Clinical trial NCT04085367
Conditions: Actinic Keratoses
Sponsor: Galderma R&D
Start date: 2019-09-30; Completion date: 2021-04-07
Enrollment: 557 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A Randomized, Double-Blind, Vehicle-Controlled, Multicenter Study to Assess the Efficacy and Safety of Methyl aminolevulinate hydrochloride (MAL) 16.8% cream (CD06809-41) versus vehicle cream in the treatment of thin and moderately thick, non-hyperkeratotic, non-pigmented actinic keratosis of the face and scalp when using daylight photodynamic therapy (DL-PDT).

Detailed description:
This was a randomized, double-blind, vehicle-controlled, multicenter, parallel-group study in adult participants with clinically-confirmed mild to moderate AKs on the face and the balding scalp, to be conducted at approximately 60 clinical sites in the United States. Sites were selected to ensure that diverse daylight conditions represented in the study to understand the effects of latitude, elevation, and climate.

Arms: arm 1: Participants received two treatment session at least 2 weeks apart. Investigator applied a thin layer of methyl aminolevulinate (MAL) hydrochloride 16.8% cream to each lesion during treatment. At 30 minutes after cream application, participants went outside in daylight for 2 hours (Daylight photodynamic therapy \[DL-PDT\]). After this time, the cream was removed by investigative site personnel by washing the skin with gentle skin cleanser. arm 2: Participants received two treatment session at least 2 weeks apart. Investigator applied a thin layer of vehicle cream to each lesion during treatment. At 30 minutes after cream application, participants went outside in daylight for 2 hours (DL-PDT). After this time, the cream was removed by investigative site personnel by washing the skin with gentle skin cleanser.
Interventions: intervention 1: MAL 16.8% cream intervention 2: MAL Vehicle Cream
Intervention descriptions: intervention 1: Day light photodynamic therapy with MAL 16.8% cream intervention 2: Day light photodynamic therapy with MAL vehicle cream

Protocol documents:
Prot_000.pdf: 
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SAP_001.pdf: 
 
R D. 0 6. S P R. 1 1 2 1 9 9  
 
 
Pa ge 1 of 4 3  
St atistic al A n al ysis Pl a n  
 
 
 
 
A  R a n d o mize d,  D o u ble -Bli n d,  Ve hicle -C o ntr olle d,  M ultice nter  St u d y  t o  Assess  t h e  Effic ac y  a n d  S afet y  of 
Met h yl  a mi n ole v uli n ate  h y dr oc hl ori de  ( M A L)  1 6. 8 %  cre a m  ( C D 0 6 8 0 9 -4 1)  vers us  ve hicle  cre a m  i n  t he 
tre at m e nt of t hi n a n d m o der atel y t hic k, n o n-h y per k er at otic, n o n -pi g m e nte d acti nic k er at osis of t he f ace a n d 
sc al p w he n usi n g d a yli g ht p h ot o d y n a mic t her a p y ( D L-P D T)  
 
S T A TI S TI C A L A N A L Y SI S P L A N  
 
R D. 0 6. S P R. 1 1 2 1 9 9  
 
Versi o n Fi n al 2. 0  
 
0 6 -A P R -2 0 2 1  
 






 
R D. 0 6. S P R. 1 1 2 1 9 9  
 
 
Pa ge 4 of 4 3  
St atistic al A n al ysis Pl a n  
 
 
Versi o n Fi n al 2. 0, 0 6 -A P R- 2 0 2 1  
Draft versi o n 1. 2  
0 1 -J U L-2 0 2 0  
 
 u p date d  t he  " A nal ysis  Visits  Defi niti o n" 
secti o n, i m ple me nte d  t he  c ha n ges  s u g geste d  b y  
 
 a n d iss ue d t he draft versi o n 1. 2  
Draft versi o n 1. 3  
3 1 -J U L-2 0 2 0  
 
 u p date d t he st u d y sc he ma, secti o ns 2, 4 a n d 
9 of t he  S A P o n t he basis of t he fi nal versi o n 3. 0  of t he st u d y 
pr ot oc ol  a n d fi xe d fe w mi n or err ors i n t he secti o n 1 2  
Draft versi o n 1. 4  
2 4 -M A R -2 0 2 1  
 
 i m ple me nte d t he f oll o wi n g up date s: 
•  
i n  secti o n  8. 2 it  was clarifie d t hat  n o n-ra n d o mize d 
s u bjects w h o recei ve d at least o ne a p plicati o n of st u d y 
dr u g b y mista ke will  be liste d se paratel y.  
•  
i n  secti o n  1 0. 1. 6 it  was clarifie d t hat  all  pr o p orti o ns 
will be prese nte d as perce nta ges  
•  
i n secti o n 1 0. 2. 3 a s u m mar y f or Fitz patric k s ki n t y pe 
gr o u p s was a d de d  
•  
i n  secti o n  1 0. 6. 1  it  was  clarifie d  t hat  co nfi de nce 
i nter vals  of  t he  differe nce i n  pr o p orti o ns wit hi n  
a nal ysis  ce nters  will  be 
calc ulate d  usi n g  t he 
Ne wc o m be  met h o d  wit h o ut  a  c o nti n uit y  c orrecti o n, 
base d  o n  t he  t w o  i n di vi d ual  Wils o n  c o nfi de nce 
i nter vals 
•  
i n secti o n 1 0. 6. 2. 2 a se nsiti vit y a nal ysis to  assess  t he 
i m pact of s u bjects of Site  
 o n t he pri mar y efficac y 
res ults was a d de d  
•  
i n secti o n 1 0. 6. 4. 2 t he u p per t hres h ol d of 1 2 f or lesi o ns 
i m p utati o n was a d de d 
•  
i n  secti o n  1 0. 6. 4. 2 it  was clarifie d t hat  f or  L O C F 
i m p utati o n baseli ne val ue will be carrie d f or war d if n o 
p ost -baseli ne val ue is a vaila ble  
•  
i n  secti o n 1 0. 7. 3  t he  t hres h ol d f or  selecti ng c o m m o n 
T E A E i n t he safet y  p o p ulati o n  a n d  s u b gr o u ps was 
c ha n ge d fr o m 5 % t o 1 % ; a ta ble base d o n t he ori gi nal 
5 %  t hres h ol d  w ill  be  prese nte d f or  safet y  p o p ulati o n 
o nl y ( n o s u b gr o u ps s u m maries) 
•  
i n  secti o n 1 0. 7. 6 it  was  a d de d t hat for  s u m mar y 
p ur p oses, la b orat or y val ues t hat are liste d as a b o ve or 
bel o w  partic ular  t hres h ol ds  will  be  n u mericall y 
i m p ute d as a b o ve or bel o w t hat t hres h ol d, res pecti vel y, 
b y t he mi ni m u m meas ure d a m o u nt f or t hat para meter  
•  
i n  secti o n 1 3. 3  criterio n  f or  P C S V  of  Bl o o d  Urea 
Nitr o ge n  was a d de d  a n d s o me err ors were fi xe d  
Fi nal ver si o n 2. 0 
0 6 -A P R -2 0 2 1  
 
 iss ue d t he fi nal versi o n 2 . 0 
P P D
P P D
P P
D
P P D
P P D
P P D
P P D
P P D
P P D
P P D
P P
D


 
R D. 0 6. S P R. 1 1 2 1 9 9  
 
 
Pa ge 5 of 4 3  
St atistic al A n al ysis Pl a n  
 
 
Versi o n Fi n al 2. 0, 0 6 -A P R- 2 0 2 1  
T A B L E O F C O N T E N T S  
 
1  
LI S T O F A B B R E V A TI O N S  
8  
2  
I N T R O D U C TI O N 
9  
3  
S T U D Y O B J E C TI V E S  
9  
3. 1  
Pri m ar y O bjecti ve  
9  
3. 2  
Sec o n d ar y O bjecti ves  
9  
4  
S T U D Y D E SI G N  
9  
5  
E F FI C A C Y A N D S A F E T Y A S S E S S M E N T S  
1 1  
6  
E F FI C A C Y A N D S A F E T Y V A RI A B L E S  
1 4  
6. 1  
Effic ac y V ari a bles  
1 4  
 
Lesi o n Res p o nse  
1 4  
6. 2  
S afet y V ari a bles  
1 4  
 
S u bject Assess m e nt of P ai n  
1 4  
 
S afet y Visit Q uesti o n  
1 5  
 
Cli nic al assess m e nt of t he s u bject’s s ki n as pect  
1 5  
 
A d verse E ve nts  
1 5  
 
Cli nic al L a b or at or y E v al u ati o n  
1 6  
6. 2. 5. 1  
He m at ol o g y  
1 7  
6. 2. 5. 2  
Bl o o d C he mistr y  
1 7  
6. 2. 5. 3  
Uri n al ysis  
1 7  
 
Vit al Si g ns  
1 7  
 
P h ysic al E x a mi n ati o n  
1 7  
 
Electr oc ar di o gr a ms  
1 7  
6. 3  
Ot her V ari a bles  
1 8  
 
S atisf acti o n Q uesti o n n aires  
1 8  
 
We at her Assess m e nt  
1 8  
 
S u bject E x p os ure Ti m e a n d P pI X Effecti ve D ose  
1 8  
 
Pr oce d ures f or S us pecte d Se nsitiz ati o n ( Rec h alle n ge a n d P atc h I n gre die nt Test)  
1 8  
7  
E F FI C A C Y E N D P OI N T S  
2 1  
7. 1  
Pri m ar y E n d p oi nt  
2 1  
7. 2  
Sec o n d ar y E n d p oi nts  
2 1  
8  
P O P U L A TI O N S A N A L Y Z E D  
2 1  
8. 1  
I nte nt-t o-Tre at P o p ul ati o n  
2 1  
8. 2  
S afet y P o p ul ati o n  
2 1  
8. 3  
Per Pr ot oc ol P o p ul ati o n  
2 1  
9  
S A M P L E SI Z E C O N SI D E R A TI O N  
2 2  
1 0  
S T A TI S TI C A L M E T H O D S A N D D A T A C O N SI D E R A TI O N S  
2 2  
1 0. 1  
Ge ner al C o nsi der ati o ns  
2 2  
 
