOHWLRQ
7KH3ULQFLSDO,QYHVWLJDWRULVUHVSRQVLEOHIRUHQVXULQJDOOFOLQLFDOLQYHVWLJDWLRQGDWDDUHFROOHFWHGDVUHTXLUHG
SHU&,3VFKHGXOHGSURFHGXUHV

7KHIROORZLQJVHFWLRQVSURYLGHDGHWDLOHGGHVFULSWLRQRISURFHGXUHVUHTXLUHGE\WKLV&,3

,QIRUPHG&RQVHQW3URFHVV
7KH3ULQFLSDO,QYHVWLJDWRURUKLVKHUDXWKRUL]HGGHVLJQHHZLOOFRQGXFWWKH,QIRUPHG&RQVHQW3URFHVVDV
UHTXLUHGE\DSSOLFDEOHUHJXODWLRQVDQGWKHFHQWHU¶V,5%(&7KLVSURFHVVZLOOLQFOXGHDYHUEDOGLVFXVVLRQ
ZLWKWKHVXEMHFWRQDOODVSHFWVRIWKHFOLQLFDOLQYHVWLJDWLRQWKDWDUHUHOHYDQWWRWKHVXEMHFW¶VGHFLVLRQWR
SDUWLFLSDWHVXFKDVGHWDLOVRIFOLQLFDOLQYHVWLJDWLRQSURFHGXUHVDQWLFLSDWHGEHQHILWVDQGSRWHQWLDOULVNVRI
FOLQLFDOLQYHVWLJDWLRQSDUWLFLSDWLRQ'XULQJWKHGLVFXVVLRQWKH3ULQFLSDO,QYHVWLJDWRURUKLVKHUDXWKRUL]HG
GHVLJQHHZLOODYRLGDQ\LPSURSHULQIOXHQFHRQWKHVXEMHFWDQGZLOOUHVSHFWVXEMHFW¶VOHJDOULJKWV7KHVXEMHFW
VKDOOEHSURYLGHGZLWKWKHLQIRUPHGFRQVHQWIRUPZULWWHQLQDODQJXDJHWKDWLVXQGHUVWDQGDEOHWRWKHVXEMHFW
DQG KDV EHHQ DSSURYHGE\ WKHFHQWHU¶V,5%(&7KHVXEMHFWVKDOO KDYH DGHTXDWHWLPHWRUHYLHZDVN
TXHVWLRQVDQGFRQVLGHUSDUWLFLSDWLRQ

,IWKHVXEMHFWDJUHHVWRSDUWLFLSDWHWKH,QIRUPHG&RQVHQWIRUPPXVWEHVLJQHGDQGGDWHGE\WKHVXEMHFW
DQGE\WKHSHUVRQREWDLQLQJWKHFRQVHQW7KHVLJQHGRULJLQDOZLOOEHILOHGLQWKHVXEMHFW¶VKRVSLWDORUUHVHDUFK
FKDUWVDQGDFRS\ZLOOEHSURYLGHGWRWKHVXEMHFW

7KH3ULQFLSDO,QYHVWLJDWRURUKLVKHUDXWKRUL]HGGHVLJQHHZLOOGRFXPHQWWKHLQIRUPHGFRQVHQWSURFHVVLQ
WKHVXEMHFW¶VKRVSLWDODQGRUUHVHDUFKFKDUWV7KHGDWHRIVLJQDWXUHZLOOEHHQWHUHGRQDQDSSOLFDEOH&DVH
5HSRUW)RUP&5)

)DLOXUHWRREWDLQLQIRUPHGFRQVHQWIURPDVXEMHFWSULRUWRFOLQLFDOLQYHVWLJDWLRQHQUROOPHQWVKRXOGEHUHSRUWHG
WR 6SRQVRU ZLWKLQ  ZRUNLQJ GD\V DQG WR WKH UHYLHZLQJ FHQWHU¶V ,5%(& DFFRUGLQJ WR WKH ,5%¶V (&¶V
UHSRUWLQJUHTXLUHPHQWV

,I GXULQJ WKH FOLQLFDO LQYHVWLJDWLRQ QHZ LQIRUPDWLRQ EHFRPHV DYDLODEOH WKDW FDQ VLJQLILFDQWO\ DIIHFW D
VXEMHFW
V IXWXUH KHDOWK DQG PHGLFDO FDUH WKH 3ULQFLSDO ,QYHVWLJDWRU RU KLVKHU DXWKRUL]HG GHVLJQHH ZLOO
SURYLGHWKLVLQIRUPDWLRQWRWKHVXEMHFW,IUHOHYDQWWKHVXEMHFWZLOOEHDVNHGWRFRQILUPWKHLUFRQWLQXLQJ
LQIRUPHGFRQVHQWLQZULWLQJ


6WXG\'RFXPHQW1R6-0&,39HU>&@
6WXG\1DPH'(/,9(5<
&OLQLFDO,QYHVWLJDWLRQ 3ODQ

7KLVFRQILGHQWLDOGRFXPHQWLVWKHSURSHUW\RI$EERWWDQGVKDOOQRWEHUHSURGXFHGGLVWULEXWHGGLVFORVHGRUXVHGZLWKRXWWKH
H[SUHVVZULWWHQFRQVHQWRI$EERWW
B&,37HPSODWHB5HYB&
3DJHRI
>5('$&7('@



6FUHHQLQJ
7KH3ULQFLSDO,QYHVWLJDWRURUGHOHJDWHGVWXG\SHUVRQQHOLVUHVSRQVLEOHIRUVFUHHQLQJDOOSRWHQWLDOSDWLHQWVWR
GHWHUPLQHSDWLHQWHOLJLELOLW\IRUWKHFOLQLFDOLQYHVWLJDWLRQ

,IDSDWLHQWPHHWVDOOLQFOXVLRQFULWHULDDQGGRHVQRWPHHWDQ\RIWKHH[FOXVLRQFULWHULDKHVKHLVHOLJLEOHIRU
WKHFOLQLFDOLQYHVWLJDWLRQ

5HFRUGVRISDWLHQWVZKRDUHVFUHHQHGPXVWEHPDLQWDLQHG

,QFDVHWKHVXEMHFWGRHVQRWPHHWDOOLQFOXVLRQFULWHULDRUPHHWVDQ\RIWKHH[FOXVLRQFULWHULDWKHVXEMHFWLV
FRQVLGHUHGDVFUHHQLQJIDLOXUH7KH3ULQFLSDO,QYHVWLJDWRURUWKHGHOHJDWHGVWXG\SHUVRQQHOZLOOUHFRUGWKH
VFUHHQLQJIDLOXUHLQWKHKRVSLWDOUHFRUGVDQGRQDVFUHHQLQJORJDVUHTXLUHG

3RLQWRI(QUROOPHQW
3DWLHQWVDUHFRQVLGHUHGHQUROOHGLQWKHFOLQLFDOLQYHVWLJDWLRQDQGEHFRPHVXEMHFWVIURPWKHPRPHQWWKH
SDWLHQWVKDYHSURYLGHGZULWWHQ3DWLHQW,QIRUPHG&RQVHQW

7KH3ULQFLSDO,QYHVWLJDWRURUGHOHJDWHGVWXG\SHUVRQQHOZLOOUHFRUGHQUROOPHQWLQIRUPDWLRQQDPHRIWKH
FOLQLFDO LQYHVWLJDWLRQ GDWH RI FRQVHQW DQG ,QFOXVLRQH[FOXVLRQ LQIRUPDWLRQ LQ WKH KRVSLWDO UHFRUGV DQG
FRPSOHWHDQGVXEPLWDQDSSOLFDEOH&5)LQDWLPHO\PDQQHU

1RWLILFDWLRQRIHQUROOPHQWWRWKH6SRQVRULVFRQVLGHUHGWRKDYHRFFXUUHGZKHQWKH6SRQVRUKDVUHFHLYHG
WKHDSSOLFDEOH&5)


6FKHGXOHG3URFHGXUHV
7KH3ULQFLSDO,QYHVWLJDWRULVUHVSRQVLEOHIRUHQVXULQJDOOFOLQLFDOLQYHVWLJDWLRQGDWDDUHFROOHFWHGDVUHTXLUHG
SHU&,3VFKHGXOHGSURFHGXUHV

7KHOLVWRIFOLQLFDOLQYHVWLJDWLRQVSHFLILFWHVWVDQGSURFHGXUHV7DEOHEHORZVXPPDUL]HYLVLWIORZDQG
UHTXLUHPHQWVRIWKLVFOLQLFDOLQYHVWLJDWLRQ

7DEOH/LVWRIDOOFOLQLFDOLQYHVWLJDWLRQVSHFLILFWHVWVDQGSURFHGXUHV



9LVLW











6WXG\$FWLYLW\
(QUROOPHQW%DVHOLQH
7ULDO6\VWHP,PSODQW
,QLWLDO7ULDO(YDOXDWLRQ3HULRG
6WDUW
(QGRI,QLWLDO7ULDO(YDOXDWLRQ
3HULRG
%HJLQ([WHQGHG7ULDO(YDOXDWLRQ
,IDSSOLFDEOH
(QGRI([WHQGHG7ULDO(YDOXDWLRQ
3HULRGLIDSSOLFDEOH
8QVFKHGXOHG9LVLW
,QIRUPHG&RQVHQW
;




6XEMHFW(OLJLELOLW\
;




'HPRJUDSKLFV3DLQ+LVWRU\	
'LDJQRVLV
;




1XPHULFDO5DWLQJ6FDOH
;

;
;


 
Study Document No: SJM-CIP-10116 Ver. [C] 
Study Name: DELIVERY 
 
Clinical Investigation Plan 
 
This confidential document is the property of Abbott and shall not be reproduced, distributed, disclosed or used without the 
express written consent of Abbott. 
86357_CIP Template_Rev_C 
Page 15 of 39 
                                             [REDACTED] 
 
 
PROMIS-29 
X 
 
 
 
 
Pain Catastrophizing Scale 
X 
 
 
 
 
Patient satisfaction and PRP 
 
 
X 
(X) 
 
Randomization 
X 
(X) 
 
 
 
Implant procedure and system data  
 
X 
 
 
 
Patient Trial Diary 
 
X 
X 
(X) 
 
Email Programming Details 
 
X 
X 
(X) 
(X) 
Stimulation Assessment 
 
X 
X 
(X) 
(X) 
Qualify for permanent implant 
 
 
X 
(X) 
 
Reason for Visit 
 
 
 
 
X 
Procedure Time 
 
X 
 
 
 
Programming Time 
 
X 
 
 
(X) 
Subject’s Feedback 
 
 
X 
 
 
Clinician Assessment 
 
X 
 
 
 
Physician’s Preference 
 
 
X* 
 
 
Imaging 
 
X 
X 
(X) 
(X) 
Lead Location 
 
X 
X 
(X) 
(X) 
SADEs, SAEs ADEs   
 
(X) 
(X) 
(X) 
(X) 
Deviation(s) 
(X) 
(X) 
(X) 
(X) 
(X) 
Withdrawal 
(X) 
(X) 
(X) 
(X) 
(X) 
Death 
(X) 
(X) 
(X) 
(X) 
(X) 
 
(X) If applicable 
* only after last subject’s last End of Initial Trial Period Visit- for a single site 
5.4.1 
Enrollment/Baseline Visit 
The following assessments and information will be collected at the baseline visit: 
• 
Demographics, pain history, pain diagnosis 
• 
Numerical Rating Scale (NRS) 
• 
Patient Reported Outcomes Measurement Information System-29 (PROMIS-29) 
• 
Pain Catastrophizing Scale (PCS) 
• 
Deviations (if applicable) 
• 
Withdrawal (if applicable)  
• 
Death (if applicable) 
5.4.2 
Randomization and Blinding 
Randomization may occur at the end of the baseline visit or just prior to surgery for trial system implant 
(Initial Trial Evaluation Period Start) Visit.  
 
Subjects will be randomized (1:1) using random permuted blocks of varying length and stratified by site. 
Subjects will be blinded to treatment group and treated in two groups as follows: 
 
1. Group 1 (AB): anatomic lead placement followed by BurstDR™ stimulation during initial trial 
evaluation period 
2. Group 2 (TB): targeted lead placement followed by BurstDR™ stimulation during initial trial 
evaluation period 
  
Randomization assignment will be communicated to the site via the Randomization Application available 
in the EDC Site Portal. 
 
Regardless of sedation, subjects will not be able to distinguish what implant technique (anatomic or 
targeted) is utilized without intimate knowledge of SCS programming, and with standardizing subject 

 
Study Document No: SJM-CIP-10116 Ver. [C] 
Study Name: DELIVERY 
 
Clinical Investigation Plan 
 
This confidential document is the property of Abbott and shall not be reproduced, distributed, disclosed or used without the 
express written consent of Abbott. 
86357_CIP Template_Rev_C 
Page 16 of 39 
                                             [REDACTED] 
 
 
interactions, the subjects will remain blinded to the treatment group. Implanting physicians and surgical 
support staff must follow the specific guidelines for the lead placement techniques and therefore cannot be 
blinded, but will be provided with a standardized script to assist with subject interaction as a way to minimize 
the risk of disclosing randomization assignments. Additionally, sites will be instructed to schedule study 
visits to restrict study subjects from being in the clinic at the same time, which aims to minimize subject to 
subject communication. Prior to study exit and before being unblinded, subjects will be asked about their 
memory for intra-operative testing as an assessment of the blind. Intra-operative testing is the key 
distinguishing feature between the techniques, so assessment of memory for experience will help to 
establish the status of the blind for each subject.   
 
A Blinding Plan will be maintained separately which will include a listing of all parties involved in the study 
to manage workflow and identification of blinded and unblinded information.   
5.4.3 
Trial System Implant (Initial Trial Evaluation Period Start) 
Record the required information on the applicable CRF: 
• 
Implant procedure and system data 
• 
Stimulation assessment 
• 
Clinician assessment 
• 
Procedure time 
• 
Programming time 
• 
Adverse events (if applicable) 
• 
Deviations (if applicable) 
• 
Withdrawal (if applicable) 
• 
Death (if applicable) 
 
Upload and attach the following documentation to the applicable CRF: 
• 
Images 
 
Device programming session records will be emailed directly to Abbott from the Clinician Programmer by 
Abbott personnel or designee in xml format to the following email address:  CDOUpload@sjm.com. 
 
The subject will complete a Patient Trial Diary once a day utilizing an application located on the Patient 
Controller during the trial evaluation period.  The subject will record areas of pain, stimulation therapy goals 
and percentage of pain relief in the diary.  At the end of the trial evaluation period, the End of Trial Summary 
report will be submitted to the sponsor. 
 
The following section of the protocol provides a guideline for surgical implantation and programming of the 
trial evaluation system.  
 