B aseli ne  
2 2  
 
Missi n g D ates M a n a ge m e nt  
2 3  
 
Refere nce St art D ate a n d A n al ysis D a y  
2 3  
 
Descri pti ve St atistics  
2 4  
 
St atistic al Tests a n d C o nfi de nce I nter v als  
2 4  
 
D eci m al Precisi o n  
2 4  
 
S oft w are Versi o n  
2 4  
1 0. 2  
St u d y S u bjects  
2 5  


 
R D. 0 6. S P R. 1 1 2 1 9 9  
 
 
Pa ge 6 of 4 3  
St atistic al A n al ysis Pl a n  
 
 
Versi o n Fi n al 2. 0, 0 6 -A P R- 2 0 2 1  
 
Dis p ositi o n of S u bjects  
2 5  
 
A n al ysis P o p ul ati o n s 
2 5  
 
De m o gr a p hic a n d B aseli ne C h ar acteristics  
2 5  
 
Acc o u nti n g of S u bjects  
2 6  
1 0. 3  
Pr ot oc ol De vi ati o ns  
2 7  
1 0. 4  
Me dic al Hist or y, Pri or a n d C o nc o mit a nt T her a pies a n d Pr oce d ures  
2 7  
1 0. 5  
C o m pli a nce  
2 7  
1 0. 6  
Effic ac y A n al ysis  
2 8  
 
A n al ysis of t he Pri m ar y E n d p oi nt  
2 8  
 
Se nsiti vit y A n al yses of Pri m ar y E n d p oi nt  
2 8  
1 0. 6. 2. 1  
I m p act o n t he Pri m ar y E n d p oi nt of C O VI D-1 9 rel ate d st u d y disr u pti o ns  
2 9  
1 0. 6. 2. 2  
I m p act o n t he Pri m ar y E n dp oi nt of s u bjects of Site 
 
2 9  
 
A n al ysis of Sec o n d ar y E n d p oi nts  
2 9  
 
St atistic al a n d A n al ytic al Iss ues  
3 1  
1 0. 6. 4. 1  
A dj ust m e nt f or C o v ari ates  
3 1  
1 0. 6. 4. 2  
H a n dli n g of Dr o p o uts or Missi n g D at a  
3 1  
1 0. 6. 4. 3  
I nteri m A n al yses a n d D at a M o nit ori n g 
3 2  
1 0. 6. 4. 4  
M ultice nter St u dies  
3 2  
1 0. 6. 4. 5  
M ulti ple C o m p aris o n/ M ulti plicit y  
3 3  
1 0. 6. 4. 6  
Use of a n Effic ac y S u bset of P atie nts  
3 3  
1 0. 6. 4. 7  
Acti ve -C o ntr ol st u dies i nte n de d t o s h o w e q ui v ale nce  
3 3  
1 0. 6. 4. 8  
E x a mi n ati o n of S u b gr o u ps  
3 3  
1 0. 6. 4. 9  
A n al ysis Visits Defi niti o n  
3 4  
1 0. 7  
S afet y A n al ysis  
3 5  
 
S u bject Assess m e nt of P ai n  
3 5  
 
E xte nt of E x p os ure  
3 5  
 
A d verse E ve nts A n al ysis  
3 5  
 
P h ysic al E x a mi n ati o n A n al ysis  
3 7  
 
Vit al Si g ns A n al ysis  
3 7  
 
Cli nic al L a b or at or y Tests A n al ysis  
3 7  
 
Electr oc ar di o gr a ms A n al ysis  
3 8  
 
S afet y Visit Q uesti o n  
3 8  
1 0. 8  
Ot her Assess m e nts A n al ysis  
3 8  
 
S atisf acti o n Q uesti o n n aires A n al ysis  
3 8  
 
We at her Assess m e nt  
3 8  
 
S u bject's S ki n As pect A n al ysis  
3 9  
 
S u bject E x p os ure Ti m e a n d P pI X Effecti ve D ose A n al ysis  
3 9  
 
S us pecte d Se nsitiz ati o n ( Rec h alle n ge a n d P atc h I n gre die nt Test)  
3 9  
1 1  
C H A N G E S F R O M T H E P R O T O C O L A N A L Y SI S P L A N  
3 9  
1 2  
S H E L L S O F T A B L E S, FI G U R E S A N D LI S TI N G S A N D R E P O R TI N G O U T P U T ( G E N E R A L 
F E A T U R E S)  
4 0  
1 3  
A P P E N DI C E S  
4 1  
1 3. 1  
S hells f or T a ble, Fi g ure a n d Listi n gs  
4 1  
1 3. 2  
P ote nti all y Cli nic all y Si g nific a nt V al ues of Vit al Si g ns  
4 1  
1 3. 3  
P ote nti all y Cli nic all y Si g nific a nt V al ues of L a b or at or y Tests  
4 1  
1 4  
R E F E R E N C E S  
4 3  
 
P P
D


 
R D. 0 6. S P R. 1 1 2 1 9 9  
 
 
Pa ge 7 of 4 3  
St atistic al A n al ysis Pl a n  
 
 
Versi o n Fi n al 2. 0, 0 6 -A P R- 2 0 2 1  
T A B L E O F FI G U R E S  
 
Fi g ure 1 - St u d y Sc he m a  
1 1  
 
T A B L E O F T A B L E S  
 
T a ble 1 - Sc he d ule of Assess m e nts  
1 2  
T a ble 2 - Lesi o n Se verit y Gr a de Sc ale  
1 4  
T a ble 3 - Lesi o n Res p o nse S c ore  
1 4  
T a ble 4 - N u m eric al R ati n g Sc ale f or S u bject Self -assess m e nt of P ai n  
1 5  
T a ble 5 - Sc ale f or Cli nic al Assess m e nt of S u bject's S ki n As pect  
1 5  
T a ble 6 - P atc h Test Pr oce d ure  
1 9  
T a ble 7 - S us pecte d Se nsit iz ati o n - C h alle n ge Re acti o n Gr a di n g Sc ale  
1 9  
T a ble 8 - S us pecte d Se nsitiz ati o n - C h alle n ge C o ncl usi o n Sc ale  
2 0  
T a ble 9 - A n al ysis Visits Defi niti o n  
3 4  
T a ble 1 0 - P ote nti all y Cli nic all y Si g nific a nt V al ues of Vit al Si g ns  
4 1  
T a ble 1 1 - P ote nti all y Cli nic all y Si g nific a nt V al ues of L a b or at or y Tests  
4 1  
 


 
R D. 0 6. S P R. 1 1 2 1 9 9  
 
 
Pa ge 8 of 4 3  
St atistic al A n al ysis Pl a n  
 
 
Versi o n Fi n al 2. 0, 0 6 -A P R- 2 0 2 1  
1  
LI S T O F A B B R E V A TI O N S  
A E  
A d verse E ve nt  
A E SI  
A d verse E ve nt of S pecial I nterest  
A K  
Acti nic Kerat osis  
A L A   
5 -a mi n ole v uli nic aci d 
A L T  
Ala ni ne a mi n otra nsferase  
A S T  
As partate a mi n otra nsferase  
CI  
C o nfi de nce i nter val  
C O VI D -1 9  C or o na vir us Disease 2 0 1 9  
C R  
C o m plete Res p o nse  
C R O  
C o ntract Researc h Or ga nizati o n  
C S  
Cli nicall y Si g nifica nt  
C S R  
Cli nical St u d y Re p ort  
D L  
Da yli g ht  
d L  
d eciliter  
E C G  
Electr ocar di o gra m  
e C R F  
Electr o nic Case Re p ort F or m  
E R T  
e Researc h  Tec h n ol o g y, I nc.  
E T  
Earl y Ter mi nati o n  
F S T  
Fitz patric k S ki n T y pe  
G C P  
G o o d Cli nical Practice  
I C 
I nf or me d C o nse nt 
I C F 
I nf or me d c o nse nt f or m 
I C H 
I nter nati o nal C o u ncil f or Har m o nizati o n  of Tec h nical Re q uire me nts f or P har mace uticals f or H u ma n Use  
I R 
Irrita nt Reacti o n 
I R T 
I nteracti ve Res p o nse T ec h n ol o g y 
I T T 
I nte nt-T o -T reat 
L  
liter 
L O C F  
Last O bser vati o n Carrie d F or war d  
M A L  
Met h yl A mi n ole vi n ulate H y dr oc hl ori de  
M A R  
Missi n g A t Ra n d o m 
M C M C  
Mar k o v C hai n M o nte Carl o  
Me d D R A  Me dical Dicti o nar y f or Re g ulat or y Acti vities  
m g  
m illi gra m 
MI  
M ulti ple I m p utati o ns  
m m ol  
m illi m ole 
µ m ol  
m icr o m ole 
M N A R  
Missi n g N ot A t Ra n d o m 
N R S  
N u meric Rati n g S cale 
N T  
N ot Teste d  
O C  
O bser ve d C ase 
P D T  
P h ot o d y na mic T hera p y  
P pI X  
Pr ot o p or p h yri n I X  
P P  
Per P r ot oc ol 
S A E  
Seri o us A d verse E ve nt  
S A F  
Safet y  P o p ulati o n  
S A P  
Statistical A nal ysis P la n 
T E A E  
Treat me nt -e mer ge nt a d verse e ve nt 
U  
u nit  
U L N  
U p per L i mit of N or mal  
W H O  
W orl d Healt h Or ga nizati o n  


 
R D. 0 6. S P R. 1 1 2 1 9 9  
 
 
Pa ge 9 of 4 3  
St atistic al A n al ysis Pl a n  
 
 
Versi o n Fi n al 2. 0, 0 6 -A P R- 2 0 2 1  
2  
I N T R O D U C TI O N 
T his Statistical A nal ysis Pla n ( S A P) is base d o n t he st u d y pr ot oc ol fi nal ve rsi o n 3. 0  date d 1 2 -J U L-2 0 2 0 . T his d oc u me nt 
d escri bes all t he a nal yses a n d re p orti n g t hat will be re q uire d f or a cli nical re p ort p ur p ose a n d a n y res ulti n g p u blicati o ns. 
T his S A P has bee n de vel o pe d pri or t o a n y e xa mi nati o n of st u d y data. T he a nal yses a n d re p orti n g will be perf or me d 
after t he c o m pleti on of st u d y. A n y p ost h oc, or u n pla n ne d, e x pl orat or y a nal yses perf or me d, if i ncl u de d, will be clearl y 
i de ntifie d as s uc h i n t he fi nal Cli nical St u d y Re p ort (C S R ). 
3  
S T U D Y O B J E C TI V E S  
3. 1  
Pri m ar y O bjecti ve  
T he pri mar y o bj ecti ve is t o e val uate t he safet y a n d efficac y of M A L D L -P D T i n a d ult s u bjects wit h mil d t o m o derate 
acti nic kerat oses o n t he face a n d scal p o ver a 1 4 -wee k peri o d, a n d t o s h o w s u peri orit y i n efficac y of M A L crea m o ver 
ve hicle crea m at 1 2 wee ks after t he las t D L-P D T sessi o n ( Visit 6 ). 
3. 2  
Sec o n d ar y  O bjecti ves  
•  
C o m pare t he lesi o n res p o nse bet wee n M A L D L -P D T a n d ve hicle D L -P D T.  
•  
C o m pare partial cleara nce of acti nic kerat oses ( A Ks) bet wee n M A L D L -P D T a n d ve hicle D L -P D T.  
•  
C o m pare s u bject assess me nt of pai n ( b y N R S) bet w ee n M A L D L -P D T a n d ve hicle D L -P D T.  
•  
As sess safet y, i ncl u di n g a d verse e ve nts. 
•  
D oc u me nt t he esti mate d P pI X effecti ve d ose f or eac h s u bject D L -P D T e x p os ure t hr o u g h satellite i ma ge data.  
4  
S T U D Y D E SI G N  
T his is a p hase  3, ra n d o mize d, d o u ble-bli n d, ve hicle -c o ntr olle d, m ultice nter, parallel -gr o u p st u d y  i n a d ult s u bjects wit h 
cli nicall y -c o nfir me d mil d t o m o derate A Ks o n t he face a n d t he bal di n g scal p, t o be c o n d ucte d at a p pr o xi matel y 6 0 
cli nical ce nter s i n t he U nite d States. Cli nical ce nters will be selecte d t o e ns ure t hat di verse da yli g ht c o n diti o ns will be 
re prese nte d i n t he st u d y t o u n dersta n d t he effects of latit u de, ele vati o n, a n d cli mate. 
 
S u bjects will be ra n d o mize d i n a 2: 1 rati o t o recei ve o ne of t he f oll o wi n g t w o treat me nts of da yli g ht p h ot o d y na mic 
t hera p y ( DL- P D T).  
 
Gr o u p 1: C D 0 6 8 0 9 -4 1 Met h yl a mi n ole v uli nate h y dr oc hl ori de  ( M A L) 1 6. 8 % crea m. 
 
Gr o u p 2: V e hicle crea m. 
 
T here will be t w o treat me nt sessi o ns at least 2 wee ks u p t o 4 wee ks a part. T he Pri nci pal I n vesti gat ors will a p pl y a t hi n 
la yer of M A L crea m or ve hicle crea m t o eac h lesi o n d uri n g eac h treat me nt. A t otal of 4 -1 2 lesi o ns will be treate d (t hi n 
la yer o n eac h A K lesi o n a n d s urr o u n di n g 5 t o 1 0 m m of n or mal s ki n ). At 3 0  mi n utes after crea m a p plicati o n, s u bjects 
will g o o utsi de i n da yli g ht f or 2 h o urs. Aft er t his ti me, t he s u bject will ret ur n i nsi de t he i n vesti gati ve ce nter  a n d t he 
crea m will be re m o ve d b y was hi n g t he s ki n wit h ge ntle s ki n clea nser.  
 
T his p hase 3 st u d y is desi g ne d t o e val uate t he safet y a n d efficac y of M A L D L-P D T i n a d ult s u bjects wit h mil d  t o 
m o derate acti nic kerat o sis o n t he face a n d scal p o ver a 1 4-wee k peri o d ( 1 2 wee ks after last  P D T sessi o n) . Male a n d 
fe male s u bjects a ge d ≥ 1 8 years , w h o ha ve at least 4 b ut n o m ore t ha n 1 2 cli nicall y c o nfir me d t hi n a n d m o deratel y 


 
R D. 0 6. S P R. 1 1 2 1 9 9  
 
 
Pa ge 1 0  of 4 3  
St atistic al A n al ysis Pl a n  
 
 
Versi o n Fi n al 2. 0, 0 6 -A P R- 2 0 2 1  
t hic k ( Gra de I a n d II i n t he Olse n scale, res pectivel y), n o n -h y per kerat otic, n o n -pi g me nte d A K lesi o ns l ocate d i n o n t he 
face e xcl u di n g e yeli ds, li ps a n d m uc osa (e. g., f ore hea d, c hee k, c hi n, ), a n d bal di n g scal p will be e nr olle d i n t he st u d y.  
 
T he e x pecte d d urati o n f or eac h s u bject’s partici pati o n i n t he st u d y will be a p pr o xi matel y 1 4 wee ks. Wit h p ote ntial visit 
resc he d uli n g d ue t o weat her iss ues a n d i nc o m plete visits, t he d urati o n of a s u bject’s partici pati o n c o ul d ta ke u p t o 2 0 
wee ks.  
 
T he pla n ne d d urati o n of recr uit me nt is a p pr o xi matel y 9 m o nt hs.  
 
T he pla n ne d d urati o n of t he cli nical st u d y is a p pr o xi matel y 1 2 t o 1 5 m o nt hs.  
 
A p pr o xi matel y 6 7 5  s u bjects will be scree ne d f or a t otal of 5 7 0  s u bjects t o be ra n d o mize d ( 38 0 i n t he M A L D L -P D T 
ar m a n d 1 9 0  i n t he ve hicle D L-P D T ar m usi n g a 2: 1 ra n d o mizati o n rati o)  t o ha ve a p pr o xi matel y 1 0 0 s u bjects of M A L 
D L -P D T  ar m  c o m plete  t he  l o n g -ter m  f oll o w-u p  st u d y,  w h o  ha d  c o m plete res p o nse f or t he  pri mar y  e n d p oi nt. 
Ra n d o mizati o n is stratifie d b y st u d y ce nters usi n g t he I nteracti ve Res p o nse Tec h n ol o g y (I R T) S yste m.  
 
A p pr o xi matel y 6 0  st u d y ce nters are pla n ne d i n t he U nite d States wit h a p pr o xi matel y 8 s u bjects e nr olle d per ce nter . 
 
All  atte m pts will be ma de t o kee p t he st u d y ce nter staff a n d s u bjects bli n de d t hr o u g h o ut t he st u d y. Me m bers of t he 
st u d y ce nter staff, i ncl u di n g t he pr oce d ure o perat or, will n ot ha ve access t o t he ra n d o mize d treat me nt assi g n me nt.  
 
T o e ns ure d o u ble -bli n d a d mi nistrati o n of st u d y dr u g t he st u d y ce nter p har macist(s) or ot her q ualifie d pers o n nel w ill 
pre pare all M A L 1 6. 8 % crea m or ve hicle crea m treat me nts, acc or di n g t o t he c urre nt versi o n of t he p har mac y ma n ual 
pr o vi de d b y t he I R T s yste m.  
 
T he ra n d o mizati o n c o de w ill re mai n bli n de d t o all st u d y ce nter s a n d st u d y tea m me m bers u ntil c o m pleti o n of t he st u d y 
a n d after t he l oc k of t he st u d y data base. 
 
Pers o n nel fr o m S p o ns or, C R O, a n d i n vesti gati o nal ce nter s directl y i n v ol ve d wit h t he o n g oi n g c o n duct  of t he l o n g -ter m 
f oll o w-u p  st u d y  will  n ot  ha ve  access  t o  a n y  i nf or mati o n  t hat  ma y  lea d  t o  u n bli n di n g f or  t he o n g oi n g  mai nte na nce 
e val uati o n. 