Lead Placement Technique: 
 
Anatomic lead placement (Randomization Group 1) 
 
Physicians may implant one or two leads as per their preference/standard of care at the site. Guidance for 
placement of the leads is provided below: 
 
Placement of 1 lead: 
 
▪ 
Lead 1 – Place lead tip at the rostral end of T8 segment 
▪ 
No tonic mapping/confirmation required 
▪ 
Confirm position using fluoroscopy (X-ray) and reposition lead if needed 
 

 
Study Document No: SJM-CIP-10116 Ver. [C] 
Study Name: DELIVERY 
 
Clinical Investigation Plan 
 
This confidential document is the property of Abbott and shall not be reproduced, distributed, disclosed or used without the 
express written consent of Abbott. 
86357_CIP Template_Rev_C 
Page 17 of 39 
                                             [REDACTED] 
 
 
Placement of 2 leads: 
 
▪ 
Lead 1 – Place lead tip at the rostral end of T8 segment 
▪ 
Lead 2 – Place lead tip at the rostral end of T9 segment 
▪ 
No tonic mapping/confirmation required 
▪ 
Confirm position using fluoroscopy (X-ray) and reposition lead if needed 
 
Targeted Lead Placement Technique (Randomization Group 2) 
 
▪ 
Physicians may implant one or two leads as per their preference/standard of care at the site 
▪ 
Utilize the standard lead placement technique as per standard of care for BurstDR stimulation.  
▪ 
Position lead(s) at the appropriate thoracic segment in the epidural space – dictated by pain 
coverage required by patient 
▪ 
Confirm adequate coverage of pain areas using tonic stimulation 
▪ 
Adjust lead position as needed to attain adequate coverage of pain areas  
 
Refer to Appendix D e.g. x-ray, fluoroscopy for additional requirements regarding imaging at the end of the 
lead placement procedure.   
 
Anchoring Technique: 
Securing the SCS leads during this investigation is critical to evaluate the anatomic versus targeted lead 
placement through the course of the trial period.  Acceptable methods to secure the leads include suturing 
and utilization of anchors. Methods that are not allowed during this investigation include include steri-strips 
and pre-manufactured bandages.   
 
Postoperative Programming: 
After the trial system implant procedure is complete, all subjects will be programmed with BurstDR™ 
stimulation programs by trained personnel and/or an Abbott representative using the Clinician Programmer. 
Subjects will be given a Patient Controller and instructed how to use the Patient Controller to adjust 
stimulation as needed to produce the best results and to complete the Patient Trial Diary daily during the 
trial evaluation period  
 
BurstDR™ Programming Guidelines can be found in Appendix C.  
 
During the initial trial evaluation period, the stimulation parameters may be optimized. If this is needed, the 
subject would return to the clinic for adjustments to the programming parameters. Study personnel 
performing programming activities will utilize the same methods as the post-op programming to ensure the 
subject remains blinded to treatment group. This visit should be documented as an unscheduled visit. If a 
lead revision is needed during the trial period, the subject should be withdrawn from the study. 
 
All device programming session records will be emailed directly to Abbott from the Clinician Programmer 
by Abbott personnel or designee in xml format to the following email address:  CDOUpload@sjm.com. 
5.4.4 
End of Initial Trial Evaluation Visit 
The initial trial evaluation period will be a minimum of 3 days. At the end of the initial trial evaluation period, 
the subject will be evaluated for qualification for permanent implant. If the subject qualifies for permanent 
implant, the subject will exit the study and continue their treatment per the physician’s standard of care. 
 
If the subject does not qualify for permanent system implant after a minimum of 5 days, the subject may be 
re-programmed with tonic stimulation, per physician discretion, and may enter the extended trial evaluation 
period. The extended evaluation period must continue for an additional minimum of 3 days.  
 

 
Study Document No: SJM-CIP-10116 Ver. [C] 
Study Name: DELIVERY 
 
Clinical Investigation Plan 
 
This confidential document is the property of Abbott and shall not be reproduced, distributed, disclosed or used without the 
express written consent of Abbott. 
86357_CIP Template_Rev_C 
Page 18 of 39 
                                             [REDACTED] 
 
 
Subjects will be re-programmed by trained personnel and/or an Abbott representative using the Clinician 
Programmer. Subjects will be instructed how to use the Patient Controller to adjust stimulation as needed 
to produce the best results and to complete the Patient Trial Diary daily during the extended trial evaluation 
period 
For subjects continuing with the extended trial evaluation period record the required information on the 
applicable CRF: 
• 
NRS 
• 
Patient satisfaction and PRP 
• 
Stimulation assessment 
• 
Subject’s feedback 
• 
Lead location 
• 
Physician preference (if applicable- only after End of Initial Trial Period Visit for the last 
subject for a single site) 
• 
Adverse events (if applicable) 
• 
Deviations (if applicable) 
• 
Withdrawal (if applicable) 
• 
Death (if applicable) 
• 
Qualify for permanent implant 
 
Device programming session records will be emailed directly to Abbott from the Clinician Programmer by 
Abbott personnel or designee in xml format to the following email address:  CDOUpload@sjm.com. 
 
Upload and attach the following documentation to the applicable CRF: 
• 
Images 
 
The subject will continue to complete the Patient Trial Diary daily during the extended trial evaluation period 
(if applicable).  The subject will record areas of pain, stimulation therapy goals and percentage of pain relief.  
At the end of the extended trial evaluation period, the End of Trial Summary report will be submitted to the 
sponsor. 
Subjects who do not continue with the extended trial evaluation will exit the study and continue their 
treatment per the physician’s standard of care. 
Record the required information on the applicable CRF: 
• 
NRS 
• 
Patient satisfaction and PRP 
• 
Stimulation assessment 
• 
Clinician assessment 
• 
Lead location 
• 
Adverse events (if applicable) 
• 
Deviations (if applicable) 
• 
Withdrawal (if applicable) 
• 
Death (if applicable) 
• 
Qualify for permanent implant 
 
Upload and attach the following documentation to the applicable CRF: 
• 
Images 
5.4.5 
End of Extended Trial Evaluation Period (if applicable) 
Subjects will return to the clinic at the end of the extended trial evaluation period, at which time the subject’s 
participation in the clinical investigation is completed regardless of qualification for permanent implant. 
Once the subject exits the study, the subject will continue their treatment per the physician’s standard of 
care.  
 


6WXG\'RFXPHQW1R6-0&,39HU>&@
6WXG\1DPH'(/,9(5<
&OLQLFDO,QYHVWLJDWLRQ 3ODQ

7KLVFRQILGHQWLDOGRFXPHQWLVWKHSURSHUW\RI$EERWWDQGVKDOOQRWEHUHSURGXFHGGLVWULEXWHGGLVFORVHGRUXVHGZLWKRXWWKH
H[SUHVVZULWWHQFRQVHQWRI$EERWW
B&,37HPSODWHB5HYB&
3DJHRI
>5('$&7('@


5HFRUGWKHUHTXLUHGLQIRUPDWLRQRQWKHDSSOLFDEOH&5)

156

3DWLHQWVDWLVIDFWLRQDQG353

6WLPXODWLRQDVVHVVPHQW

/HDG/RFDWLRQ

$GYHUVHHYHQWVLIDSSOLFDEOH

'HYLDWLRQVLIDSSOLFDEOH

:LWKGUDZDOLIDSSOLFDEOH

'HDWKLIDSSOLFDEOH

4XDOLI\IRUSHUPDQHQWLPSODQW

8SORDGDQGDWWDFKWKHIROORZLQJGRFXPHQWDWLRQWRWKHDSSOLFDEOH&5)

,PDJHV

'HYLFHSURJUDPPLQJVHVVLRQUHFRUGVZLOOEHHPDLOHGGLUHFWO\WR$EERWWIURPWKH&OLQLFLDQ3URJUDPPHUE\
$EERWWSHUVRQQHORUGHVLJQHHLQ[POIRUPDWWRWKHIROORZLQJHPDLODGGUHVV&'28SORDG#VMPFRP

'XULQJWKHH[WHQGHGWULDOHYDOXDWLRQSHULRGWKHVWLPXODWLRQSDUDPHWHUVPD\EHRSWLPL]HG,IWKLVLVQHHGHG
WKHVXEMHFWZRXOGUHWXUQWRWKHFOLQLFIRUDGMXVWPHQWVWRWKHSURJUDPPLQJSDUDPHWHUV

8QVFKHGXOHG9LVLWV
$QXQVFKHGXOHGYLVLWLVGHILQHGDVDQ\YLVLWZKHUHWKHVXEMHFWUHWXUQVWRWKHSDUWLFLSDWLQJVWXG\VLWHIRU
PHGLFDOFDUHRXWVLGHRIDVSHFLILHGVWXG\YLVLW5HDVRQVIRUXQVFKHGXOHGYLVLWVPD\LQFOXGHDQDGYHUVH
HYHQWZRXQGFKHFNRUSURJUDPPLQJFKDQJHQRWSURWRFROVSHFLILF

'XULQJWKHWULDOHYDOXDWLRQSHULRGVWKHVWLPXODWLRQSDUDPHWHUVPD\EHRSWLPL]HG,IWKLVLVQHHGHGWKH
VXEMHFWZRXOGUHWXUQWRWKHFOLQLFIRUDGMXVWPHQWVWRWKHSURJUDPPLQJSDUDPHWHUV

5HFRUGWKHUHTXLUHGLQIRUPDWLRQRQWKHDSSOLFDEOH&5)

5HDVRQIRUYLVLW

3URJUDPPLQJWLPHLIDSSOLFDEOH

/HDG/RFDWLRQLIDSSOLFDEOH

$GYHUVHHYHQWVLIDSSOLFDEOH

'HYLDWLRQVLIDSSOLFDEOH

:LWKGUDZDOLIDSSOLFDEOH

'HDWKLIDSSOLFDEOH

'HYLFHSURJUDPPLQJVHVVLRQUHFRUGVLIDSSOLFDEOHZLOOEHHPDLOHGGLUHFWO\WR$EERWWIURPWKH&OLQLFLDQ
3URJUDPPHU E\ $EERWW SHUVRQQHO RU GHVLJQHH LQ [PO IRUPDW WR WKH IROORZLQJ HPDLO DGGUHVV
&'28SORDG#VMPFRP

3DWLHQW5HSRUWHG2XWFRPH352PHDVXUHV
7KH6WXG\&RRUGLQDWRURUGHVLJQHHZLOOJLYHWKHVXEMHFWTXHVWLRQQDLUHWRFRPSOHWHRQKLVRUKHURZQRU
DSSO\ DQ LQWHUYLHZ WHFKQLTXH ,W LV LPSRUWDQW WKH VXEMHFW XQGHUVWDQGV WKH PHDQLQJ RI DOO ZRUGV DQG
LQVWUXFWLRQV LQ WKH TXHVWLRQQDLUHV 7KH VXEMHFW VKRXOG EH LQVWUXFWHG WR DVN DQ\ TXHVWLRQV DERXW WKH
TXHVWLRQQDLUHV LI IXUWKHU H[SODQDWLRQ LV QHHGHG 2QFH WKH TXHVWLRQQDLUHV DUH FRPSOHWHG WKH 6WXG\
&RRUGLQDWRURUGHVLJQHHZLOOUHYLHZIRUFRPSOHWHQHVVWRYHULI\WKDWDOOTXHVWLRQVKDYHEHHQDQVZHUHGDQG
RQO\RQHUHVSRQVHLVFKRVHQIRUHDFKTXHVWLRQXQOHVVRWKHUZLVHQRWHG

7KHIROORZLQJ352PHDVXUHVZLOOEHFROOHFWHGDFFRUGLQJWRWKHVWXG\UHTXLUHPHQWV


6WXG\'RFXPHQW1R6-0&,39HU>&@
6WXG\1DPH'(/,9(5<
&OLQLFDO,QYHVWLJDWLRQ 3ODQ

7KLVFRQILGHQWLDOGRFXPHQWLVWKHSURSHUW\RI$EERWWDQGVKDOOQRWEHUHSURGXFHGGLVWULEXWHGGLVFORVHGRUXVHGZLWKRXWWKH
H[SUHVVZULWWHQFRQVHQWRI$EERWW
B&,37HPSODWHB5HYB&
3DJHRI
>5('$&7('@



1XPHULFDO5DWLQJ6FDOH156
7KHSDLQ156FRQVLVWVRITXHVWLRQWKDWZLOOEHDVNHGE\LQWHUYLHZLQJWKHVXEMHFWV7KHVXEMHFWVZLOOEH
DVNHGWRUDWHWKHLUDYHUDJHSDLQVSHFLILFWRWKHDUHDVRIFKURQLFSDLQEHLQJWUHDWHGRYHUWKHSDVWKRXUV
RQDQRSDLQWRZRUVWLPDJLQDEOHSDLQVFDOH$KLJKHUVFRUHLQGLFDWHVDKLJKHUSDLQOHYHO7KH156
LVLPSOHPHQWHGLQWKH%DVHOLQH&5)WKH(QGRI,QLWLDO7ULDO(YDOXDWLRQ3HULRG&5)RUWKH(QGRI([WHQGHG
7ULDO(YDOXDWLRQ3HULRG&5)

3DWLHQW5HSRUWHG3DLQUHOLHI353
6XEMHFWVDUHDVNHGWRGLUHFWO\HVWLPDWHWKHSHUFHQWDJHRISDLQUHOLHIH[SHULHQFHGGXULQJWKHWULDOSHULRGIURP
QRSDLQUHOLHIWRWRWDOSDLQUHOLHIHJ³,KDYHSDLQUHOLHI´

,WHP$GXOW6FDOHRIWKH3DWLHQW5HSRUWHG2XWFRPHV0HDVXUHPHQW,QIRUPDWLRQ
6\VWHP3520,6'H\R5DPVD\%XFNOH\HWDO
7KH3520,6LVDQDGXOWVFDOHGHYHORSHGLQSDUWQHUVKLSZLWKWKH1DWLRQDO,QVWLWXWHVRI+HDOWK1,+WR
HVWLPDWHRYHUDOOTXDOLW\RIOLIHE\DVVHVVLQJWKHIROORZLQJGRPDLQVNQRZQWRLPSDFWDFWLYLWLHVRIGDLO\OLYLQJ
SK\VLFDOIXQFWLRQVOHHSGLVWXUEDQFHGHSUHVVLRQDQ[LHW\IDWLJXHSDLQ LQWHUIHUHQFH SDLQLQWHQVLW\DQG
VRFLDOUROHVDWLVIDFWLRQ7KHVFDOHUHTXLUHVVXEMHFWVWRUDWHWKHIUHTXHQF\DQGRUVHYHULW\RIV\PSWRPVDQG
H[SHULHQFHVUHODWHGWRHDFKRIWKHVHGRPDLQVDQXPHULFDOUDWLQJVFDOHIRUSDLQLQWHQVLW\LVLQFOXGHG
RQWKHVFDOH$WRWDOVFRUHLVFDOFXODWHGDQGWUDQVIRUPHGDJDLQVWQRUPDWLYHGDWDLQWRDWVFRUHLQGLFDWLQJ
JOREDOTXDOLW\RIOLIHLQUHODWLRQWRSRSXODWLRQQRUPV 6XEVFDOHVDUHGHILQHGE\HDFKGRPDLQGHVFULEHG
DERYH DQG FDQ EH H[DPLQHG VHSDUDWHO\ WR SDUVH VHSDUDWH V\PSWRPV RU GHILFLHQFLHV LQ TXDOLW\ RI OLIH
$GGLWLRQDOO\DQLPSDFWVFRUHIRUFKURQLFORZEDFNSDLQZDVGHYHORSHGE\WKH1,+5HVHDUFK7DVN)RUFH
'H\R'ZRUNLQ$PWPDQQHWDOZKLFKLVFRPSXWHGXVLQJWKHSDLQLQWHQVLW\SDLQLQWHUIHUHQFHDQG
SK\VLFDOIXQFWLRQVXEVFDOHV'DWDFDSWXUHGLQWKLVVFDOHFDQEHXVHGLQDYDULHW\RIZD\VWRHVWDEOLVKSDWLHQW
FKDUDFWHULVWLFVDQGWUDFNFKDQJHVRYHUWLPH