 
R D. 0 6. S P R. 1 1 2 1 9 9  
 
 
Pa ge 1 1  of 4 3  
St atistic al A n al ysis Pl a n  
 
 
Versi o n Fi n al 2. 0, 0 6 -A P R- 2 0 2 1  
5  
E F FI C A C Y A N D S A F E T Y A S S E S S M E N T S 
Fi g ure 1 - St u d y Sc he m a  
 
* At Visit 6  ( Wee k 1 4 or Fi nal Visit), 1 2 wee ks after t he last D L -P D T treat me nt t h ose s u bjects w h o ac hie ve C o m plete 
Res p o nse  ( C R)  of  treate d  lesi o ns  will be  offere d  t he  o p p ort u nit y  t o  c o nti n ue  i n  t he  l o n g -ter m  f oll o w-u p  st u d y  t o 
e val uate rec urre nce of t he treate d lesi o ns 


 
R D. 0 6. S P R. 1 1 2 1 9 9  
 
 
Pa ge 1 2  of 4 3  
St atistic al A n al ysis Pl a n  
 
Versi o n Fi n al 2. 0, 0 6 -A P R- 2 0 2 1  
T a ble 1 - Sc he d ule of A ssess m e nts 
Visit  
1  
2  a 
2 b b  
3  
4  a 
4 b  b 
5  a, b 
6  a, b 
P ur p ose  Me dic al hist or y 
a n d l a bs  
First  
D L -P D T  
sessi o n 
If re q uire d 
F oll o w -u p  
1 wee k after  
1 st D L -P D T  
( visit 2 or 2 b)  
Sec o n d  
D L -P D T  
sessi o n 
If re q uire d 
F oll o w -u p  
1 wee k afte r 
2 n d  D L -P D T   
( visit 4 or 4 b) 
Fi n al  
1 2 wee ks after  
l ast D L -P D T  
Wee k  
Scree ni n g  
B aseli ne  
 
Wee k 1  
Wee k 2  
 
Wee k 3  
Wee k 1 4/ E T 
f 
Visit wi n d o w  -1 4 t o  -5  d a ys  
0  t o + 1 4 d a ys  
 
-2  t o + 1 4  d a ys  
0  t o + 1 4  d a ys  
 
-2  t o + 1 4  d a ys  
-2  t o + 2 8 d a ys  
I nf or me d C o nse nt (I C f or p hot o gra p h y as nee de d)  
X  
 
 
 
 
 
 
 
De m o gra p hics (i ncl u di n g F S T)  
X  
 
 
 
 
 
 
 
Me dical Hist or y  
X  
 
 
 
 
 
 
 
Pre vi o us T hera pies/ Pr oce d ures  
X  
 
 
 
 
 
 
 
Vital Si g ns/ P h ysical E xa mi nati o n  
X  
 
 
 
 
 
 
X  
I ncl usi o n/ E xcl usi o n Criteria 
X  
 
 
 
 
 
 
X  
He mat ol o g y/ Bl o o d C he mist r y/U A/ E C G  
X  
 
 
 
 
 
 
X  
Pre g na nc y Test c 
X  
X  
X  
 
X  
X  
 
X  
Weat her assess me nt  
 
X  
X  
 
X  
X  
 
 
P h ot o gra p h y ( Selecte d sites)  d 
 
X  
 
 
 
 
 
X  
A K ma p pi n g + c o u nti n g + gra di n g d 
 
X  
X  
 
X  
X  
 
X  
S u nscree n a p plicati o n  
 
X  
X  
 
X  
X  
 
 
Lesi o n dé bri de me nt a n d treat me nt a p plicati o n  
 
X  
X  
 
X  
X  
 
 
Ge ol ocalize d Satellite data a n d e x p os ure ti me  
 
X  
X  
 
X  
X  
 
 
St u d y dr u g(s) Dis pe nsi n g ( D) a n d Acc o u nta bilit y  ( A) 
 
X  
X  
 
X  
X  
 
 
S u bject Assess me nt of Pai n  
 
X  
X  
 
X  
X  
 
 
S u bject S ki n As pect Assess me nt d 
 
 
 
 
 
 
 
X  
S u bject S atisfacti o n Q uesti o n naire   
 
 
 
 
X  
X  
 
X  d 
Safet y V isit Q uesti o n  
 
 
 
X  
 
 
X  
 


 
R D. 0 6. S P R. 1 1 2 1 9 9  
 
 
Pa ge 1 3  of 4 3  
St atistic al A n al ysis Pl a n  
 
Versi o n Fi n al 2. 0, 0 6 -A P R- 2 0 2 1  
Visit  
1  
2  a 
2 b b  
3  
4  a 
4 b  b  
5  a, b 
6  a, b 
P ur p ose  Me dic al hist or y 
a n d l a bs  
First  
D L -P D T  
sessi o n 
If re q uire d 
F oll o w -u p  
1 wee k after  
1 st D L -P D T  
( visit 2 or 2 b)  
Sec o n d  
D L -P D T  
sessi o n 
If re q uire d 
F oll o w -u p  
1 wee k afte r 
2 n d  D L -P D T   
( visit 4 or 4 b) 
Fi n al  
1 2 wee ks after  
l ast D L -P D T  
Wee k  
Scree ni n g  
B aseli ne  
 
Wee k 1  
Wee k 2  
 
Wee k 3  
Wee k 1 4/ E T 
f 
Visit wi n d o w  -1 4 t o  -5  d a ys  
0  t o + 1 4 d a ys  
 
-2  t o + 1 4  d a ys  
0  t o + 1 4  d a ys  
 
-2  t o + 1 4  d a ys  
-2  t o + 2 8 d a ys  
A d verse E ve nts e 
X  
X  
X  
X  
X  
X  
X  
X  
C o nc o mita nt T hera pies/ Pr oce d ures  d 
 
X  
X  
X  
X  
X  
X  
X  
S u bjects wit h C o m plete Res p o nse e val uati o n a n d I C 
f or c o nti n uati o n i nt o l o n g-ter m f oll o w-u p st u d y  
 
 
 
 
 
 
 
X 
E xit F or m f 
 
 
 
 
 
 
 
X  
a) Visit s 2 a n d 4 ma y be dela ye d f or u p t o 2 wee ks i n case of u ns uita ble weat her c o n diti o ns at ra n d o mizati o n/treat me nt o utset. T hese p ost p o ne me nts will be a ut o maticall y a d de d t o t he ti me of 
sc he d ule d Visits 5 a n d 6  
b)  If s u bjects e x perie nce rai n d uri n g t he 2 h ours o f da yli g ht e x p os ure of eit her D L-P D T visit, t he y will be i nstr ucte d t o g o i n d o ors at t he i n vesti gati ve site a n d t he st u d y dr u g will be was he d off.  T he 
treat me nt will be c o nsi dere d i nc o m plete a n d s h o ul d be re peate d at a mi ni m u m i nter val of 2 wee ks, wit h a ma xi m u m i nter val of 4 wee ks. T here will be o nl y o ne atte m pt at retreat me nt of a n 
i nc o m plete treat me nt. T hese visits will be Visits 2 b a n d 4 b. If t he atte m pt at retreat me nt is als o i nc o m plete, t he s u bject will c o nti n ue i n t he st u d y. Li ke wise t hese re peat vis its will be a d de d t o t he 
ti me of sc he d ule d Visits 5 a n d 6.  
c) O nl y f or fe males of c hil d beari n g p ote ntial, uri ne at Visits 1, 2, 2 b (if a p plica ble), 4, 4 b (if a p plica ble) a n d 6  
d)  S h o ul d be perf or me d earlier if s u bject disc o nti n ues bef ore Visit 6  
e) A d verse E ve nts ha ve t o be c ollecte d fr o m t he ti me of t he I nf or me d C o nse nt si g nat ure  
f) 
E xit f or m s h o ul d be c o m plete d after s u bject data c ollecti o n has bee n c o m plete d f or s u bjects i n t he st u d y


 
R D. 0 6. S P R. 1 1 2 1 9 9  
 
 
Pa ge 1 4  of 4 3  
St atistic al A n al ysis Pl a n  
 
Versi o n Fi n al 2. 0, 0 6 -A P R- 2 0 2 1  
6  
E F FI C A C Y A N D S A F E T Y V A RI A B L E S  
6. 1  
Effic ac y V ari a bles  
 
Lesi o n R es p o nse 
At  Visit  2  ( bef or e  treat me nt),  t he  I n vesti gat or  will  ma p  t he  s u bject’s  lesi o ns,  c o u nt  t he m,  a n d  re p ort  t heir  se verit y 
acc or di n g t o criteria base d o n Olse n ( 1 9 9 1)  (see Ta ble 2 ). 
 
At Visits 2 b (if a p plica ble), 4, 4 b  (if a p plica ble) bef ore treat me nt a n d at Visit 6 / E T, t he se verit y of pre-e xisti n g, treate d 
A K lesi o ns t hat ha d bee n i de ntifie d a n d treate d pre vi o usl y will be rec or de d. If ne w A Ks de vel o p i n t he treat me nt area, 
t he y will be rec or de d, b ut n ot treate d n or i ncl u de d i nt o t he efficac y e val uati o ns.  
 
T a ble 2 - Lesi o n S e verit y G r a de S c ale 
Gr a de  
Se verit y  
Descri pti o n  
Gra de 1  
Mil d  
Sli g htl y pal pa ble, better felt t ha n see n  
Gra de 2  
M o derate  
M o deratel y t hic k, easil y felt a n d see n  
Gra de 3  
Se vere  
Ver y t hic k a n d/ or o b vi o u s acti nic kerat oses 
 
T he I n vesti gat or will be as ke d at Visits 2 b (if a p plica ble), 4, 4 b  (if a p plica ble) a n d 5/ E T t o i de ntif y eac h lesi o n treate d 
pre vi o usl y, a n d t he lesi o n res p o nse as a C R or a n o n -C R, as descri be d i n  Ta ble 3 . 
 