3DLQ&DWDVWURSKL]LQJ6FDOH3&66XOOLYDQ%LVKRS	3LYLN
7KH 3&6 LV D YDOLGDWHG VFDOH WKDW PHDVXUHV WKH PDJQLWXGH RI FDWDVWURSKL]LQJ QHJDWLYH WKRXJKWV DQG
IHHOLQJVZKLOHDSDWLHQWLVH[SHULHQFLQJSDLQ6XEMHFWVDQVZHUTXHVWLRQVDERXWKRZWKH\IHHODQGZKDWWKH\
WKLQNDERXW ZKHQWKH\ DUHLQSDLQLHQRW DWWKHFXUUHQWPRPHQW7KHVFDOHLQFOXGHVVWDWHPHQWV
FRQFHUQLQJSDLQH[SHULHQFHVWKDWDUHUDWHGRQDVFDOHEHWZHHQµQRWDWDOO¶DQGµDOZD\V¶7KHVFDOHLV
VHOIDGPLQLVWHUHGWDNHVPLQXWHVWRFRPSOHWHDQGH[DPLQHVWKHIROORZLQJWKUHHGRPDLQV5XPLQDWLRQ
0DJQLILFDWLRQDQG+HOSOHVVQHVV$KLJKHUVFRUHLQGLFDWHVDKLJKHUOHYHORIFDWDVWURSKL]LQJ7KH3&6LV
LPSOHPHQWHGLQWKH%DVHOLQH&5)

6WLPXODWLRQ$VVHVVPHQW
7KH 6WLPXODWLRQ $VVHVVPHQW )RUP LQFOXGHV TXHVWLRQV WR LGHQWLI\ WKH VHQVDWLRQV H[SHULHQFHG ZKHQ
VWLPXODWLRQLVXVHG6XEMHFWVLGHQWLI\WKHLQWHQVLW\DQGDUHDVRIVHQVDWLRQVLIH[SHULHQFHG,QWHQVLW\LVUDWHG
RQDVFDOHRIQRIHHOLQJWRYHU\LQWHQVH$PDSRIWKHERG\LVODEHOHG ZLWKGLIIHUHQWQXPEHUHG
TXDGUDQWVWR LGHQWLI\WKH DUHDVRIVHQVDWLRQV7KHVXEMHFW ZLOO EHUHTXHVWHGYLDLQWHUYLHZWHFKQLTXHWR
LQGLFDWHWKHDUHDKHVKHLVIHHOLQJVHQVDWLRQV7KHIRUPZLOOEHLPSOHPHQWHGDW7ULDO6\VWHP,PSODQW,QLWLDO
7ULDO(YDOXDWLRQ9LVLW&5)(QGRI,QLWLDO7ULDO(YDOXDWLRQ9LVLW&5)DQG(QGRI([WHQGHG7ULDO9LVLW&5)

&OLQLFLDQ$VVHVVPHQWV
7KHFOLQLFLDQDVVHVVPHQWRIWKHWZROHDGLPSODQWWHFKQLTXHVZLOOEHSHUIRUPHGDWWKHHQGRIHDFKWULDO
LPSODQWSURFHGXUHDQGDJDLQDWWKHHQGRIWKHVWXG\

$WWKHHQGRIHDFKWULDOLPSODQWSURFHGXUHFOLQLFLDQVZLOOEHDVNHGWRUDWHWKHPDJQLWXGHRIDQHVWKHVLD
UHODWHGGLIILFXOW\H[SHULHQFHGGXULQJWKHSURFHGXUHWKHPDJQLWXGHRIGLIILFXOW\LQSODFLQJWKHOHDGVDQG
WKHLUDIILQLW\OLNLQJIRUWKHWULDOLPSODQWSURFHGXUHSHUIRUPHGFRPSDUHGWRWKHLUXVXDOSUDFWLFH


6WXG\'RFXPHQW1R6-0&,39HU>&@
6WXG\1DPH'(/,9(5<
&OLQLFDO,QYHVWLJDWLRQ 3ODQ

7KLVFRQILGHQWLDOGRFXPHQWLVWKHSURSHUW\RI$EERWWDQGVKDOOQRWEHUHSURGXFHGGLVWULEXWHGGLVFORVHGRUXVHGZLWKRXWWKH
H[SUHVVZULWWHQFRQVHQWRI$EERWW
B&,37HPSODWHB5HYB&
3DJHRI
>5('$&7('@


$QHVWKHVLDUHODWHGGLIILFXOW\DQG/HDG3ODFHPHQWGLIILFXOW\ZLOOEHDVVHVVHGZLWKDLWHP/LNHUWVFDOHV
1R'LIILFXOW\/LWWOH'LIILFXOW\0RGHUDWH'LIILFXOW\6HYHUH'LIILFXOW\([WUHPH'LIILFXOW\±FRXOGQRWSODFH
OHDGV7RDVVHVVDIILQLW\OLNLQJFOLQLFLDQVZLOOEHDVNHG³2QDVFDOHIURPWRZLWKEHLQJµQRWDWDOO¶
DQGEHLQJµYHU\PXFK¶KRZPXFKGLG\RXOLNHWKLVWULDOLPSODQWSURFHGXUHFRPSDUHGWR\RXUXVXDO
FOLQLFDOSUDFWLFH´6FRUHVZLOOEHWUHDWHGDVPDJQLWXGHRI³OLNLQJ´IRUHDFKSURFHGXUHDQGZLOOEHWDEXODWHG
DVLQWHUYDOGDWD

$WWKHHQGRIWKHVWXG\FOLQLFLDQ¶VFRPSDUDWLYHSUHIHUHQFHIRURQHSURFHGXUHRYHUWKHRWKHUZLOOEH
DVVHVVHGWKLVZLOOVHUYHDVWKHVHFRQGDU\HQGSRLQW&OLQLFLDQVZLOOEHDVNHGWRFKRRVHHLWKHU³$QDWRPLF
/HDG3ODFHPHQW´RU³7DUJHWHG/HDG3ODFHPHQW´LQUHVSRQVHWRWKHIROORZLQJTXHVWLRQ³&RQVLGHULQJ\RXU
VXEMHFWV¶H[SHULHQFHVDQGRXWFRPHVDQG\RXUH[SHULHQFHVZLWKERWKOHDGSODFHPHQWWHFKQLTXHVZKLFK
WHFKQLTXHGR\RXSUHIHU"´

'HVFULSWLRQRI$FWLYLWLHV3HUIRUPHGE\6SRQVRU5HSUHVHQWDWLYHV
7UDLQHG6SRQVRUSHUVRQQHOZLOOSURYLGHWHFKQLFDOH[SHUWLVHDQGWHFKQLFDOJXLGDQFHRQWKHXVHRIWKH6&6
GHYLFHLQFOXGLQJWUDLQLQJDQGSURFWRUHGFDVHFRYHUDJH

:KLOH6SRQVRUUHSUHVHQWDWLYHVPD\SHUIRUPWKHVHDFWLYLWLHVWKH3ULQFLSDO,QYHVWLJDWRUUHPDLQVUHVSRQVLEOH
IRUHQVXULQJDOOFOLQLFDOLQYHVWLJDWLRQGDWDLVFROOHFWHGDVUHTXLUHGSHU&,3

6XEMHFW6WXG\&RPSOHWLRQ
:KHQWKHVXEMHFW¶VSDUWLFLSDWLRQLQWKHFOLQLFDOLQYHVWLJDWLRQKDVEHHQFRPSOHWHGWKHVXEMHFWZLOOUHWXUQWR
WKHPHGLFDOFDUHDVSHUSK\VLFLDQ¶VUHFRPPHQGDWLRQ
 6XEMHFW:LWKGUDZDO
6XEMHFWVPXVWEHLQIRUPHGDERXWWKHLUULJKWWRZLWKGUDZIURPWKHFOLQLFDOLQYHVWLJDWLRQDWDQ\WLPHDQGIRU
DQ\ UHDVRQ ZLWKRXW VDQFWLRQ SHQDOW\ RU ORVV RI EHQHILWV WR ZKLFK WKH VXEMHFW LV RWKHUZLVH HQWLWOHG
:LWKGUDZDOIURPWKHFOLQLFDOLQYHVWLJDWLRQZLOOQRWMHRSDUGL]HWKHLUIXWXUHPHGLFDOFDUHRUUHODWLRQVKLSZLWK
WKH LQYHVWLJDWRU 6XEMHFWV ZLOO EH UHTXHVWHG WR VSHFLI\ WKH UHDVRQ IRU WKH UHTXHVW WR ZLWKGUDZ 7KH
LQYHVWLJDWRU PXVW PDNH DOO UHDVRQDEOH HIIRUWV WR UHWDLQ WKH VXEMHFW LQ WKH FOLQLFDO LQYHVWLJDWLRQ XQWLO
FRPSOHWLRQRIWKHFOLQLFDOLQYHVWLJDWLRQ

([DPSOHVRIUHDVRQVIRUVXEMHFW¶VZLWKGUDZDOLQFOXGHEXWDUHQRWOLPLWHGWR


6XEMHFWDQGRUIDPLO\UHTXHVWWRZLWKGUDZFRQVHQW

6XEMHFWGHDWK

8QVXFFHVVIXOWULDOLPSODQWUHVXOWLQJLQLQHIIHFWLYHVWLPXODWLRQ

/HDGUHYLVLRQ

6\VWHPH[SODQW

7KHVWDWXVRIWKHVXEMHFW¶VFRQGLWLRQVKRXOGEHGRFXPHQWHGDWWKHWLPHRIZLWKGUDZDO
 6WXG\&RPPLWWHHV
 6WHHULQJ&RPPLWWHH6&
$ 6WHHULQJ &RPPLWWHH ZLOO DGYLVH WKH 6SRQVRU RQ NH\ DVSHFWV UHODWHG WR WKH GHYHORSPHQW H[HFXWLRQ
DQDO\VLVDQGUHSRUWLQJDQGRYHUDOOFRQGXFWRIWKHFOLQLFDOLQYHVWLJDWLRQ$6WHHULQJ&RPPLWWHHFKDUWHUZLOO
GHILQHPHPEHUVKLSRIWKHFRPPLWWHHDQGRXWOLQHWKHSXUSRVHUROHVUHVSRQVLELOLWLHVDQGJHQHUDOUXOHVRI
RSHUDWLRQ IRU WKH 6WHHULQJ &RPPLWWHH 7KLV FKDUWHU LV PDLQWDLQHG E\ WKH 6SRQVRU DQG VHWV IRUWK WKH
SURFHGXUHVIRUWKHLPSOHPHQWDWLRQRIWKH6WHHULQJ&RPPLWWHH


6WXG\'RFXPHQW1R6-0&,39HU>&@
6WXG\1DPH'(/,9(5<
&OLQLFDO,QYHVWLJDWLRQ 3ODQ

7KLVFRQILGHQWLDOGRFXPHQWLVWKHSURSHUW\RI$EERWWDQGVKDOOQRWEHUHSURGXFHGGLVWULEXWHGGLVFORVHGRUXVHGZLWKRXWWKH
H[SUHVVZULWWHQFRQVHQWRI$EERWW
B&,37HPSODWHB5HYB&
3DJHRI
>5('$&7('@



$0HGLFDO0RQLWRUZLOOEHXWLOL]HGIRUWKLVVWXG\7KH0HGLFDO0RQLWRULVUHVSRQVLEOHIRUUHYLHZLQJHDFK
VXEMHFW¶VOHDGSODFHPHQWLPDJLQJWRGHWHUPLQHLIWKHOHDGSODFHPHQWJXLGHOLQHVZHUHIROORZHG2QFHWKH
LQYHVWLJDWRUFRPSOHWHVWKHWULDOLPSODQWSURFHGXUHWKHLPDJHVDQGDSSOLFDEOHVRXUFHGRFXPHQWDWLRQZLOOEH
SURYLGHG WR WKH 0HGLFDO 0RQLWRU IRU HYDOXDWLRQ ,I WKH 0HGLFDO 0RQLWRU GHWHUPLQHV WKDW WKH SDWLHQW ZDV
LPSODQWHG RXWVLGH WKH UHTXLUHG JXLGHOLQHV D SURWRFRO GHYLDWLRQ ZLOO EH LVVXHG DQG WKH SDWLHQW ZLOO EH
H[FOXGHGIURPWKHSULPDU\HQGSRLQWDQDO\VLV

6WDWLVWLFDO&RQVLGHUDWLRQV
7KHIROORZLQJVHFWLRQGHVFULEHVWKHVWDWLVWLFDOPHWKRGVIRUWKHFOLQLFDOLQYHVWLJDWLRQDQGMXVWLILFDWLRQRIWKH
GHVLJQ

+\SRWKHVHV

3ULPDU\(QGSRLQW+\SRWKHVLV
7KHSULPDU\HQGSRLQWLVLQWHQGHGWRGHPRQVWUDWHQRQLQIHULRULW\RIWKHTXDOLILFDWLRQUDWHDWWKHHQGRIWKH
LQLWLDOWULDOHYDOXDWLRQSHULRGIRU*URXS$%FRPSDUHGWR*URXS7%

)RUHDFKUDQGRPL]DWLRQJURXSWKHTXDOLILFDWLRQUDWHLVGHILQHGDVWKHQXPEHURIVXEMHFWVZKRDUHLGHQWLILHG
DV³TXDOLILHGIRUSHUPDQHQWV\VWHPLPSODQW´GLYLGHGE\WRWDOVXEMHFWVZKRFRPSOHWHWKHLQLWLDOWULDOHYDOXDWLRQ
SHULRGIRUWKHUHVSHFWLYHUDQGRPL]HGJURXS

4XDOLILFDWLRQIRUSHUPDQHQWV\VWHPLPSODQWLVGHILQHGE\DFRPSRVLWHLQZKLFKDVXEMHFWPHHWVDOORIWKH
IROORZLQJFRQGLWLRQV

!SDWLHQWUHSRUWHGSDLQUHOLHI353DWWKHHQGRIWKHWULDOHYDOXDWLRQSHULRG

7ULDOHYDOXDWLRQSHULRGODVWHGIRUDPLQLPXPRIGD\V

3K\VLFLDQUHFRPPHQGVVXEMHFWIRUSHUPDQHQWV\VWHPLPSODQW

6XEMHFWUHSRUWVDZLOOLQJQHVVWRSXUVXHDSHUPDQHQWV\VWHPLPSODQW


6XEMHFWVDUHQRWTXDOLILHGIRUSHUPDQHQWV\VWHPLPSODQWLIWKH\PHHWERWKRIWKHIROORZLQJ

353DWWKHHQGRIWKHWULDOHYDOXDWLRQ

7ULDOHYDOXDWLRQSHULRGODVWHGIRUDPLQLPXPRIGD\V

+\SRWKHVLV
7KHK\SRWKHVLVLVIRUPDOO\DGGUHVVHGDV

+3$%37%

+3$%37%!

ZKHUH
3$% SHUPDQHQWV\VWHPTXDOLILFDWLRQUDWHRI*URXS$%
37% SHUPDQHQWV\VWHPTXDOLILFDWLRQUDWHRI*URXS7%

7KHOLWHUDWXUHUHSRUWVUDWHVRIFRQYHUVLRQIURPWULDOWRSHUPDQHQWLPSODQWXVLQJWRQLFVWLPXODWLRQUDQJLQJ
IURPWR$QRQLQIHULRULW\PDUJLQRILVVPDOOHUWKDQKDOIRIWKHORZHVWUHSRUWHGUDWHRI
FRQYHUVLRQIURPWULDOWRSHUPDQHQWLPSODQW$VVXPLQJDFRQYHUVLRQUDWHRIZKLFKLVPLGZD\WKURXJK
WKHUDQJHRIUDWHVUHSRUWHGDQRQLQIHULRULW\PDUJLQUHTXLUHVDQDWRPLFSODFHPHQWWREHDWOHDVW
ZKLFKLVDWWKHORZHUHQGRIWKHOLWHUDWXUHUHSRUWHGUDWHV

 
Study Document No: SJM-CIP-10116 Ver. [C] 
Study Name: DELIVERY 
 
Clinical Investigation Plan 
 
This confidential document is the property of Abbott and shall not be reproduced, distributed, disclosed or used without the 
express written consent of Abbott. 
86357_CIP Template_Rev_C 
Page 23 of 39 
                                             [REDACTED] 
 
 
6.1.1.1 
Analysis Methodology  
 
The hypothesis will be tested at the 5% significance level. The analysis will be carried out by calculating 
the 95% lower confidence bound (LCB) on the difference of permanent system qualification rates between 
Group 1 and Group 2 (i.e. PAB – PTB) using the Farrington-Manning method. The null hypothesis will be 
rejected if the 95% LCB for PAB – PTB is greater than -15%. 
 
6.1.1.2 
Sample Size Determination 
 
In the SJM Prodigy I PMCF trial and EMPOWER study, the observed qualification rates for tonic stimulation 
were 82.6% (100/121) and 58.8% (77/131), respectively, and the pooled tonic qualification rate was 70% 
(=177/252). Assuming that BurstDR™ stimulation qualification rate is similar to tonic stimulation, the sample 
size was calculated according to the assumption of qualification rates of 70% for BurstDR™ stimulation 
using either anatomic lead placement (Group 1) or targeted lead placement (Group 2). Under these 
assumptions, a sample size of 115 evaluable subjects for each arm would provide 80% power to reject the 
null hypothesis at 5% significance level. The sample size was estimated using PASS 13 (NCSS, LLC). 
 
6.1.1.3 
Analysis Populations 
 
The analysis population includes subjects who are randomized and either qualify for a permanent system 
implant or do not qualify for a permanent system implant, as defined earlier.   
6.1.1.4 
Subgroup Analysis 
 
The primary endpoint will be reported separately for female and male subjects.  
6.1.1.5 
 Missing Data 
 
A sensitivity analysis will be carried in the same manner as the primary analysis, except the subjects who 
were randomized, underwent the trial system implant and did not complete the initial trial period will be 
included in the analysis and be treated as non-qualified subjects. 
6.1.2 
Secondary Endpoint Hypothesis 
The secondary endpoint is intended to demonstrate physician preference for anatomic placement over 
targeted placement. 
 
Hypothesis: 
The hypothesis is formally addressed as: 
 
H0: P ≤ 60%  
 
H1: P > 60%   
 
where P= percentage of physician prefer anatomic placement over targeted placement. 
 
Analysis 
The hypothesis will be tested at the 5% significance level. The analysis population includes physicians who 
have performed both placement procedures. The analysis will be carried out by calculating the 95% LCB 
on the percentage of physicians who prefer anatomic placement over targeted placement (P) using the 
Clopper-Pearson exact method. The null hypothesis will be rejected if the 95% LCB for P is greater than 
60% (e.g., if the proportion of subjects is greater than that expected by chance, i.e., 50%).  


6WXG\'RFXPHQW1R6-0&,39HU>&@
6WXG\1DPH'(/,9(5<
&OLQLFDO,QYHVWLJDWLRQ 3ODQ

7KLVFRQILGHQWLDOGRFXPHQWLVWKHSURSHUW\RI$EERWWDQGVKDOOQRWEHUHSURGXFHGGLVWULEXWHGGLVFORVHGRUXVHGZLWKRXWWKH
H[SUHVVZULWWHQFRQVHQWRI$EERWW
B&,37HPSODWHB5HYB&
3DJHRI
>5('$&7('@



-XVWLILFDWLRQRI&OLQLFDO,QYHVWLJDWLRQ'HVLJQ
7RGDWHQRFOLQLFDOHYLGHQFHKDVEHHQJHQHUDWHGIRUWKHXVHRI%XUVW'5GXULQJWULDOHYDOXDWLRQIRU6&6RU
IRUWKH,QYLVLEOH7ULDO6\VWHPZLWKDQ\VWLPXODWLRQPRGH%XUVW'5XVHGZLWKSHUPDQHQW6&6V\VWHPVKDV
SURYLGHGEHWWHUSDWLHQWH[SHULHQFHVFRPSDUHGWRWRQLFVWLPXODWLRQHJSDLQUHOLHIDQGVDWLVIDFWLRQ7KH
WULDO V\VWHP FDSDEOH RI GHOLYHULQJ ERWK %XUVW'5 DQG WRQLF VWLPXODWLRQ PRGHV PD\ SURYLGH DGGLWLRQDO
EHQHILWVE\PDNLQJ%XUVW'5DYDLODEOHGXULQJWKHWULDOHYDOXDWLRQDQGE\SURYLGLQJDQDOWHUQDWLYHVWLPXODWLRQ
PRGH LI %XUVW'5 IDLOV )XUWKHUPRUH WKH ,QYLVLEOH 7ULDO 6\VWHP SURYLGHV D VWUHDPOLQHG ZLUHIUHH WULDO
H[SHULHQFHIRUVXEMHFWVDQGHVWDEOLVKLQJVXEMHFWLPSUHVVLRQVRIWKHV\VWHPDUHLQWHJUDOWRWKHPDUNHWLQJ
RIWKLVLPSURYHGV\VWHP

7KHSULPDU\DLPRIWKLVFOLQLFDOLQYHVWLJDWLRQLVWRHVWDEOLVKWKDWDQDWRPLFOHDGSODFHPHQWIRU%XUVW'5WULDOV
UHVXOWVLQQRQLQIHULRUTXDOLILFDWLRQUDWHVFRPSDUHGWRWKHWUDGLWLRQDOWDUJHWHGOHDGSODFHPHQWWHFKQLTXH7KH
DELOLW\WRDQDWRPLFDOO\SODFHWULDOOHDGVLVSRWHQWLDOO\LPSRUWDQWEHFDXVHLWVKRXOGUHGXFHSURFHGXUHWLPH
ZKLFK EHQHILWV ERWK SK\VLFLDQV DQG SDWLHQWV 3ULRU WR WKH DYDLODELOLW\ RI %XUVW'5 VWLPXODWLRQ DQDWRPLF
SODFHPHQWZDVQRWLQGLFDWHGGXHWRWKHVHQVRU\H[SHULHQFHVRIWRQLFVWLPXODWLRQ7KXVWKHFXUUHQWFOLQLFDO
LQYHVWLJDWLRQZLOOHVWDEOLVKWKHIHDVLELOLW\RIWKHDQDWRPLFSODFHPHQWSURFHGXUH$GGLWLRQDOO\HVWDEOLVKLQJ
WKHSK\VLFLDQ¶VSUHIHUHQFHRIDQDWRPLFSODFHPHQWDQGWKHHIIHFWRIDQDWRPLFSODFHPHQWRQSURFHGXUHWLPH
ZLOO LQIRUP FOLQLFDO FDUH  7KXV WKH FKRVHQ HQGSRLQWV FDSWXUH TXDOLILFDWLRQ UDWH SK\VLFLDQ SUHIHUHQFH
SURFHGXUHWLPHDQGGHVFULSWLYHLQIRUPDWLRQ$OORIWKHVHDUHGHVLJQHGWRH[SORUHSURFHGXUHEHQHILWVFOLQLFDO
H[SHULHQFHDQGSDWLHQWH[SHULHQFH

7ROLPLWNQRZOHGJHELDVWKLVFOLQLFDOLQYHVWLJDWLRQZLOOEHVLQJOHEOLQGHGLHVXEMHFWVZLOOQRWEHPDGHDZDUH
RIWKHJURXSWRZKLFKWKH\DUHUDQGRPL]HG$GGLWLRQDOO\DVWDQGDUGL]HGVFULSWZLOOEHSURYLGHGWRVWXG\
VLWHSHUVRQQHOWRDVVLVWZLWKSDWLHQWLQWHUDFWLRQDVDZD\WRPLQLPL]HWKHULVNRIGLVFORVLQJUDQGRPL]DWLRQ
DVVLJQPHQWV

7KHSULPDU\PDUNHURIVXFFHVVGXULQJWKHW\SLFDO6&6WULDOHYDOXDWLRQSHULRGLVTXDOLILFDWLRQIRUSHUPDQHQW
LPSODQW4XDOLILFDWLRQSHUVWDQGDUGRIFDUHIRU6&6GHYLFHVLQFOXGHVDVXFFHVVIXOWULDOHYDOXDWLRQSHULRG
GHILQHG E\ VXEMHFW¶V DVVHVVPHQW RI  RU PRUH SDLQ UHOLHI GXULQJ WKH WULDO HYDOXDWLRQ SK\VLFLDQ¶V
UHFRPPHQGDWLRQDQGWKHVXEMHFW¶VZLOOLQJQHVVWRFRQWLQXHWRWKHSHUPDQHQWV\VWHP$VVXFKWKHFXUUHQW
FOLQLFDO LQYHVWLJDWLRQ GHILQHV TXDOLILFDWLRQ IRU SHUPDQHQW LPSODQW DV D FRPSRVLWH HQGSRLQW EDVHG XSRQ
VWDQGDUGRIFDUHWREHXVHGDVIRUWKHSULPDU\HQGSRLQW'HPRQVWUDWLRQRIQRQLQIHULRULW\ZLOOHVWDEOLVKWKDW
WKHDQDWRPLFSODFHPHQWWHFKQLTXHLVVLPLODUWRWUDGLWLRQDOWDUJHWHGWHFKQLTXHVLQWHUPVRIVXEMHFWVHOHFWLRQ
IRUSHUPDQHQWLPSODQW6HFRQGDU\DQGGHVFULSWLYHHQGSRLQWVZLOOSURYLGHHYLGHQFHRIWKHSK\VLFLDQDQG
SDWLHQWH[SHULHQFHZLWKERWKW\SHVRILPSODQWSURFHGXUHVDQGZLWKWKH,QYLVLEOH7ULDO6\VWHPRYHUDOO

$VWKHSULPDU\K\SRWKHVLVZLOOEHWHVWHGSULRUWRDFWXDOSHUPDQHQWLPSODQWVWDWXVWKHFOLQLFDOLQYHVWLJDWLRQ
ZLOOHQGDWWKHTXDOLILFDWLRQVWDJHZLWKRXWFRQVLGHUDWLRQRIWKHDFWXDOSHUPDQHQWLPSODQWVWDWXVIRUVXEMHFWV
4XDOLILFDWLRQ EDVHG RQ HIILFDF\ VXEMHFW VHOIVHOHFWLRQ DQG SK\VLFLDQ GLVFUHWLRQ LV VXIILFLHQW WR PDNH
LQIHUHQFHVDERXWWKHDQDWRPLFSURFHGXUHDQG,QYLVLEOH7ULDO6\VWHPIHDWXUHV

)DLOXUHWRTXDOLI\IRUWKLVVWXG\LVFRQWLQJHQWXSRQDPLQLPXPRIGD\VRIVWLPXODWLRQ$QHFGRWDOUHSRUWV
LQGLFDWHGWKDWEXUVWVWLPXODWLRQPD\WDNHXSWRGD\VWRLPSDUWIXOOEHQHILWZKHUHDVWRQLFVWLPXODWLRQGRHV
QRWKLVWRULFDOO\KDYHDZDVKLQSHULRGWRUHDFKIXOOEHQHILW$VVXFKIDLOXUHVRFFXUULQJEHIRUHGD\VPD\
EHDSURGXFWRILQVXIILFLHQWH[SRVXUHWREXUVWWKHUDS\DQGWKHSULPDU\HQGSRLQWLVFRQWLQJHQWXSRQHTXLWDEOH
WUHDWPHQWEHWZHHQUDQGRPL]DWLRQDUPVLQDOORWKHUDVSHFWVH[FHSWLQJSURFHGXUH$GGLWLRQDOO\VXEMHFWVZKR
IDLOWKHEXUVWWULDODQGSURFHHGWRDQH[WHQGHGWULDOHYDOXDWLRQZLWKWRQLFVWLPXODWLRQZLOOQHHGWRHQVXUHWKDW
WKH\DUHSURYLGHGVXIILFLHQWWLPHWRDVVHVVWKHDOWHUQDWHVWLPXODWLRQPRGH$WSUHVHQWWKHZDVKRXWSHULRG
IRUEXUVWLIDQ\KDVQRWEHHQHVWDEOLVKHGEXWLVVXVSHFWHGWREHDWOHDVWDIHZKRXUVDQGXSWRGD\V$V
VXFK VXEMHFW¶V HQGLQJ WKHLU WULDO HYDOXDWLRQ EHIRUH  GD\V ZLWKRXW PHHWLQJ FULWHULD IRU TXDOLILFDWLRQ IRU
SHUPDQHQWLPSODQWZLOOEHFRQVLGHUHGDGHYLDWLRQDQGWUHDWHGDVPLVVLQJGDWD8VHRIWKLVFULWHULRQZLOODOVR


6WXG\'RFXPHQW1R6-0&,39HU>&@
6WXG\1DPH'(/,9(5<
&OLQLFDO,QYHVWLJDWLRQ 3ODQ

7KLVFRQILGHQWLDOGRFXPHQWLVWKHSURSHUW\RI$EERWWDQGVKDOOQRWEHUHSURGXFHGGLVWULEXWHGGLVFORVHGRUXVHGZLWKRXWWKH
H[SUHVVZULWWHQFRQVHQWRI$EERWW
B&,37HPSODWHB5HYB&
3DJHRI
>5('$&7('@