T a ble 3 - Lesi o n R es p o nse S c ore 
Res p o nse  
Sc ore  
Descri pti o n  
C o m plete res p o nse ( C R)   
1 
C o m plete disa p peara nce of t he lesi o n, vis uall y a n d b y pal pati o n  
N o n -c o m plete re sp o nse ( n o n -C R)   
0 
N o n -c o m plete disa p peara nce of t he lesi o n 
 
If all of t he treate d lesi o ns i n t he treat me nt area are assesse d t o be C R at 1 2 wee ks after t he last  D L -P D T sessi o n (Visit 
6 ), t he s u bject will be assesse d as a s u bject C R. If a n y of t he treate d lesi o ns i n t he treat me nt area are assesse d t o be 
n o n -C R, t he s u bject will be assesse d as a n o n-c o m plete res p o n der. T h ose s u bjects w h o are assesse d t o be C R, i.e., all 
treate d lesi o ns cleare d, at Visit 6  will be offere d t he o p p ort u nit y t o c o nti n ue i n t he l o n g -ter m f oll o w-u p st u d y, t o assess 
rec urre nce of lesi o ns treate d. 
6. 2  
S afet y V ari a bles  
Safet y  varia bles will be assess e d  f or all s u bjects at t he visit 1 ( u p o n si g ni n g of t he I C F) a n d at e ver y s u bse q ue nt visit. 
 
S u bject Assess m e nt of P ai n  
At Visit 2, 2 b (if a p plica ble), a n d Visit 4, 4 b  (if a p plica ble), after t he treatme nt sessi o n ( o nce ill u mi nati o n i n da yli g ht 
is c o m plete d), t he s u bject will assess t he ma xi mal pai n felt d uri n g da yli g ht e x p os ure. T he s u bject will c o m plete t his 
assess me nt f or all D L -P D T e x p os ures, b ot h c o m plete a n d i nc o m plete. T he pai n se nsati o n will be assesse d o n a n 1 1 -
p oi nt N u merical Rati n g Scale ( N R S), w here ' 0' is n o pai n at all a n d ' 1 0' is e xtre me pai n as s h o w n i n  Ta ble 4 . T he ce nter  


 
R D. 0 6. S P R. 1 1 2 1 9 9  
 
 
Pa ge 1 5  of 4 3  
St atistic al A n al ysis Pl a n  
 
Versi o n Fi n al 2. 0, 0 6 -A P R- 2 0 2 1  
pers o n nel will c ollect a n d re p ort t he s u bject’s self -assess me nt of pai n i n t he Pr oce d ure L o g. I n t he e ve nt t hat a s u bject 
re q uires a n i nter ve nti o n f or pai n s uc h as me dicati o n, it will t he n be rec or de d as a n A E i n t he e C R F. 
 
T a ble 4 - N u m eric al R ati n g Sc ale f or S u bject S elf-assess m e nt of P ai n  
0  
1  
2  
3  
4  
5  
6  
7  
8  
9  
1 0  
□  
□  
□  
□  
□  
□  
□  
□  
□  
□  
□ 
N o p ai n at all  
E xtre m e p ai n  
 
S afet y Visit Q uesti o n  
At Visits 3 a n d 5, partic ular atte nti o n is pai d t o A Es a n d e ve nts w hic h ca n be se q uelae of treat me nt.  
 
T he I n vesti gat or will a ns wer t he f oll o wi n g q uesti o n at eac h of Visit 3 a n d Visi t 5: 
 
D oes t he s u bject e x hi bit si g ns a n d sy m pt o ms of p ossi ble c o nt act se nsitiz ati o n ?  
 Y E S  
 N O  
 
If Y E S t he n, acc or di n g t o t he secti o ns 9. 2. 4. 2 a n d 9. 4. 4 of t he st u d y pr ot oc ol, if t he I n vesti gat or rec o g nizes si g ns a n d 
s y m pt o ms of p ossi ble c o ntact se nsitizati o n at ot her visits d uri n g t he st u d y, he/s he s h o ul d re p ort t hese as a n A d verse 
E ve nt of S pecial I nterest ( A E SI).  
 
Cli nic al assess m e nt of t he s u bject’s s ki n as pect  
At Visit 6 , f or eac h lesi o n t hat has res p o n de d c o m pletel y (see Ta ble 3 ), t he I n vesti gat or will assess t he s u bject’s s ki n 
as pect o n t he f oll o wi n g si g ns: scarri n g, atr o p h y, i n d urati o n, re d ness or c ha n ge i n pi g me ntati o n (see Ta ble 5 ). 
 
T he cli nical assess me nt of s ki n as pec t will be gra de d acc or di n g t o t he f oll o wi n g scale. 
 
T a ble 5 - Sc ale f or C li nic al A ssess m e nt of S u bject's S ki n A s pect 
Cli nic al Assess m e nt  
Sc ore  
Descri pti o n  
E xcelle nt  
3 
N o scarri n g, atr o p h y or i n d urati o n, a n d n o or sli g ht occ urre nce  
of re d ness or c ha n ge i n pi g me ntati o n c o m pare d t o a djace nt s ki n  
G o o d  
2 
N o  scarri n g,  atr o p h y  or  i n d urati o n,  b ut  m o derate  re d ness  or 
c ha n ge i n pi g me ntati o n c o m pare d t o a djace nt s ki n  
Fair  
1 
Sli g ht t o m o derate occ urre nce of scarri n g, atr o p h y or i n d urati o n  
P o or  
0 
E xte nsi ve occ urre nce of scarri n g, atr o p h y or i n d urati o n  
 
I n t he e ve nt of t he sc ore of 2 or less f or t he cli nical assess me nt of s u bject’s s ki n as pect, it will be rec or de d as a n A E i n 
t he e C R F. 
 
A d verse E ve nts  
A d verse e ve nts ( A Es) will be rec or de d d uri n g eac h visit ( Visits 1, 2, 3, 4 , 5 a n d 6 / E T) a n d at ot her visits ca use d b y 
p ost p o ne me nt of treat me nt or i nc o m plete treat me nt.  
 
All me dical e ve nts, w het her o bser ve d b y t he I n vesti gat or or re p orte d b y  t he s u bject, a n d w het her or n ot t h o u g ht t o be 
treat me nt-relate d, will be c o nsi dere d A Es a n d rec or de d o n t he a p pr o priate A E f or m. 


 
R D. 0 6. S P R. 1 1 2 1 9 9  
 
 
Pa ge 1 6  of 4 3  
St atistic al A n al ysis Pl a n  
 
Versi o n Fi n al 2. 0, 0 6 -A P R- 2 0 2 1  
 
A n A E is defi ne d as a n y u nt o war d me dical occ urre nce i n a cli nical st u d y, i n w hic h a s u bject is a d mi nistere d a me dici nal 
pr o d u ct t hat d oes n ot necessaril y ha ve a ca usal relati o ns hi p wit h t his treat me nt. A n A E ca n t heref ore be a n y u nfa v ora ble 
a n d u ni nte n de d si g n (i ncl u di n g a n a b n or mal la b orat or y fi n di n g), s y m pt o m, or disease te m p orall y ass ociate d wit h t he 
use of a me dici nal (i n vesti gati o nal) pr o d uct, w het her or n ot it is relate d t o t he  me dici nal (i n vesti gati o nal) pr o d uct. T his 
i ncl u des a n e xacer bati o n of pre-e xisti n g c o n diti o ns or e ve nts, i nterc urre nt ill nesses, dr u g i nteracti o n, or t he si g nifica nt 
w orse ni n g of t he i n dicati o n u n der  i n vesti gati o n, t hat is n ot rec or de d else w here i n t he e CR F u n der s pecific efficac y 
assess me nts. 
 
Refer t o t he st u d y pr ot oc ol f or f urt her details a b o ut A Es defi niti o n a n d ma na ge me nt.  
 
Cli nic al L a b or at or y E v al u ati o n 
T he  he mat ol o g y  la b orat or y  a nal yses,  cli nical  c he mistr y  la b orat or y  a nal yses,  a n d  uri nal yses  will  be perf or me d  at  a 
ce ntral la b orat or y. Sa m ples f or t he a nal yses will be c ollecte d at scree ni n g visit  a n d visit 6 / E T a n d/ or at a n y u nsc he d ule d 
visit . Refere nce ra n ges will be s u p plie d b y t he ce ntral la b orat or y a n d use d b y t he i n vesti gat or t o assess t he la b orat or y 
data f or cli nical si g nifica nce a n d pat h ol o gical c ha n ges.  
 
T he I n vesti gat or or me dicall y -q ualifie d s u b -i n vesti gat or m ust re vie w a n d e val uate la b orat or y val ues f or eac h s u bject 
i n a ti mel y ma n ner. St u d y ce nters s h o ul d refer t o t he c urre nt versi o n of t he la b orat or y ma n ual f or la b orat or y val ues 
o utsi de of n or mal li mits. F or eac h o ut -of -ra n ge la b orat or y res ult, t he I n vesti gat or or desi g nee will e val uate w het her 
he/s he c o nsi ders it t o be cli nicall y si g nifica nt ( C S), defi ne d as meeti n g at least 1 of t he f oll o wi n g c o n diti o ns: 
•  
T he a b n or malit y s u g gests a disease a n d/ or or ga n t o xicit y, or  
•  
T he a b n or malit y is of a de gree t hat re q uires a d diti o nal acti ve ma na ge me nt, e. g., disc o nti n uati o n of t he dr u g, 
cl ose o b ser vati o n, m ore fre q ue nt f oll o w-u p assess me nts, or f urt her dia g n ostic i n vesti gati o n .  
 
If t he I n vesti gat or o bser ves a C S la b orat or y res ult, t he test will be re peate d as s o o n as p ossi ble a n d t he s u bject will be 
m o nit ore d u ntil t he val ue ret ur ns t o n or mal a n d/ or a n a de q uate e x pla nati o n f or t he a b n or malit y is f o u n d.  
 
In vesti gat ors  will  als o  be  all o we d  t o  re peat  s pecific  la b orat or y  test(s)  or  pr oce d ure(s)  w here  he/s he  s us pects  a n 
i nacc urac y or false res ult, a n d w hic h ma y i m pact t he safet y of t he s u bject or t he i nter pretati o n of t he st u d y res ults; o nl y 
after disc ussi o n wit h t he me dical m o nit or.  
 