DOORZH[SORUDWRU\DQDO\VHVIRUSRWHQWLDOZDVKLQDQGZDVKRXWSHULRGVIRUEXUVWVWLPXODWLRQWKDWDUH\HWWR
EHHVWDEOLVKHGLQDFOLQLFDOVWXG\

0XOWLSOLFLW\
7KHUHLVRQHSULPDU\HQGSRLQWDQGRQHVHFRQGDU\HQGSRLQWRIWKLVFOLQLFDOLQYHVWLJDWLRQ7KHVHFRQGDU\
HQGSRLQWZLOOEHWHVWHGZKHQWKHSULPDU\HQGSRLQWLVPHW7KHUHIRUHQRPXOWLSOLFLW\DGMXVWPHQWLVQHHGHG

2YHUDOO6DPSOH6L]H
$VVXPLQJDWWULWLRQUDWHZKLFKDFFRXQWVIRUGURSRXWIURPFRQVHQWWRUDQGRPL]DWLRQDQGIURP
UDQGRPL]DWLRQWRFRQWULEXWLQJWRWKHDQDO\VLVSRSXODWLRQDVDPSOHVL]HRI VXEMHFWVZLOO
EHHQUROOHGDWXSWRVLWHVLQWKH(0($$1=&$DQG86UHJLRQV

'HVFULSWLYH(QGSRLQWV
'HVFULSWLYHHQGSRLQWVDUHUHSRUWHGXVLQJRQO\VXPPDU\VWDWLVWLFVDQGQRK\SRWKHVLVWHVWVZLOOEHSHUIRUPHG


 2YHUDOOSURFHGXUHWLPHLQURRPWRRXWURRPLPSODQWSURFHGXUHWLPHQHHGOHLQWRQHHGOHRXW
DQGWRWDOWLPHRILQWUDRSHUDWLYHIOXRURVFRS\H[SRVXUHIRUHDFKUDQGRPL]HGJURXSDQGVWUDWLILHGE\
QXPEHURIOHDGVDQGOHDGW\SHSHUPDQHQWOHDGRUWHPSRUDU\OHDG
 3URJUDPPLQJWLPHUHTXLUHGIRUHDFKUDQGRPL]HGJURXS
 &KDQJHIURPSUHLPSODQW1XPHULFDO5DWLQJ6FDOH156LQHDFKUDQGRPL]HGJURXSWRHQGRILQLWLDO
WULDOHYDOXDWLRQSHULRGDQGWRWKHHQGRIWKHH[WHQGHGWULDOHYDOXDWLRQSHULRGDVDSSOLFDEOH
 1XPEHURIVXEMHFWVLQHDFKUDQGRPL]HGJURXSZKRKDYHDIILUPDWLYHDVVHVVPHQWIRUHDFKRIWKH
LQGHSHQGHQWFULWHULDUHTXLUHGIRUTXDOLILFDWLRQIRUSHUPDQHQWLPSODQW
 3URSRUWLRQ RI VXEMHFWV LQ HDFK UDQGRPL]HG JURXS ZKR GR QRW TXDOLI\ IRU SHUPDQHQW LPSODQW
KRZHYHUGRSURFHHGZLWKSHUPDQHQWLPSODQWSHUSK\VLFLDQGLVFUHWLRQ
 7LPHIURPWULDOV\VWHPLPSODQWWR!353PHDVXUHGE\WKHQXPEHURIGD\VDOVRNQRZQDV
³ZDVKLQSHULRG´
 5DWHRIVHULRXVDGYHUVHGHYLFHHIIHFWV6$'(LQHDFKJURXS
 1XPEHUDQGSURSRUWLRQRIPHDQLQJIXOOHDGPLJUDWLRQVGXULQJWKHLQLWLDOWULDOHYDOXDWLRQSHULRGVE\
WUHDWPHQWJURXS
 1XPEHUDQGSURSRUWLRQRIPHDQLQJIXOOHDGPLJUDWLRQVGXULQJWKHLQLWLDOWULDOHYDOXDWLRQSHULRGLQ
VXEMHFWVZKRKDYHDWHPSRUDU\WULDOOHDGLPSODQWFRPSDUHGWRVXEMHFWVZKRKDYHDSHUPDQHQWWULDO
OHDGLPSODQW
&OLQLFLDQDVVHVVPHQWRIDQHVWKHVLDUHODWHGGLIILFXOW\DVVHVVHGSULPDULO\LQWKHSURFHGXUHURRPIRU
WKHWULDORQDSRLQWOLNHUWVFDOHIRUHDFKUDQGRPL]HGJURXS
&OLQLFLDQDVVHVVPHQWRIOHDGSODFHPHQWGLIILFXOW\RQDSRLQWOLNHUWVFDOHIRUHDFKUDQGRPL]HG
JURXS
&OLQLFLDQDIILQLW\OLNLQJIRUOHDGSODFHPHQWWHFKQLTXHDWWKHHQGRIWKHWULDOLPSODQWSURFHGXUH
3HUPDQHQWV\VWHPTXDOLILFDWLRQUDWHDWWKHHQGRIH[WHQGHGWULDOSHULRG

$PHDQLQJIXOOHDGPLJUDWLRQLVGHILQHGDVDOHDGPLJUDWLRQUHVXOWLQJLQWKHLQDELOLW\WRSURJUDPIRUWKHUDSHXWLF
UHVSRQVH

7LPLQJRI$QDO\VLV
$QDO\VLVZLOOEHSHUIRUPHGZKHQWKHODVWHQUROOHGVXEMHFWFRPSOHWHVWKHLQLWLDOWULDOHYDOXDWLRQRULIVXEMHFW
IDLOHGWRTXDOLI\GXULQJWKHLQLWLDOWULDOHYDOXDWLRQSHULRGDQGSDUWLFLSDWHGLQWKHH[WHQGHGWULDOSHULRGDIWHU
FRPSOHWLRQRIWKHH[WHQGHGWULDOSHULRG


6WXG\'RFXPHQW1R6-0&,39HU>&@
6WXG\1DPH'(/,9(5<
&OLQLFDO,QYHVWLJDWLRQ 3ODQ

7KLVFRQILGHQWLDOGRFXPHQWLVWKHSURSHUW\RI$EERWWDQGVKDOOQRWEHUHSURGXFHGGLVWULEXWHGGLVFORVHGRUXVHGZLWKRXWWKH
H[SUHVVZULWWHQFRQVHQWRI$EERWW
B&,37HPSODWHB5HYB&
3DJHRI
>5('$&7('@



6XFFHVV&ULWHULD
7KHFOLQLFDOLQYHVWLJDWLRQZLOOEHFRQVLGHUHGDVXFFHVVZKHQWKHSULPDU\HQGSRLQWLVPHW

,QWHULP$QDO\VLV
1RLQWHULPDQDO\VHVDUHSODQQHGIRUWKLVVWXG\

6WDWLVWLFDO&ULWHULDIRU7HUPLQDWLRQ
7KHUHDUHQRVWDWLVWLFDOFULWHULDIRUWHUPLQDWLRQRIWKLVFOLQLFDOLQYHVWLJDWLRQ
 'HYLDWLRQVIURP6WDWLVWLFDO3ODQ
,IDQ\GHYLDWLRQVIURPWKHRULJLQDOVWDWLVWLFDOSODQRFFXUVXFKGHYLDWLRQVZLOOEHGRFXPHQWHGLQWKHFOLQLFDO
VWXG\UHSRUWRUVWDWLVWLFDOUHSRUWFRQWDLQLQJWKHDQDO\VLVUHVXOWV

5LVNVDQG%HQHILWV
7KHULVNVDVVRFLDWHGZLWKWKHXVHRIWKHµ,QYLVLEOH7ULDO6\VWHP¶DUHDQWLFLSDWHGWREHFRPSDUDEOHWRWKRVH
DVVRFLDWHGZLWKWKHXVHRIRWKHUFXUUHQWO\DYDLODEOH6&6WULDOV\VWHPV6XEMHFWVSDUWLFLSDWLQJLQWKLVVWXG\
DUHLQGLFDWHGIRUDQ6&6WULDOQHXURPRGXODWLRQV\VWHPDVSDUWRIWKHLUVWDQGDUGPHGLFDOPDQDJHPHQWDQG
DUHVXEMHFWWRWKHULVNDVVRFLDWHGZLWKWKHXVHRIWKHVHGHYLFHV7KHVWXG\GRHVQRWUHTXLUHDQ\DGGLWLRQDO
SURFHGXUHVRUDVVHVVPHQWVRYHUWKHVWDQGDUGRIFDUH
7KLVVWXG\PD\RUPD\QRWEHQHILWWKHVXEMHFWVLQYROYHGEXWPD\KHOSIXWXUHVXEMHFWVE\LQFUHDVLQJFXUUHQW
NQRZOHGJH DQG XQGHUVWDQGLQJ RI WUHDWPHQW RSWLRQV IRU VXEMHFWV ZKR DUH LQGLFDWHG IRU WKH WULDO
QHXURPRGXODWLRQV\VWHPIRU6&6
/HDGSODFHPHQWIRU%XUVW'5KDVSURFHHGHGWRXVHWHPSRUDU\WRQLFVWLPXODWLRQVXFKWKDWWKHVHQVRU\
TXDOLWLHVRIWRQLFSURJUDPPLQJSDUHVWKHVLDVFDQEHXVHGWRHOLFLWIHHGEDFNIURPSDWLHQWVDQGHQVXUHWKH
OHDGVDUHSURSHUO\SODFHGDQGSURJUDPPHG%HFDXVH%XUVW'5UHVXOWVLQVHQVDWLRQIUHHWKHUDS\IRUPRVW
SDWLHQWVLWKDVEHHQSURSRVHGWKDWDQDWRPLFSODFHPHQWRIWKHOHDGVFRXOGUHVXOWLQHIIHFWLYHWKHUDS\ZKLOH
UHGXFLQJSURFHGXUHWLPHVGXULQJERWKWKHWULDOHYDOXDWLRQDQGSHUPDQHQWV\VWHPLPSODQWV7KLVEHQHILWPD\
EHDSSOLFDEOHIRUVXEMHFWVUDQGRPL]HGWR*URXS$%

5LVNV$VVRFLDWHGZLWKWKH'HYLFH8QGHU,QYHVWLJDWLRQ
7KHUHDUHQRDGGLWLRQDOULVNVWRWKHVWXG\VXEMHFWVEH\RQGWKRVHDVVRFLDWHGZLWKWKHLPSODQWDQGXVHRIWKH
DSSURYHGWULDOQHXURPRGXODWLRQV\VWHPV3OHDVHUHIHUWRVHFWLRQIRUWKHOLVWRIDQWLFLSDWHGDGYHUVH
HYHQWV

$QWLFLSDWHG$GYHUVH'HYLFH(IIHFWV
7KHLPSODQWDWLRQRID6&6WULDOV\VWHPLVDQLQYDVLYHSURFHGXUHDQGWKHUHIRUHFDUULHVFHUWDLQULVNV,Q
DGGLWLRQWRWKRVHULVNVFRPPRQO\DVVRFLDWHGZLWKVXUJHU\WKHIROORZLQJDQWLFLSDWHGDGYHUVHGHYLFHHIIHFWV
DUHDVVRFLDWHGZLWKLPSODQWLQJRUXVLQJWKHWULDOQHXURPRGXODWLRQV\VWHPIRU6&6

x
8QSOHDVDQWVHQVDWLRQVRUPRWRUGLVWXUEDQFHVLQFOXGLQJLQYROXQWDU\PRYHPHQWFDXVHGE\
VWLPXODWLRQDWKLJKRXWSXWV,IHLWKHURFFXUVWXUQRIIWKH(3*LPPHGLDWHO\
x
8QGHVLUDEOHFKDQJHVLQVWLPXODWLRQZKLFKPD\EHUHODWHGWRFHOOXODUFKDQJHVLQWLVVXHDURXQGWKH
HOHFWURGHVFKDQJHVLQHOHFWURGHSRVLWLRQORRVHHOHFWULFDOFRQQHFWLRQVRUOHDGIDLOXUH
x
6WLPXODWLRQLQXQZDQWHGSODFHV
x
/HDGPLJUDWLRQFDXVLQJFKDQJHVLQVWLPXODWLRQRUUHGXFHGSDLQUHOLHI
x
(SLGXUDOKHPRUUKDJH
x
+HPDWRPD
x
,QIHFWLRQ


6WXG\'RFXPHQW1R6-0&,39HU>&@
6WXG\1DPH'(/,9(5<
&OLQLFDO,QYHVWLJDWLRQ 3ODQ

7KLVFRQILGHQWLDOGRFXPHQWLVWKHSURSHUW\RI$EERWWDQGVKDOOQRWEHUHSURGXFHGGLVWULEXWHGGLVFORVHGRUXVHGZLWKRXWWKH
H[SUHVVZULWWHQFRQVHQWRI$EERWW
B&,37HPSODWHB5HYB&
3DJHRI
>5('$&7('@


x
6SLQDOFRUGFRPSUHVVLRQ
x
3DUDO\VLVIURPSODFHPHQWRIDOHDGLQWKHHSLGXUDOVSDFH
x
&HUHEURVSLQDOIOXLG&6)OHDNDJH
x
3DUDO\VLV
x
:HDNQHVVFOXPVLQHVVQXPEQHVVRUSDLQEHORZWKHOHYHORIWKHLPSODQW
x
$OOHUJLFRUUHMHFWLRQUHVSRQVHWRLPSODQWPDWHULDOV
x
6HURPDPDVVRUVZHOOLQJDWWKHLPSODQWVLWH
x
/RFDOVNLQHURVLRQ
x
3HUVLVWHQWSDLQDWOHDGVLWH

5LVNV$VVRFLDWHGZLWK&OLQLFDO,QYHVWLJDWLRQ$VVHVVPHQWV
7KHULVNVLQYROYHGZLWKWKLVFOLQLFDOLQYHVWLJDWLRQDUHFRPSDUDEOHWRWKRVHDVVRFLDWHGZLWKWKHLPSODQWRIDQ\
RWKHUFRPPHUFLDOO\DYDLODEOHQHXURPRGXODWLRQV\VWHP

5LVN&RQWURO0HDVXUHV
(YHU\SRVVLEOHHIIRUWZLOOEHWDNHQWRPLQLPL]HWKHULVNVLQFOXGLQJ
x
&DUHIXOVHOHFWLRQRIH[SHULHQFHG,QYHVWLJDWRUVIRUWKHFOLQLFDOLQYHVWLJDWLRQ
x
$GHTXDWHPRQLWRULQJIRUHDFKFOLQLFDOLQYHVWLJDWLRQVLWH
x
&RQGXFWLQJWKHFOLQLFDOLQYHVWLJDWLRQLQDFFRUGDQFHZLWKWKH&,3DOODSSOLFDEOHODZVDQG
UHJXODWLRQVDQGDQ\FRQGLWLRQVRIDSSURYDOLPSRVHGE\WKHDSSURSULDWH,5%(&RUDSSOLFDEOH
UHJXODWRU\DXWKRULWLHVZKHUHWKHFOLQLFDOLQYHVWLJDWLRQLVSHUIRUPHG
x
7UDLQLQJRI,QYHVWLJDWRUVERWKRQWKH&,3OHDGSODFHPHQWSURFHGXUHDQFKRULQJWHFKQLTXHDQG
LPDJLQJJXLGHOLQHV

3RVVLEOHLQWHUDFWLRQVZLWKFRQFRPLWDQWWUHDWPHQWV
7KHUHDUHQRNQRZQLQWHUDFWLRQVRIWKHQHXURPRGXODWLRQWULDOV\VWHPZLWKFRQFRPLWDQWPHGLFDOWUHDWPHQW
RU ZLWK DQ\ SUHYLRXVO\ LPSODQWHG DFWLYH GHYLFHV 3OHDVH UHIHU WR WKH &OLQLFLDQ¶V 0DQXDO IRU WKH 6-070
([WHUQDO3XOVH*HQHUDWRUDQGOHDGVIRULQIRUPDWLRQUHODWHGWR05,FRPSDWLELOLW\

5LVNWR%HQHILW5DWLRQDOH
$Q\XQGHVLUDEOHVLGHHIIHFWVXQGHUQRUPDOFRQGLWLRQVRIXVHDUHFRQVLGHUHGWREHDFFHSWDEOHULVNVZKHQ
ZHLJKHGDJDLQVWWKHSHUIRUPDQFHRIWKHGHYLFHDQGEHQHILWVWRWKHVXEMHFW

5HTXLUHPHQWVIRU,QYHVWLJDWRU5HFRUGVDQG5HSRUWV

'HYLDWLRQVIURP&,3
$GHYLDWLRQLVGHILQHGDVDQLQVWDQFHVRIIDLOXUHWRIROORZLQWHQWLRQDOO\RUXQLQWHQWLRQDOO\WKHUHTXLUHPHQWV
RIWKH&,37KHLQYHVWLJDWRUVKRXOGQRWGHYLDWHIURPWKH&,3

,QVRPHFDVHVIDLOXUHWRFRPSO\ZLWKWKH&,3PD\EHFRQVLGHUHGIDLOXUHWRSURWHFWWKHULJKWVVDIHW\DQG
ZHOOEHLQJRIVXEMHFWVVXFKQRQFRPSOLDQFHH[SRVHVVXEMHFWVWRXQUHDVRQDEOHULVNV([DPSOHVIDLOXUHWR
DGKHUHWRWKHLQFOXVLRQH[FOXVLRQFULWHULDIDLOXUHWRSHUIRUPVDIHW\DVVHVVPHQWVLQWHQGHGWRGHWHFWDGYHUVH
HYHQWV,QYHVWLJDWRUVVKRXOGVHHNWRPLQLPL]HVXFKULVNVE\DGKHULQJWRWKH&,3

7KH3,PXVWPDLQWDLQDFFXUDWHFRPSOHWHDQGFXUUHQWUHFRUGVLQFOXGLQJGRFXPHQWVVKRZLQJWKHGDWHRI
DQGUHDVRQIRUHDFKGHYLDWLRQIURPWKH&,35HOHYDQWLQIRUPDWLRQIRUHDFKGHYLDWLRQZLOOEHGRFXPHQWHGDV
VRRQDVSRVVLEOHRQWKHDSSOLFDEOH&5)7KHVLWHZLOOVXEPLWWKH&5)WRWKH6SRQVRU

7KH3,LVUHTXLUHGWRDGKHUHWRORFDOUHJXODWRU\UHTXLUHPHQWVIRUUHSRUWLQJGHYLDWLRQVWR,5%(&


6WXG\'RFXPHQW1R6-0&,39HU>&@
6WXG\1DPH'(/,9(5<
&OLQLFDO,QYHVWLJDWLRQ 3ODQ

7KLVFRQILGHQWLDOGRFXPHQWLVWKHSURSHUW\RI$EERWWDQGVKDOOQRWEHUHSURGXFHGGLVWULEXWHGGLVFORVHGRUXVHGZLWKRXWWKH
H[SUHVVZULWWHQFRQVHQWRI$EERWW
B&,37HPSODWHB5HYB&
3DJHRI
>5('$&7('@



8QGHUHPHUJHQF\FLUFXPVWDQFHVGHYLDWLRQVIURPWKH&,3WRSURWHFWWKHULJKWVVDIHW\DQGZHOOEHLQJRI
VXEMHFWVPD\SURFHHGZLWKRXWSULRUDSSURYDORIWKH6SRQVRUDQGWKH,5%(&6XFKGHYLDWLRQVVKDOOEH
GRFXPHQWHGDQGUHSRUWHGWRWKH6SRQVRUDQGWKH,5%(&DVVRRQDVSRVVLEOH

6DIHW\5HSRUWLQJ
6DIHW\VXUYHLOODQFHDQGVDIHW\UHSRUWLQJE\WKHLQYHVWLJDWRUVWDUWVDVVRRQDVWKHVXEMHFWLVHQUROOHGLQWKLV
FOLQLFDOLQYHVWLJDWLRQGDWHRIVLJQDWXUHRILQIRUPHGFRQVHQW

7KHVDIHW\VXUYHLOODQFHDQGWKHVDIHW\UHSRUWLQJZLOOFRQWLQXHXQWLOWKHODVWLQYHVWLJDWLRQDOYLVLWKDVEHHQ
SHUIRUPHGWKHVXEMHFWLVGHFHDVHGWKHVXEMHFWLQYHVWLJDWRUFRQFOXGHVKLVSDUWLFLSDWLRQLQWRWKHFOLQLFDO
LQYHVWLJDWLRQRUWKHVXEMHFWZLWKGUDZDOIURPWKHFOLQLFDOLQYHVWLJDWLRQ

3HUWKLV&,3WKHDSSOLFDEOHUHSRUWDEOHDGYHUVHHYHQWVGDWDLQFOXGLQJGHDWKVZLOOEHFROOHFWHGWKURXJKRXW
WKHFOLQLFDOLQYHVWLJDWLRQDQGZLOOEHUHSRUWHGWRWKH6SRQVRUWKURXJKWKH('&V\VWHP7KH6SRQVRUZLOO
HQVXUH WKDW DOO DSSOLFDEOH HYHQWV DUH UHSRUWHG WR WKH UHOHYDQW DXWKRULWLHV DV SHU UHJXODWLRQV 7KH
LQYHVWLJDWRUVPXVWQRWLI\WKH,5%(&LIDSSURSULDWHLQDFFRUGDQFHZLWK WKHLULQVWLWXWLRQDOUHTXLUHPHQWV
QDWLRQDODQGORFDOODZVDQGUHJXODWLRQVRIWKH$(VUHSRUWHGWRWKH6SRQVRU

$GYHUVH HYHQWV ZLOO EH PRQLWRUHG XQWLO WKH\ DUH DGHTXDWHO\ UHVROYHG RU WKH VXEMHFW KDV HQGHG KLVKHU
SDUWLFLSDWLRQLQWKHFOLQLFDOLQYHVWLJDWLRQZKLFKHYHUFRPHVILUVW7KHVWDWXVRIWKHVXEMHFW¶VFRQGLWLRQVKRXOG
EHGRFXPHQWHGDWHDFKYLVLW

'HVFULSWLYHHQGSRLQWVIRUWKHVDIHW\GDWDSRLQWVDUHDVIROORZV

5DWHRIVHULRXVDGYHUVHGHYLFHHIIHFWV6$'(LQHDFKJURXS

1XPEHUDQGSURSRUWLRQRIPHDQLQJIXOOHDGPLJUDWLRQVGXULQJWKHLQLWLDOWULDOHYDOXDWLRQSHULRGVE\
WUHDWPHQWJURXS

1XPEHUDQGSURSRUWLRQRIPHDQLQJIXOOHDGPLJUDWLRQVGXULQJWKHLQLWLDOWULDOHYDOXDWLRQSHULRGVLQ
VXEMHFWVZKRKDYHDWHPSRUDU\WULDOOHDGLPSODQWFRPSDUHGWRVXEMHFWVZKRKDYHDSHUPDQHQWWULDO
OHDGLPSODQW
$ PHDQLQJIXO OHDG PLJUDWLRQ LV GHILQHG DV D OHDG PLJUDWLRQ UHVXOWLQJ LQ WKH LQDELOLW\ WR SURJUDP IRU
WKHUDSHXWLFUHVSRQVH

)RUWKHSXUSRVHVRIWKLVFOLQLFDOLQYHVWLJDWLRQWKHIROORZLQJHYHQWVZLOOEHUHSRUWHG

x
$OO$GYHUVH'HYLFH(IIHFWVQRQVHULRXVGHYLFHSURFHGXUHUHODWHG
x
$OO6HULRXV$GYHUVH(YHQWVZKHWKHURUQRWWKHHYHQWLVFRQVLGHUHGGHYLFHSURFHGXUHUHODWHG

5HSRUWDEOHDGYHUVHHYHQWVVKDOOEHVXEPLWWHGWRWKH6SRQVRUDVVRRQDVSRVVLEOHDIWHUEHFRPLQJDZDUHRI
WKHHYHQW7KHVLWHVVKRXOGQRWLI\WKH6SRQVRURIUHSRUWDEOHDGYHUVHHYHQWVE\FUHDWLQJDQGVDYLQJWKH
DSSOLFDEOH&5)ZLWKLQWKHHOHFWURQLFGDWDFDSWXUH('&V\VWHP$GGLWLRQDOLQIRUPDWLRQPD\EHUHTXHVWHG
E\WKH6SRQVRULQRUGHUWRVXSSRUWWKHUHSRUWLQJRI$(VWRUHJXODWRU\DXWKRULWLHV$OODGYHUVHHYHQWVZLOOEH
UHSRUWHGDVSHUDSSOLFDEOHUHJXODWRU\UHTXLUHPHQWV
6XEMHFW'HDWK
6XEMHFWGHDWKVZLOOEHGRFXPHQWHGDQGUHSRUWHGWRWKH6SRQVRURQWKHDSSOLFDEOH&5)DVVRRQDVSRVVLEOH
DIWHUEHFRPLQJDZDUHRIWKHHYHQW,WLVWKHLQYHVWLJDWRU¶VUHVSRQVLELOLW\WRQRWLI\WKH,5%(&RIWKHGHDWK
UHSRUWHGWR6SRQVRULQDFFRUGDQFHZLWKQDWLRQDODQGORFDOODZVDQGUHJXODWLRQV

6KRXOGDGHDWKRFFXUWKHLQYHVWLJDWRULVUHTXHVWHGWRUHFRUGGHDWKLQIRUPDWLRQLQWKHKRVSLWDOUHFRUGVDQG
LPPHGLDWHO\GRFXPHQWWKHLQIRUPDWLRQRQWKH'HDWK&5)DQGVXEPLWWR6SRQVRUWKURXJKWKHHOHFWURQLF
GDWDFDSWXUH('&V\VWHPGHSOR\HGE\$EERWW



6WXG\'RFXPHQW1R6-0&,39HU>&@
6WXG\1DPH'(/,9(5<
&OLQLFDO,QYHVWLJDWLRQ 3ODQ

7KLVFRQILGHQWLDOGRFXPHQWLVWKHSURSHUW\RI$EERWWDQGVKDOOQRWEHUHSURGXFHGGLVWULEXWHGGLVFORVHGRUXVHGZLWKRXWWKH
H[SUHVVZULWWHQFRQVHQWRI$EERWW
B&,37HPSODWHB5HYB&
3DJHRI
>5('$&7('@


x
$OOHIIRUWVWRREWDLQWKHGHWDLOVDERXWWKHFLUFXPVWDQFHVVXUURXQGLQJWKHSDWLHQWGHDWKVKRXOG
EHPDGHE\WKH,QYHVWLJDWRU
x
,IDGHDWKHYHQWLVDQRXWFRPHRIDQDGYHUVHHYHQWDQ$(&5)PXVWEHFRPSOHWHGLQDGGLWLRQ
WRWKH'HDWK&5)

7KH VXEMHFW¶V GHDWK LV DQ HDUO\ FRQFOXVLRQ RI WKH VXEMHFW¶V SDUWLFLSDWLRQ LQ WKH FOLQLFDO LQYHVWLJDWLRQ
7KHUHIRUHWKH,QYHVWLJDWRULVUHTXHVWHGWRFRPSOHWHWKH:LWKGUDZDOIRUP

&RPSODLQWV'HYLFH'HILFLHQFLHV
'XULQJWKHVWXG\WKHLQYHVWLJDWRUZLOOEHUHVSRQVLEOHIRUUHSRUWLQJDOOFRPSODLQWVGHYLFHGHILFLHQFLHV
$FRPSODLQWLVGHILQHGDVDQ\ZULWWHQHOHFWURQLFRURUDOFRPPXQLFDWLRQWKDWDOOHJHVGHILFLHQFLHVUHODWHGWR
WKHLGHQWLW\TXDOLW\GXUDELOLW\UHOLDELOLW\VDIHW\HIIHFWLYHQHVVRUSHUIRUPDQFHRIDGHYLFHDIWHULWLVUHOHDVHG
IRUGLVWULEXWLRQ

$GHYLFHGHILFLHQF\''LVGHILQHGDVDQLQDGHTXDF\RIDPHGLFDOGHYLFHZLWKUHVSHFWWRLWVLGHQWLW\TXDOLW\
GXUDELOLW\UHOLDELOLW\VDIHW\RUSHUIRUPDQFH


,IWKHFRPSODLQW''GRHVQRWLQYROYHDQ$(WKHLQYHVWLJDWRUPXVWQRWLI\WKH$EERWW3RVW0DUNHW6XUYHLOODQFH
'HSDUWPHQWE\VXEPLWWLQJWKHFRPSODLQWLQIRUPDWLRQYLDHPDLOWR&&RRUGLQDWRUV#VMPFRPRUE\SKRQH
DVVRRQDVSRVVLEOHDIWHUEHFRPLQJDZDUHRIWKHFRPSODLQW
&RPSODLQWV''VLQIRUPDWLRQZLOOQRWEHFROOHFWHGRQD&5)IRUWKHVWXG\

,I WKH FRPSODLQW'' LQYROYHV DQ $( WKH LQYHVWLJDWRU PXVW FRPSOHWH DQ $( WKURXJK WKH ('& V\VWHP
LQFOXGLQJWKHLQIRUPDWLRQRQWKHFRPSODLQWDQGVXEPLWWR$EERWWDVVRRQDVSRVVLEOH

6RXUFHUHFRUGV
6RXUFHGRFXPHQWVZLOOEHFUHDWHGDQGPDLQWDLQHGE\WKHLQYHVWLJDWLRQDOVLWHWHDPWKURXJKRXWWKHFOLQLFDO
LQYHVWLJDWLRQ7KHGDWDUHSRUWHGRQWKH&5)VZLOOEHGHULYHGIURPDQGEHFRQVLVWHQWZLWKWKHVHVRXUFH
GRFXPHQWVDQGDQ\GLVFUHSDQFLHVZLOOEHH[SODLQHGLQZULWLQJ