All  C S  o ut -of -ra n ge  la b orat or y  val ues  at  t he  scree ni n g  visit  will  be  rec or de d  (re p ort  a  dia g n osis  rat her  t ha n  t he 
la b orat or y val ue, w he ne ver p ossi ble). All C S o ut-of -ra nge la b orat or y val ues after t he scree ni n g visit are t o be re p or te d 
as a n A E if t his a b n or malit y was n ot prese nt at t he scree ni n g visit or is assesse d as ha vi n g w orse ne d si nce t he scree ni n g 
visit  (i.e.,  c ha n ge d  si g nifica ntl y  fr o m  t he  scree ni n g  visit).  W he ne ver  p ossi ble,  t he  I n vesti gat or  s h o ul d  pr o vi de  a 
dia g n osis of a n  A E w he n re p orti n g t he a b n or mal la b orat or y val ue.  
 
S u bjects s h o ul d be re mi n de d t o be well h y drate d bef ore all visits f or p hle b ot o m y p ur p oses. S u bjects s h o ul d fast f or at 
least 8 h o urs bef ore t he visits w he n bl o o d c he mistr y testi n g is pla n ne d, e xce pt f or t he scree ni n g visit. T he scree ni n g 
visit la b orat or y val ues m ust be a vaila ble bef ore t he baseli ne visit. La b orat or y testi n g c o n d ucte d i n a n o nfasti n g state 
will n ot be a pr ot oc ol de viati o n.  
 
T otal bl o o d v ol u mes t o be dra w n at eac h visit are pr o vi de d i n t he cl i nical la b orat or y ma n ual. A d diti o nal sa m ples ma y 
be re q uire d if me dicall y i n dicate d (e. g., at u nsc he d ule d visits f or safet y reas o ns, w he n a n a b n or mal la b orat or y val ue is 
o bser ve d a n d re q ui res a re-test). 


 
R D. 0 6. S P R. 1 1 2 1 9 9  
 
 
Pa ge 1 7  of 4 3  
St atistic al A n al ysis Pl a n  
 
Versi o n Fi n al 2. 0, 0 6 -A P R- 2 0 2 1  
6. 2. 5. 1  
He m at ol o g y 
He m o gl o bi n, he mat ocrit, w hite bl o o d cell c o u nt ( wit h differe ntial i ncl u di n g e osi n o p hils), re d bl o o d cell c o u nt, platelet 
c o u nt, mea n cell v ol u me a n d I N R . 
6. 2. 5. 2  
Bl o o d C he mistr y  
Creati ni ne, A S T, A L T, ga m ma gl uta m yltra nsferase, al kali ne p h os p hatase, lactate de h y dr o ge nase, t otal bilir u bi n, direct 
bilir u bi n ,  al b u mi n,  t otal  pr otei n,  uric  aci d,  s o di u m,  p otassi u m,  calci u m,  c hl ori de,  gl uc ose,  urea,  t otal  c h olester ol, 
tri gl yceri des,  l o w-de nsit y  li p o pr otei n  ( L D L),  hi g h-de nsit y  li p o pr otei n  ( H D L),  c reati ni ne  p h os p h o ki nase  ( C P K). 
Creati ni ne p h os p h o ki nase is oe nz y me test will be perf or me d o nl y if C P K is ele vate d t o > 2. 5 × U L N. T he I n vesti gat or 
s h o ul d als o c o ntact t he me dical m o nit or i n s uc h sit uati o ns. 
 
F or p ost me n o pa usal s u bjects (i.e., n o me nses f or 1 2 c o nsec uti ve m o nt hs), p ost me n o pa usal stat us will be c o nfir me d 
wit h a hi g h f ollicle -sti m ulati n g h or m o ne le vel i n t he p ost me n o pa usal ra n ge. 
6. 2. 5. 3  
Uri n al ysis  
p H, gl uc ose, ket o nes, bl o o d, pr otei n, le u k oc ytes, nitrites, bilir u bi n, ur o bili n o ge n a n d s pecific gra vit y . 
 
Vit al Si g ns  
Vital si g ns will be e val uate d at  scree ni n g a n d visit 6 / ET bef ore bl o o d sa m pli n g a n d/ or at a n y u nsc he d ule d visit . Vital 
si g ns will i ncl u de p ulse rate, s yst olic a n d diast olic bl o o d press ure (after t he s u bject has bee n sitti n g f or at least 1 5 
mi n utes), a n d b o d y te m perat ure. All a b n or mal val ues at t he scree ni n g vis it, i de ntifie d as C S b y t he I n vesti gat or will be 
rec or de d. A n y C S c ha n ges fr o m t he scree ni n g visit will be rec or de d as a n A E.  
 
P h ysic al E x a mi n ati o n 
C o m plete p h ysical e xa mi nati o n s h o ul d  be perf or me d at t he  scree ni n g a n d visit 6 / E T a n d/ or at a n y u nsc he d ule d visit . 
T he  e xa mi nati o n will  i ncl u de  assess me nts  of  t he  hea d,  ears,  e yes,  n ose,  t hr oat,  nec k  (i ncl u di n g  t h yr oi d), 
s ki n/i nte g u me ntar y  s yste m,  car di o vasc ular  s yste m,  res pirat or y  s yste m,  g astr oi ntesti nal  s yste m,  m usc ul os keletal 
s yste m, l y m p h n o des, a n d ner v o us s yste m. 
 
I n vesti gat ors s h o ul d assess all a b n or mal fi n di n gs f or cli nical si g nifica nce. All C S a b n or mal fi n di n gs at t he scree ni n g 
visit will be rec or de d i n t he me dical hist or y f or m. A n y  C S c ha n ges fr o m t he scree ni n g visit will be rec or de d as a n A E . 
 
Electr oc a r di o gr a ms 
A 1 2 -lea d Electr ocar di o gra m ( E C G) will be perf or me d a n d rea d ce ntrall y at scree ni n g a n d visit 6 / E T a n d/ or at a n y 
u nsc he d ule d visit usi n g t he E C G mac hi ne pr o vi de d. Electr ocar di o gra ms f or eac h s u bject s h o ul d be o btai ne d usi n g t he 
sa me electr ocar dio gra p h mac hi ne w he ne ver p ossi ble. Electr ocar di o gra ms will be perf or me d i n t he s u pi ne p ositi o n at 
t he ti me p oi nts descri be d i n t he sc he d ule of assess me nts a n d bef ore a n y sc he d ule d vital si g n meas ure me nts a n d bl o o d 
dra ws.  S u bjects  s h o ul d  be  m o nit ore d  f or  p ot e ntiall y  C S  E C G  res ults  (refer  t o  t he  c urre nt  versi o n  of  t he  ce ntral 
la b orat or y ma n ual). Tests wit h a b n or mal res ults t hat are dee me d C S s h o ul d be re peate d t o e ns ure re pr o d uci bilit y of 
t he a b n or malit y. A n y a b n or malities c o nsi dere d t o be C S b y t he I n vesti gat or are t o be rec or de d as A Es a n d disc usse d 
wit h t he me dical m o nit or, as nee de d . 


 
R D. 0 6. S P R. 1 1 2 1 9 9  
 
 
Pa ge 1 8  of 4 3  
St atistic al A n al ysis Pl a n  
 
Versi o n Fi n al 2. 0, 0 6 -A P R- 2 0 2 1  
6. 3  
Ot her V ari a bles  
 
S atisf acti o n Q uesti o n n aires  
At  Visit 4 (4 b if  a p plica ble,  sec o n d  D L-P D T)  a n d visit  6 / E T,  t he  s u bjects will  be  as ke d  t o  c o m plete  satisfacti o n 
q uesti o n naire s (see A p pe n dices 1, secti o n 1 5. 1, a n d 2, secti o n 1 5. 2, of t he st u d y pr ot oc ol).  
 
T he p ur p ose of t hese q uesti o n naires is t o rec or d s u bjects' feeli n gs a n d o pi ni o ns (efficac y, safet y, vis ua l as pect of t he 
s ki n, c o n ve nie nce, etc.) c o ncer ni n g t he treat me nts t he y recei ve d. 
 
We at her Ass ess m e nt  
At Visit 2 ( 2 b if a p plica ble), a n d Visit 4 (4 b if a p plica ble), t he visits at w hic h t he D L-P D T sessi o ns are perf or me d, t he 
I n vesti gat or  s h o ul d  e ns ure  t hat  t he  weat her  c o n diti o ns  are  a p pr o priate  t o  be gi n  t he  pr ocess  of  D L-P D T.  Bef ore  
ra n d o mizi n g/treati n g  t he  s u bject,  t he  I n vesti gat or  s h o ul d  deter mi ne  t hat  s u bjects  will  be  a ble  t o  s pe n d  2  h o urs 
c o mf orta bl y o ut d o ors i n a m bie nt c o n diti o ns, after t he A Ks ha ve bee n  pre pare d f or D L -P D T. T he I n vesti gat or s h o ul d 
als o assess t he li keli h o o d of rai n o ver t he ne xt 3 h o urs b y c o ns ulti n g t he l ocal weat her f orecast usi n g  t he i nter net (e. g., 
weat her. g o v). If it is rai ni n g or t here is a si g nifica nt pr o ba bilit y of rai n i n t he e n s ui n g 3 h o urs, treat me nt s h o ul d be 
p ost p o ne d.  
 
S u bject E x p os ure Ti m e a n d P pI X  Effecti ve D ose  
T he s u bject will be as ke d t o sta y o utsi de u n der direct li g ht e x p os ure or s ha de f or 2 c o nsec uti ve h o urs . 
 