5HFRUGV5HWHQWLRQ
7KH6SRQVRUDQGWKH3ULQFLSDO,QYHVWLJDWRUVZLOOPDLQWDLQWKHFOLQLFDOLQYHVWLJDWLRQGRFXPHQWVDVUHTXLUHG
0HDVXUHVZLOOEHWDNHQWRSUHYHQWDFFLGHQWDORUSUHPDWXUHGHVWUXFWLRQRIWKHVHGRFXPHQWV7KH3ULQFLSDO
,QYHVWLJDWRURUWKH6SRQVRUPD\WUDQVIHUFXVWRG\RIUHFRUGVWRDQRWKHUSHUVRQSDUW\DQGGRFXPHQWWKH
WUDQVIHUDWWKHLQYHVWLJDWLRQDOVLWHRUWKH6SRQVRU¶VIDFLOLW\DVDSSURSULDWH

7KHVHGRFXPHQWVPXVWEHUHWDLQHGE\WKHLQYHVWLJDWLRQDOVLWHIRUDSHULRGRI\HDUVDIWHUWKHFRQFOXVLRQ
RIWKHFOLQLFDOLQYHVWLJDWLRQDQGPDGHDYDLODEOHIRUPRQLWRULQJRUDXGLWLQJE\WKH6SRQVRU¶VUHSUHVHQWDWLYH
RUUHSUHVHQWDWLYHVRIWKHDSSOLFDEOHUHJXODWRU\DJHQFLHV

$OORULJLQDOVRXUFHGRFXPHQWVPXVWEHVWRUHGIRUWKHPD[LPXPWLPHUHTXLUHGE\WKHUHJXODWLRQVDWWKH
KRVSLWDO UHVHDUFK LQVWLWXWH RU SUDFWLFH LQ TXHVWLRQ ,I RULJLQDO VRXUFH GRFXPHQWV FDQ QR ORQJHU EH
PDLQWDLQHGDWWKHVLWHWKHLQYHVWLJDWRUZLOOQRWLI\WKH6SRQVRU

&OLQLFDO'DWD+DQGOLQJ
7KH6SRQVRUZLOOEHUHVSRQVLEOHIRUWKHGDWDKDQGOLQJ7KH6SRQVRUDQGRULWVDIILOLDWHVZLOOEHUHVSRQVLEOH
IRUFRPSLOLQJDQGVXEPLWWLQJDOOUHTXLUHGUHSRUWVWRJRYHUQPHQWDODJHQFLHV'DWDZLOOEHDQDO\]HGE\WKH
6SRQVRU DQG PD\ EH WUDQVIHUUHG WR WKH 6SRQVRU¶V ORFDWLRQV ZRUOGZLGH DQGRU DQ\ RWKHU ZRUOGZLGH
UHJXODWRU\DXWKRULW\LQVXSSRUWRIDPDUNHWDSSURYDODSSOLFDWLRQ


6WXG\'RFXPHQW1R6-0&,39HU>&@
6WXG\1DPH'(/,9(5<
&OLQLFDO,QYHVWLJDWLRQ 3ODQ

7KLVFRQILGHQWLDOGRFXPHQWLVWKHSURSHUW\RI$EERWWDQGVKDOOQRWEHUHSURGXFHGGLVWULEXWHGGLVFORVHGRUXVHGZLWKRXWWKH
H[SUHVVZULWWHQFRQVHQWRI$EERWW
B&,37HPSODWHB5HYB&
3DJHRI
>5('$&7('@



3URWHFWLRQRI3HUVRQDOO\,GHQWLILDEOH,QIRUPDWLRQ
$EERWW UHVSHFWV DQG SURWHFWV SHUVRQDOO\ LGHQWLILDEOH LQIRUPDWLRQ FROOHFWHG RU PDLQWDLQHG IRU WKLV FOLQLFDO
LQYHVWLJDWLRQ7KHSULYDF\RIHDFKVXEMHFWDQGFRQILGHQWLDOLW\RIKLVKHULQIRUPDWLRQZLOOEHSUHVHUYHGLQ
UHSRUWVDQGZKHQSXEOLVKLQJDQ\GDWD&RQILGHQWLDOLW\RIGDWDZLOOEHREVHUYHGE\DOOSDUWLHVLQYROYHGDWDOO
WLPHVWKURXJKRXWWKHFOLQLFDOLQYHVWLJDWLRQ$OOGDWDZLOOEHVHFXUHGDJDLQVWXQDXWKRUL]HGDFFHVV

'DWD0DQDJHPHQW3ODQ
$'DWD0DQDJHPHQW3ODQ'03ZLOOGHVFULEHSURFHGXUHVXVHGIRUGDWDUHYLHZGDWDEDVHFOHDQLQJDQG
LVVXLQJ DQG UHVROYLQJ GDWD TXHULHV ,I DSSURSULDWH WKH '03 PD\ EH XSGDWHG WKURXJKRXW WKH FOLQLFDO
LQYHVWLJDWLRQGXUDWLRQ$OOUHYLVLRQVZLOOEHWUDFNHGDQGGRFXPHQWFRQWUROOHG

6XEMHFWGDWDZLOOEHFDSWXUHGLQDYDOLGDWHGHOHFWURQLFGDWDFDSWXUH('&V\VWHPKRVWHGE\WKH6SRQVRU

2QO\DXWKRUL]HGVLWHSHUVRQQHOZLOOEHSHUPLWWHGWRHQWHUWKH&5)GDWDWKURXJKWKH('&V\VWHPGHSOR\HG
E\$EERWW$QHOHFWURQLFDXGLWWUDLOZLOOEHXVHGWRWUDFNDQ\VXEVHTXHQWFKDQJHVRIWKHHQWHUHGGDWD

'RFXPHQWDQG'DWD&RQWURO

7UDFHDELOLW\RI'RFXPHQWVDQG'DWD
7KHLQYHVWLJDWRUZLOOHQVXUHDFFXUDF\FRPSOHWHQHVVOHJLELOLW\DQGWLPHOLQHVVRIWKHGDWDUHSRUWHGWRWKH
6SRQVRURQWKH&5)VDQGLQDOOUHTXLUHGUHSRUWV

5HFRUGLQJ'DWD
7KH&5)ZLOOEHUHYLHZHGE\WKHDXWKRUL]HGVLWHSHUVRQQHO$QDSSURSULDWHFRPPHQWZLOOEHSURYLGHGWR
H[SODLQFKDQJHVWRGDWDUHSRUWHGRQWKH&5)
 0RQLWRULQJ
,WLVWKHUHVSRQVLELOLW\RIWKH6SRQVRUWRHQVXUHWKHFOLQLFDOLQYHVWLJDWLRQLVFRQGXFWHGUHFRUGHGDQGUHSRUWHG
DFFRUGLQJ WR WKH DSSURYHG &,3 VXEVHTXHQW DPHQGPHQWV DSSOLFDEOH UHJXODWLRQV DQG JXLGDQFH
GRFXPHQWV

0RQLWRULQJZLOOEHFRQGXFWHGDFFRUGLQJWR$EERWW¶V&OLQLFDO0RQLWRULQJZRUNLQVWUXFWLRQ
3ULRUWREHJLQQLQJWKHFOLQLFDOLQYHVWLJDWLRQWKH6SRQVRUZLOOFRQWDFWWKHLQYHVWLJDWRURUGHVLJQHHWRGLVFXVV
WKHFOLQLFDOLQYHVWLJDWLRQDQGGDWDUHTXLUHPHQWV$GHVLJQDWHGPRQLWRUZLOOSHULRGLFDOO\UHYLHZWKHVXEMHFW
UHFRUGVDQGDVVRFLDWHGVRXUFHGRFXPHQWV7KHLQYHVWLJDWRUVKDOOPDNHVXEMHFWDQGFOLQLFDOLQYHVWLJDWLRQ
UHFRUGVDYDLODEOHWRWKHFOLQLFDOPRQLWRUIRUPRQLWRULQJ

&HQWUDOL]HGPRQLWRULQJZLOORFFXUWKURXJKURXWLQHLQWHUQDOGDWDUHYLHZ7KLVPRQLWRULQJLVGHVLJQHGWRLGHQWLI\
PLVVLQJDQGLQFRQVLVWHQWGDWDGDWDRXWOLHUVDQGSRWHQWLDO&,3GHYLDWLRQVWKDWPD\EHLQGLFDWLYHRIVLWHQRQ
FRPSOLDQFH2QVLWHPRQLWRULQJPD\RFFXUDWWKHGLVFUHWLRQRIWKH6SRQVRU
 &RPSOLDQFH6WDWHPHQW
 6WDWHPHQWRI&RPSOLDQFH
7KLVFOLQLFDOLQYHVWLJDWLRQZLOOEHFRQGXFWHGLQFRPSOLDQFHZLWKWKHPRVWFXUUHQWUHJLRQDODQGORFDOODZVDQG
UHJXODWLRQV3ULQFLSOHVRI*RRG&OLQLFDO3UDFWLFHZLOOEHIROORZHGDVEDVHGRQWKHPRVWFXUUHQWYHUVLRQRI
WKH:RUOG0HGLFDO$VVRFLDWLRQ:0$'HFODUDWLRQRI+HOVLQNL



6WXG\'RFXPHQW1R6-0&,39HU>&@
6WXG\1DPH'(/,9(5<
&OLQLFDO,QYHVWLJDWLRQ 3ODQ

7KLVFRQILGHQWLDOGRFXPHQWLVWKHSURSHUW\RI$EERWWDQGVKDOOQRWEHUHSURGXFHGGLVWULEXWHGGLVFORVHGRUXVHGZLWKRXWWKH
H[SUHVVZULWWHQFRQVHQWRI$EERWW
B&,37HPSODWHB5HYB&
3DJHRI
>5('$&7('@


7KHLQYHVWLJDWRUZLOOVLJQD&OLQLFDO7ULDO$JUHHPHQWDQGDJUHHVWREHFRPSOLDQWZLWKLW7KHLQYHVWLJDWRUZLOO
QRW VWDUW HQUROOLQJ SDWLHQWV RU UHTXHVWLQJ LQIRUPHG FRQVHQW IURP DQ\ SDWLHQW SULRU WR REWDLQLQJ ,5%(&
DSSURYDODQGUHOHYDQW5HJXODWRU\$XWKRULW\DSSURYDOLIDSSOLFDEOHDQGDXWKRUL]DWLRQIURPWKH6SRQVRULQ
ZULWLQJ IRU WKH FOLQLFDO LQYHVWLJDWLRQ ,I DGGLWLRQDO UHTXLUHPHQWV DUH LPSRVHG E\ WKH ,5%(& RU UHOHYDQW
5HJXODWRU\$XWKRULW\WKRVHUHTXLUHPHQWVZLOOEHIROORZHG,IDQ\DFWLRQLVWDNHQE\DQ,5%(&RUDUHOHYDQW
5HJXODWRU\ $XWKRULW\ ZLWK UHVSHFW WR WKH FOLQLFDO LQYHVWLJDWLRQ WKDW LQIRUPDWLRQ ZLOO EH IRUZDUGHG WR WKH
6SRQVRU

$VWKH6SRQVRU$EERWWKDVWDNHQXSJHQHUDOOLDELOLW\LQVXUDQFHLQDFFRUGDQFHZLWKWKHUHTXLUHPHQWVRIWKH
DSSOLFDEOH ORFDO ODZV $Q DSSURSULDWH $EERWW FRXQWU\ UHSUHVHQWDWLYH ZLOO EH XWLOL]HG WR XQGHUVWDQG WKH
UHTXLUHPHQWV IRU WKH W\SH RI LQVXUDQFH WKDW ZLOO EH SURYLGHG IRU VXEMHFWV DQG VXFK LQIRUPDWLRQ ZLOO EH
LQFRUSRUDWHGLQWRWKHVLWHLQIRUPHGFRQVHQWDVDSSOLFDEOH,IUHTXLUHGDGGLWLRQDOVXEMHFWFRYHUDJHRUD
FOLQLFDOLQYHVWLJDWLRQVSHFLILFLQVXUDQFHZLOOEHSURYLGHGE\WKH6SRQVRU
 4XDOLW\$VVXUDQFH$XGLWVDQG5HJXODWRU\,QVSHFWLRQV
7KHLQYHVWLJDWRUDQGRUGHOHJDWHVKRXOGFRQWDFWWKH6SRQVRULPPHGLDWHO\XSRQQRWLILFDWLRQRIDUHJXODWRU\
DXWKRULW\ LQVSHFWLRQ DW WKH VLWH $ PRQLWRU RU GHVLJQHH ZLOO DVVLVW WKH LQYHVWLJDWRU DQGRU GHOHJDWH LQ
SUHSDULQJIRUWKHDXGLW7KH6SRQVRUPD\SHUIRUPTXDOLW\DVVXUDQFHDXGLWVDVUHTXLUHG

7KH3ULQFLSDO,QYHVWLJDWRURULQVWLWXWLRQZLOOSURYLGHGLUHFWDFFHVVWRVRXUFHGDWDGXULQJDQGDIWHUWKHFOLQLFDO
LQYHVWLJDWLRQIRUPRQLWRULQJDXGLWV,5%(&UHYLHZDQGUHJXODWRU\DXWKRULW\LQVSHFWLRQVDVUHTXLUHG7KH
3ULQFLSDO,QYHVWLJDWRURULQVWLWXWLRQZLOOREWDLQSHUPLVVLRQIRUGLUHFWDFFHVVWRVRXUFHGRFXPHQWVIURPWKH
VXEMHFWKRVSLWDODGPLQLVWUDWLRQDQGQDWLRQDOUHJXODWRU\DXWKRULWLHVEHIRUHVWDUWLQJWKHFOLQLFDOLQYHVWLJDWLRQ
 5HSHDWHGDQG6HULRXV1RQ&RPSOLDQFH
,QWKHHYHQWRIUHSHDWHG QRQFRPSOLDQFHRUDRQHWLPHVHULRXVQRQFRPSOLDQFHDVGHWHUPLQHGE\WKH
6SRQVRUDPRQLWRURUGHVLJQHHZLOODWWHPSWWRVHFXUHFRPSOLDQFHE\RQHRUPRUHRIWKHIROORZLQJDFWLRQV
x
9LVLWLQJWKHLQYHVWLJDWRU
x
&RQWDFWLQJWKHLQYHVWLJDWRUE\WHOHSKRQH
x
&RQWDFWLQJWKHLQYHVWLJDWRULQZULWLQJ
x
5HWUDLQLQJRIWKHLQYHVWLJDWRU

,IDQLQYHVWLJDWRULVIRXQGWREHUHSHDWHGO\QRQFRPSOLDQWZLWKWKHVLJQHGDJUHHPHQWWKH&,3RUDQ\RWKHU
FRQGLWLRQVRIWKHFOLQLFDOLQYHVWLJDWLRQWKH6SRQVRUZLOOHLWKHUVHFXUHFRPSOLDQFHRUDWLWVVROHGLVFUHWLRQ
WHUPLQDWHWKHLQYHVWLJDWRU¶VSDUWLFLSDWLRQLQWKHFOLQLFDOLQYHVWLJDWLRQ,QFDVHRIWHUPLQDWLRQWKH6SRQVRUZLOO
LQIRUPWKHUHVSRQVLEOHUHJXODWRU\DXWKRULW\DVUHTXLUHGDQGHQVXUHWKDWWKH,5%(&LVQRWLILHGHLWKHUE\
WKH3ULQFLSDO,QYHVWLJDWRURUE\WKH6SRQVRU
 6XVSHQVLRQRU3UHPDWXUH7HUPLQDWLRQRIWKH&OLQLFDO,QYHVWLJDWLRQ
7KH6SRQVRUUHVHUYHVWKHULJKWWRWHUPLQDWHWKHFOLQLFDOLQYHVWLJDWLRQDWDQ\VWDJHZLWKDSSURSULDWHZULWWHQ
QRWLFHWRWKHLQYHVWLJDWRUV,5%(&VDQGUHOHYDQW5HJXODWRU\DXWKRULWLHVLIUHTXLUHG
$3ULQFLSDO,QYHVWLJDWRU,5%(&RUUHJXODWRU\DXWKRULW\PD\VXVSHQGRUSUHPDWXUHO\WHUPLQDWHSDUWLFLSDWLRQ
LQDFOLQLFDOLQYHVWLJDWLRQDWWKHLQYHVWLJDWLRQDOVLWHVIRUZKLFKWKH\DUHUHVSRQVLEOH7KHLQYHVWLJDWRUVZLOO
IROORZWKHUHTXLUHPHQWVVSHFLILHGLQWKH&OLQLFDO7ULDO$JUHHPHQW

,IVXVSLFLRQRIDQXQDFFHSWDEOHULVNWRVXEMHFWVDULVHVGXULQJWKHFOLQLFDOLQYHVWLJDWLRQRUZKHQVRLQVWUXFWHG
E\WKH,5%(&RUUHJXODWRU\DXWKRULW\WKH6SRQVRUPD\VXVSHQGWKHFOLQLFDOLQYHVWLJDWLRQZKLOHWKHULVNLV
DVVHVVHG7KH6SRQVRUZLOOWHUPLQDWHWKHFOLQLFDOLQYHVWLJDWLRQLIDQXQDFFHSWDEOHULVNLVFRQILUPHG,IWKH
6SRQVRUFRPSOHWHVDQDQDO\VLVRIWKHUHDVRQVIRUWKHVXVSHQVLRQLPSOHPHQWVWKHQHFHVVDU\FRUUHFWLYH
DFWLRQVDQGGHFLGHVWROLIWWKHWHPSRUDU\VXVSHQVLRQWKH6SRQVRUZLOOLQIRUPWKH3ULQFLSDO,QYHVWLJDWRUV

 
Study Document No: SJM-CIP-10116 Ver. [C] 
Study Name: DELIVERY 
 
Clinical Investigation Plan 
 
This confidential document is the property of Abbott and shall not be reproduced, distributed, disclosed or used without the 
express written consent of Abbott. 
86357_CIP Template_Rev_C 
Page 32 of 39 
                                             [REDACTED] 
 
 
IRB/EC, or regulatory authority, where appropriate, of the rationale, providing them with the relevant data 
supporting this decision. Approval from the IRB/EC or regulatory authority, where appropriate, will be 
obtained before the clinical investigation resumes. If subjects have been informed of the suspension, the 
Principal Investigator or authorized designee will inform them of the reasons for resumption. 
 
If the Sponsor suspends or prematurely terminates the clinical investigation at an individual investigational 
site in the interest of safety, the Sponsor will inform all other Principal Investigators. 
 
If suspension or premature termination occurs, the Sponsor will remain responsible for providing resources 
to fulfill the obligations from the CIP and existing agreements for following up the subjects enrolled in the 
clinical investigation, and the Principal Investigator or authorized designee will promptly inform the enrolled 
subjects at his/her investigational site, if appropriate. 
13 Clinical Investigation Conclusion 
The clinical investigation will be concluded when: 
• 
All sites are closed AND 
• 
The final report has been provided to investigators or the Sponsor has provided formal 
documentation of clinical investigation closure. 
14 Publication Policy 
Publications or presentations of clinical investigation methods or results will adhere to Abbott’s publication 
policy, which is based on Good Publication Practices and International Committee of Medical Journal 
Editors (ICMJE) guidelines. A copy of the policy will be provided upon request of the investigator. 
Publication planning and authorship determinations will be overseen by the Steering Committee or 
Publications Committee, and investigators will be notified via email about the dissemination of study data 
and opportunities for involvement as authors on publications/presentations.  
15 Reporting Results on ClincalTrials.gov Website  
This clinical investigation will be registered on ClinicalTrials.gov. A full report of the pre-specified 
outcomes, regardless of the results, will be made public through the ClinicalTrials.gov website.  
 
 
 
 

 
Study Document No: SJM-CIP-10116 Ver. [C] 
Study Name: DELIVERY 
 
Clinical Investigation Plan 
 
This confidential document is the property of Abbott and shall not be reproduced, distributed, disclosed or used without the 
express written consent of Abbott. 
86357_CIP Template_Rev_C 
Page 33 of 39 
                                             [REDACTED] 
 
 
16 Appendix A: CIP Revisions 
 
Procedure for CIP Amendments 
 
This CIP may be amended as appropriate by the Sponsor. Rationale will be included with each amended 
version in the revision history table below. The version number and date of amendments will be 
documented. 
 
The acknowledgement of the amended CIP by the Principal Investigators will be collected on the 
signature pages. 
 
IRB/EC and relevant Regulatory Authorities, if applicable, will be notified of amendments to the CIP. 
 
Revision History 
Amendment 
Number 
Version 
Date 
Rationale 
Details 
Not 
Applicable 
VB 
12JUN2016 
First release of 
CIP 
NA 
1 
VC 
21JUN2017 
Amendment 
Substantial Amendment 
 
 
 

 
Study Document No: SJM-CIP-10116 Ver. [C] 
Study Name: DELIVERY 
 
Clinical Investigation Plan 
 
This confidential document is the property of Abbott and shall not be reproduced, distributed, disclosed or used without the 
express written consent of Abbott. 
86357_CIP Template_Rev_C 
Page 34 of 39 
                                             [REDACTED] 
 
 
17 Appendix B: Definitions 
 
Non-study Specific Definitions 
 
Adverse Event (AE) 
Any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including 
abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical 
device under clinical investigation. 
 
This definition includes events related to the medical device or the comparator. 
This definition includes events related to the procedures involved. 
 
Serious Adverse Event (SAE) 
An adverse event that led to: 
• 
Death 
• 
A serious deterioration in the health of the subject, that either resulted in: 
o 
A life-threatening illness or injury OR 
o 
A permanent impairment to a body structure or a body function OR 
o 
An in-patient or prolonged hospitalization OR 
o 
A medical or surgical intervention to prevent life-threatening illness or injury or permanent 
impairment to a body structure or a body function OR 
o 
A malignant tumor (only for specific countries) 
• 
Fetal distress, fetal death or a congenital abnormality or birth defect 
 
A planned hospitalization for a pre-existing condition, or a procedure required by the CIP is not considered 
a serious adverse event. 
 
Adverse Device Effect (ADE) 
An adverse event related to the use of a medical device. 
 
This definition includes adverse events resulting from insufficient or inadequate instructions for use, 
deployment, implantation, installation, or operation, or any malfunction of the medical device. 
 
This definition includes any event resulting from the use error or from intentional misuse of the medical 
device. 
 
Serious Adverse Device Effect (SADE) 
Adverse device effect that has resulted in any of the consequences characteristic of a serious adverse 
event. 
 
 
 
 

 
Study Document No: SJM-CIP-10116 Ver. [C] 
Study Name: DELIVERY 
 
Clinical Investigation Plan 
 
This confidential document is the property of Abbott and shall not be reproduced, distributed, disclosed or used without the 
express written consent of Abbott. 
86357_CIP Template_Rev_C 
Page 35 of 39 
                                             [REDACTED] 
 
 
18 Appendix C: BurstDR Programming Guidelines 
 
BurstDR Programming: 
 
1. Prior to programming: 
• 
Limit distractions by using a quiet location. 
• 
Have the subject lie on their back. 
• 
Explain to the subject that a sensation is any sort of change felt, such as warmth, 
heaviness, pressure, tingling, etc. 
 
2. Establish paresthesia coverage using standard tonic stimulation. 
• 
It is advised to find coverage in a single stimset (area) with a simple array. 
• 
This can lead to reduced amplitude requirements. 
Note:  The intent is to confirm coverage of entire/all pain areas, which may require higher 
than comfortable stimulation levels in certain spots. 
 
3. If multiple stimsets were required to fully cover the subject’s pain, combine all areas into a single 
stimset (area). To combine areas, copy all cathodes (negative) and then fill anodes (positive) 
into remaining contacts that were utilized across tonic stimulation stimsets. 
 
Note: Test combined configuration with tonic to ensure combination of stimsets resulted in no 
unexpected coverage changes. 
 
4. Enable Burst mode. 
Do not change the burst-rate (40 Hz), intraburst-rate (500 Hz) and PW (1000 µs). 
 
5. Slowly ramp amplitude upwards by 0.05 mA until subject experiences any sensation (pressure, 
heat, etc.). 
 
6. Slowly decrease amplitude until sensation disappears. 
 
7. Note the amplitude value and confirm value by repeating steps 5 and 6. 
 
8. Reduce amplitude by 40%. Set this as your Target Amplitude. 
 
9. Adjust the Maximum Amplitude for the Patient Controller settings to the lowest possible value that 
is still above your Target. 
 
10. At this point, consider whether cycling can be used to improve longevity. Start with 5 seconds on 
15 seconds off. If further optimization is needed, change to 5 seconds on 5 seconds off. 
 
Note: If the subject feels the need to adjust therapy after the initial programming, advise them to 
adjust their amplitude by one click and allow time to assess the change before making additional 
adjustments. If multiple adjustments are needed, schedule the subject for a reprogramming 
session to determine new, ideal amplitude settings. 
 
 
 

 
Study Document No: SJM-CIP-10116 Ver. [C] 
Study Name: DELIVERY 
 
Clinical Investigation Plan 
 
This confidential document is the property of Abbott and shall not be reproduced, distributed, disclosed or used without the 
express written consent of Abbott. 
86357_CIP Template_Rev_C 
Page 36 of 39 
                                             [REDACTED] 
 
 
19 Appendix D: Imaging Guidelines 
 
At time of trial implant:  
At the end of the intraoperative lead placement procedure, including anchoring procedure, a “at time of trial 
implant image” will be saved with the fluoroscope. The investigator should align the vertebral endplates (in 
an AP view) and be certain to include the thoracic/lumbar junction in the image, such that the vertebral level 
of the lead is easily countable/verifiable. A lateral image should also be saved. The images should be 
printed out and saved with the CRF. If the images cannot be printed directly, they may be screen shot with 
an iPad (or equivalent) and printed later. The level of the lead tip and proximal contact will be noted on the 
Case Report Form (CRF).  
End of trial evaluation period: 
At the End of Initial Trial Evaluation Period study visit and the End of Extended Trial Evaluation Period study 
visit (if applicable), the patient should have another fluoroscopic image taken as above. The image should 
be printed out as above. The image level and patient position (standing vs. sitting) should be noted by the 
investigator and recorded on the CRF. 
 
Alternate acceptable end of trial evaluation period radiograph procedure for clinics without a 
fluoroscope in/near clinic (US):  At the end of the initial trial evaluation period study visit and the 
extended evaluation period study visit (if applicable), the patient will have a thoraco-lumbar AP/LAT set 
of spinal plain radiographs done at an imaging facility and printed onto a DVD. That DVD will be viewed 
and read by the investigator, recording the end of trial evaluation period lead location on the CRF. The 
DVD will be kept with the subjects research file. 
 
Alternate acceptable end of trial evaluation period radiograph procedure for clinics without a 
fluoroscope in/near clinic (OUS):  At the end of the initial trial evaluation period study visit or the 
extended evaluation period study visit (if applicable), the patient will have a thoraco-lumbar AP/LAT 
set of spinal plain radiographs done at an imaging facility and printed onto a DVD or provided in pdf 
form for upload. If an imaging facility is not available, the radiographs can be taken on the OR/suite x-
ray machine provided that a printout can be collected for upload. That DVD/PDF will be viewed and 
read by the investigator , recording the end of trial evaluation period lead location on the CRF. The 
DVD/PDF will be kept with the subjects research file. 
 
 
 

 
Study Document No: SJM-CIP-10116 Ver. [C] 
Study Name: DELIVERY 
 
Clinical Investigation Plan 
 
This confidential document is the property of Abbott and shall not be reproduced, distributed, disclosed or used without the 
express written consent of Abbott. 
86357_CIP Template_Rev_C 
Page 37 of 39 
                                             [REDACTED] 
 
 
20 Appendix E: Bibliography 
 
1. Taylor RS. Spinal cord stimulation in complex regional pain syndrome and refractory neuropathic back 
and leg pain/failed back surgery syndrome: Results of a systematic review and meta-analysis. J Pain 
Symp Mgmt, 2006; 31(4S):S13-S19. 
 
2. Deyo RA, Dworkin SF, Amtmann D, Andersson G, Borenstein D, Carragee E, Carrino J, Chou R, Cook 
K, DeLitto A, Goertz C, Khalsa P, Loeser J, Mackey S, Panagis J, Rainville J, Tosteson T, Turk D, Von 
Korff M, Weiner DK. Report of the NIH Task Force on research standards for chronic low back pain. J 
Pain. 2014 Jun;15(6):569-85. 
 
3. Huang KT, et.al. A national survey of spinal cord stimulation trial-to-permanent conversion rates. 
Neuromodulation, 2014; Neuromodulation, 2015;18(2):133-9. 
 
4. Deyo RA, Ramsay K, Buckley DI, Michales L, Kobus A, Eckstorm E, Forro V, Morris C. Performance 
of a patient reported outcomes measurement information system (promis) short form in older adults 
with chronic musculoskeletal pain. Pain Medicine 2016; 17: 314–324. 
 
5. Rosenberg J, et. al. Spinal cord stimulation provides pain relief with improved psychosocial function: 
results from EMP3OWER. Pain Medicine, 2016; 17: 2311–2325. 
 
 
 
 
 
 
 
 

 
Study Document No: SJM-CIP-10116 Ver. [C] 
Study Name: DELIVERY 
 
Clinical Investigation Plan 
 
This confidential document is the property of Abbott and shall not be reproduced, distributed, disclosed or used without the 
express written consent of Abbott. 
86357_CIP Template_Rev_C 
Page 38 of 39 
                                             [REDACTED] 
 
 
21 Appendix F: Case Report Form 
A sample Case Report Form will be kept under a separate cover and is available upon request. 
 
 
 

 
Study Document No: SJM-CIP-10116 Ver. [C] 
Study Name: DELIVERY 
 
Clinical Investigation Plan 
 
This confidential document is the property of Abbott and shall not be reproduced, distributed, disclosed or used without the 
express written consent of Abbott. 
86357_CIP Template_Rev_C 
Page 39 of 39 
                                             [REDACTED] 
 
 
22 Appendix G: Informed Consent Form 
A sample Informed Consent will be kept under a separate cover and is available upon request.