T he e x p os ure s h o ul d n ot start less t ha n 2 h o urs bef ore s u nset. Trai ne d pers o n nel fr o m t he i n vesti gati o nal ce nter will 
be as ke d t o n ote all c ha n ges i n e x p os ure c o n diti o ns a n d t heir d urati o n ( Start/ E n d) i n or der t o be a ble t o deter mi ne t he 
effecti ve d urati o n of t he da yli g ht e x p os ure f or a gi ve n s u bject ( S u bject E x p os ure Ti me)  (see secti o n 8. 4. 4. 3 of t he 
st u d y pr ot oc ol). T he l ocati o n of t he s u bject will be ge ol ocalize d d uri n g t he S u bject E x p os ure Ti me. Rec or ds of all 
assess me nts li n ke d t o Weat her assess me nt a n d S u bject E x p os ure Ti me will be re p orte d i n t he Pr oce d ure L o g . 
 
Fr o m  t he  ge ol ocalizati o n  a n d  ti me  of  t he  s u bject’s  da yli g ht  ill u mi nati o n,  satellite  data  will  be  use d  t o  deter mi ne 
irra dia nce  d uri n g  t he  s u bject  e x p os ure  ti me.  T he  P pI X  effecti ve  d ose  f or  eac h  s u bject’s  da yli g ht  e x p os ure  will  be 
calc ulate d usi n g t hese para meters . 
 
Pr oce d ures f or S us pecte d Se nsitiz ati o n ( Rec h alle n ge a n d P atc h I n gre die nt Test)  
If  a  s u bject  e x perie nces  s us pecte d  s ki n  se nsitizati o n  (c o ntact  aller g y),  t he  f oll o wi n g  acti o ns  s h o ul d  be  ta ke n  t o 
c haracterize t he e ve nt : 
•  
St o p t he st u d y dr u g.  
•  
Ta ke a p h ot o of t he affecte d area a n d t he n o n -affecte d s urr o u n di n g s ki n.  
•  
D oc u me nt  t he e ve nt as a n A E SI a n d re p ort t he e ve nt t o t he S y ne os Healt h Safet y a n d P har mac o vi gila nce gr o u p 
wit hi n 2 4 h o urs as descri be d f or S A E i n Secti o n 9. 2. 4 . 3 of t he st u d y pr ot oc ol. 
 
a)  
I n c ase of s us pici o n of aller gic c o nt act der m atitis 
•  
After all si g ns a n d s y m pt o ms ha ve res ol ve d (after a mi ni m u m of 2 wee ks), perf or m a rec halle n ge test 
wit h t he assi g ne d st u d y dr u g. Patc h tests will be s u p plie d b y Gal der ma.  


 
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Versi o n Fi n al 2. 0, 0 6 -A P R- 2 0 2 1  
•  
E ns ure t he s u bject has n ot bee n u n der a n y treat me nt wit h c ortic oster oi ds or a nti hista mi nes of a n y r o ute 
of  a d mi nistrati o n t he wee k bef ore testi n g . 
•  
E ns ure t hat t he s ki n o n t he bac k has n ot bee n e x p ose d t o t he s u n or artificial ultra vi olet  s o urces t he wee k 
bef ore testi n g.  
•  
A p pl y a n a p pr o priate q ua ntit y of t he assi g ne d st u d y pr o d uct t o fill i n t he c u p ule of t he test c ha m ber t o a 
naï ve  z o ne o n t he bac k eit her t he ri g ht or left si de of t he ce nter  li ne ( or t he i n ner f orear m if t he bac k 
ca n n ot be teste d).  If n o test c ha m ber is a vaila ble o n site, patc h test u nits will be pr o vi de d. T he use of 
se mi-occl usi ve c o n diti o ns  ca n b e preferre d de pe n di n g o n t he irrita nt p ote ntial of t he st u d y pr o d uct a n d 
t he i nte nsit y of t he reacti o n t hat was o bser ve d.  T he met h o d t o be use d s h o ul d be disc usse d wit h t he 
S p o ns or, see  Ta ble 6 . 
•  
C h o ose a s ki n site t hat  was n ot pre vi o usl y i n v ol ve d i n t he i nfla m mat or y s ki n reacti o n o n t he bac k. C o ver 
t he test c ha m ber f or 4 8 h o urs wit h a h y p oaller ge nic ta pe. 
•  
Patie nt s h o ul d be i nf or me d a b o ut a v oi di n g e xercise, s h o wers, a p plicati o n of t oiletries pr o d ucts, t o kee p 
t he test s yste m dr y 
•  
After 4 8 h o urs, re m o ve t he test c ha m ber a n d e val uate t he site a n d ta ke p h ot os after eac h rea di n g:  
 
at a p pr o xi matel y 3 0 mi n utes after patc h test re m o val ( 1st rea di n g) a n d,  
 
2 4 t o 4 8 h o urs later (i.e., 7 2 or 9 6 h o urs after a p plicati o n) ( 2 n d rea di n g)  
 
if t he res ult of t he sec o n d rea di n g is e q ui v ocal, t he I n vesti gat or or at t he S p o ns or’s re q uest, ma y 
perf or m a n  o pti o nal 3r d rea di n g at 9 6 t o 1 2 0 h o urs later (i.e., 6 t o 7 da ys after a p plicati o n of t he 
patc h)  
 
Pict ures  of  eac h  rea di n g  a n d  t he  rea di n g  res ults  s h o ul d  be  se nt  t o  t he  S y ne os  Healt h  a n d 
P har mac o vi gila nce  
 
T a ble 6 - P atc h Test Pr oce d ure  
D ur ati o n of st u d y  
Pr o d uct a p plic ati o n  
1st re a di n g +  
P h ot o gr a p hs  
2 n d re a di n g +  
P h ot o gr a p hs  
3r d re a di n g ( o pti o n al)  + 
P h ot o gr a p hs  
4 8 h o urs  
4 8  h o urs  after  st u d y 
pr o d uct  a p plicati o n  ( 3 0 
mi n utes  after  patc h  test 
re m o val) 
7 2 t o 9 6 h o urs after st u d y 
pr o d uct a p plicati o n ( 2 4 t o 
4 8 h o urs  after  patc h  test 
re m o val) 
6  or  7  da ys  after  st u d y 
pr o d uct a p plicati o n ( 9 6 t o 
1 2 0  h o urs  after  patc h 
re m o val) 
 
•  
Use  t he  f oll o wi n g  sc ori n g  s yste m  ( S pie wa k  2 0 0 8 ,  see  Ta ble  7)  use d  b y  t he  I nter nati o nal  C o ntact 
Der matitis Researc h Gr o u p (I C D R G) at eac h rea di n g:  
 
T a ble 7 - S us pecte d S e nsitiz ati o n  - C h alle n ge R e acti o n G r a di n g S c ale 
Sc ore  
M or p h ol o g y  
I nter pret ati o n 
- 
N o reacti o n  
Ne gati ve  
? 
Fai nt, n o n -pal pa ble er yt he ma  
D o u btf ul reacti o n 
+ 
Pal pa ble er yt he ma ( m o derate e de ma or i nfiltrate), pa p ules n ot prese nt 
or scarce, vesicles n ot prese nt  
Wea k p ositi ve reacti o n  
+ +  
Str o n g i nfiltrate, n u mer o us pa p ules, vesicles prese nt  
Str o n g p ositi ve reacti o n  
+ + +  
Er yt he ma, i nfiltrati o n, c o nfl ue nt vesicles, b ullae or ulcerati o n 
E xtre me p ositi ve reacti o n  


 
R D. 0 6. S P R. 1 1 2 1 9 9  
 
 
Pa ge 2 0  of 4 3  
St atistic al A n al ysis Pl a n  
 
Versi o n Fi n al 2. 0, 0 6 -A P R- 2 0 2 1  
Sc ore  
M or p h ol o g y  
I nter pret ati o n 
I R 
I nfla m mati o n  s har pl y  li mite d  t o  t he  e x p ose d  area,  lac k  of  i nfiltrate, 
s mall  petec hiae,  p ust ules,  a n d  effl oresce nces  ot her  t ha n  pa p ules  a n d 
vesicles  
Irrita nt reacti o n 
N T   
 
N ot teste d  
•  
At t he last rea di n g, t he I n vesti gat or will pr o vi de a n assess me nt re gar di n g a p ossi ble  se nsitizati o n reacti o n 
usi n g t he f oll o wi n g scale  (see Ta ble 8 ): 
 
T a ble 8 - S us pecte d S e nsitiz ati o n - C h alle n ge C o ncl usi o n S c ale 
Sc ore  
Se nsitiz ati o n Re acti o n  
0 
Ne gati ve, mi g ht i ncl u de a n irrita nt reacti o n  
1 
E q ui v ocal  
2 
P ositi ve  
•  
I n case of a bse nce of reacti o n after q u otati o n wit h t he I nter nati o nal C o ntact Der matitis Researc h Gr o u p 
(I C D R G scale), t he s u bject ma y res u me treat me nt if a p pr o priate. 
•  
If t he rec halle n ge is p ositi ve or e q ui v ocal after q u otati o n wit h t he I C D R G scale, n otif y S y ne os Healt h 
i m me diatel y. E xce pt s pecific sit uati o ns, a ne w series of patc h tests will be i nitiate d as directe d b y t he 
S p o ns or ( wit h i n di vi d ual i n gre die nts at differe nt c o nce ntrati o ns if a p plica ble, a n d p ossi bl y ne gati ve a n d 
p ositi ve c o ntr ols) after a mi ni m u m of a n a d diti o nal t w o wee ks  ( b ut n ot later t ha n 6 m o nt hs) a n d after all 
si g ns a n d s y m pt o ms ha ve res ol ve d. If a rec halle n ge test is re q uire d, re peat t his pr ocess a b o ve be gi n ni n g 
wit h t he test c ha m ber ste p . 
 
b)  
I n c ase of s us pici o n of i m m e di ate c o nt act s ki n re acti o n (s uc h as urtic ari a)  
 
A case -b y -case a p pr oac h will be a p plie d a n d t he pr oce d ure t o f oll o w will be disc usse d wit h t he S p o ns or.  
 


 
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St atistic al A n al ysis Pl a n  
 
Versi o n Fi n al 2. 0, 0 6 -A P R- 2 0 2 1  
7  
E F FI C A C Y E N D P OI N T S  
7. 1  
Pri m ar y E n d p oi nt  
•  
T he pri mar y e n d p oi nt is t he s u bject c o m plete res p o nse, defi ne d as t he pr o p orti o n of s u bjects wit h c o m plete 
cleara nc e of all A K lesi o ns treate d, at 1 2 wee ks after t he last  D L -P D T (Visi t 6), c o m pari n g M A L crea m wit h 
ve hicle crea m . 
7. 2  
Sec o n d ar y E n d p oi nts  
•  
Lesi o n  c o m plete  res p o nse,  defi ne d  as  t he  perce nt  re d ucti o n  fr o m  baseli ne  i n  t he  n u m ber  of  cleare d  treate d 
lesi o ns, at 1 2 wee ks after t he last  D L -P D T treat me nt ( Visit 6), c o m pari n g M A L crea m wit h ve hicle crea m. 
•  
S u bject partial res p o nse, defi ne d as t he pr o p orti o n of s u bjects wit h 7 5 % or greater re d ucti o n fr o m baseli ne i n 
t he n u m ber of cleare d treate d lesi o ns, at 1 2 wee ks after t he last D L -P D T treat me nt ( Visit 6), c o m pari n g M A L 
crea m wit h ve hicle crea m . 
8  
P O P U L A TI O N S A N A L Y Z E D  
T he f oll o wi n g a nal ysis p o p ulati o ns will be use d t o a nal yze t he st u d y data . 
8. 1  
I nte nt-t o- Tre at P o p ul ati o n 
T he  i nte nt -t o-treat  (I T T)  p o p ulati o n  will  c o m prise  all  ra n d o mize d  s u bjects.  All  pri mar y  a n d  sec o n dar y  efficac y 
e n d p oi n ts will be a nal yze d base d o n t he I T T p o p ulati o n. T he I T T p o p ulati o n will be t he pri mar y p o p ulati o n f or all 
efficac y a nal yses .  
8. 2  
S afet y P o p ul ati o n 
T he safet y ( S A F) p o p ulati o n will c o nsist of all r a n d o mize d s u bjects w h o recei ve d at least o ne a p plicati o n of st u d y 
dr u g. All safet y data will be s u m marize d base d o n t he safet y p o p ulati o n . 
All safet y data f or n o n -ra n d o mize d s u bjects w h o use d st u d y dr u g mista ke nl y will be liste d se paratel y.  
Ra n d o mize d  s u bjects  f or  w h o m  it  is  u nclear  w het her  t he y recei ved at  least  o ne  a p plicati o n  of  st u d y  dr u g  will  be 
i ncl u de d i n t he safet y p o p ulati o n as ra n d o mize d. 
8. 3  
Per Pr ot oc ol P o p ul ati o n 
T he  per  pr ot oc ol  ( P P)  p o p ulati o n  will  c o m prise  all  s u bjects  i n  t he  I T T  p o p ulati o n  w h o  ha ve  n o  maj or  pr ot oc ol 
de viati o ns t hat w o ul d ha ve a si g nifica nt effect o n t he efficac y of t he st u d y treat me nt. T he P P p o p ulati o n will be use d 
f or t he se nsiti vit y a nal yses of pri mar y e n d p oi nt t o assess t he r o b ust ness of st u d y c o ncl usi o n.  
 
P ote ntial maj or p r ot oc ol de viati o ns ma y i ncl u de b ut are n ot li mite d t o: 
•  
Eli gi bilit y de viati o ns (i ncl usi o n/e xcl usi o n criteria).  
•  
I m pr o per a d mi nistrati o n of st u d y me dicati o n. 
•  
N o nc o m plia nce  wit h  st u d y  me dicati o n  d ue  t o  2  c o nsec uti ve  i nc o m plete  treat me nts  or  per  t he  I n vesti gat o r’s 
discreti o n . 
•  
N o nc o m plia nce  wit h  st u d y  pr oce d ures  if  t he  c o nse q ue nce  of  n o nc o m plia nce  w o ul d  c o m pr o mise  eit her  t he 
s u bject’s safet y a n d/ or t he st u d y i nte grit y, pri mar y e n d p oi nt, a n d/ or is n ot i n li ne wit h G o o d Cli nical Practice 
( G C P)/I C H g ui deli nes. 


 
R D. 0 6. S P R. 1 1 2 1 9 9  
 
 
Pa ge 2 2  of 4 3  
St atistic al A n al ysis Pl a n  
 
Versi o n Fi n al 2. 0, 0 6 -A P R- 2 0 2 1  
•  
Use o f pr o hi bite d c o nc o mita nt t hera pies. 
•  
A d mi nistrati ve err or:  
 
Acci de ntal u n bli n di n g; 
 
Me dicati o n dis pe nsi n g err ors ; 
 
A K l esi o n c o u nts a n d e val uati o n perf or me d b y a n o n -a p pr o ve d e val uat or. 
 
T he  fi nal  list  of  maj or  pr ot oc ol  de viati o n  criteria , s u bjects  w h o  ha ve  a ny  maj or  pr ot oc ol  de viati o ns a n d  s u bjects 
e xcl u de d fr o m t he p er p r ot oc ol ( P P) po p ulati o n will be d oc u me nte d i n t he bli n d re vie w me m o bef ore data base l oc k.  
Decisi o ns ma de re gar di n g t he e xcl usi o n of s u bjects a n d/ or s u bject data fr o m a nal yses will be ma de pri o r t o data base 
l oc k a n d u n bli n di n g a n d will be d oc u me nte d i n bli n d re vie w me m o. 
9  
S A M P L E SI Z E C O N SI D E R A TI O N  
A l o n g -ter m f oll o w u p st u d y is pla n ne d t o gat her data a b o ut rec urre nces at ar o u n d t he 1 year ti me p oi nt after t he D L- 
P D T treat me nts.  
 
S u bjects w h o ac hie ve a c o m plete res p o nse at Visit 6, 1 2 wee ks after t he last D L -P D T treat me nt, will be offere d t he 
o p p ort u nit y t o be f oll o we d i n a 9 -m o nt h l o n g -ter m f oll o w-u p st u d y t o ha ve treate d lesi o ns assesse d f or rec urre nce. T he 
sa m ple size calc ulati o n is base d o n pro vi di n g e n o u g h s u bjects t o e na ble t he detecti o n of a treat me nt diffe re nce i n t he 
pri mar y e n d p oi nt a n d e ns uri n g a p pr o xi matel y 1 0 0 s u bjects  of M A L D L -P D T ar m  c o m plete t he l o n g -ter m f oll o w-u p 
st u d y, w h o ha d c o m plete res p o nse f or t he pri mar y e n d p oi nt. 
 
A p pr o xi matel y 6 7 5 s u bjects will be scree ne d f or a t otal of 5 7 0 s u bjects t o be ra n d o mize d ( 3 8 0 i n t he M A L D L -P D T 
ar m a n d 1 9 0 i n t he ve hicle crea m D L -P D T ar m usi n g a 2: 1 ra n d o mizati o n rati o) t o ha ve a p pr o xi matel y 1 0 0 s u bjects  
of M A L D L -P D T ar m  c o m plete t he l o n g -term f oll o w -u p st u d y, w h o ha d c o m plete res p o nse f or t he pri mar y e n d p oi n t. 
T his st u d y will ha ve m ore t ha n 9 0 % p o wer t o detect a 3 0 % differe nce bet wee n M A L D L -P D T ( 4 5 % c o m plete res p o nse 
rate) a n d ve hicle D L-P D T ( 1 5 % c o m plete res p o nse rate) a n d wit h a t y pe I err or of 0. 0 0 1 2 5 ass u mi n g 7 % s u bjects will 
be n o n -e val ua ble at 1 2 wee ks  after t he last D L -P D T f or t he pri mar y e n d p oi nt, 7 0 % of s u bjects ac hie vi n g a c o m plete 
res p o nse at 1 2 wee ks after t he last D L-P D T will be e nr olle d i n t he L T f oll o w -u p st u d y a n d dr o p o ut rate  of 1 0 % d uri n g 
L T f oll o w -u p st u d y.  
1 0  
S T A TI S TI C A L M E T H O D S A N D D A T A C O N SI D E R A TI O N S  
1 0. 1  
Ge ner al C o nsi der ati o ns  
 
B aseli ne  
F or  statistical  a nal yses  p ur p ose,  baseli ne  is  defi ne d  as  t he  last  meas ure me nt  pri or  t o  t he  first D L -P D T  treat me nt 
(re gar dless of treat me nt c o m pleti o n stat us). 
 
C ha n ge fr o m baseli ne a n d perce nt c ha n ge fr o m baseli ne will be calc ulate d as:  
 
𝐶𝐶ℎ𝑎𝑎𝑎𝑎𝑎𝑎𝑎𝑎 𝑓𝑓𝑓𝑓𝑓𝑓𝑓𝑓 𝐵𝐵𝑎𝑎𝐵𝐵𝑎𝑎𝐵𝐵𝐵𝐵𝑎𝑎𝑎𝑎= 𝑃𝑃𝑓𝑓𝐵𝐵𝑃𝑃𝐵𝐵𝑎𝑎𝐵𝐵𝑎𝑎𝐵𝐵𝐵𝐵𝑎𝑎𝑎𝑎 𝑉𝑉𝑎𝑎𝐵𝐵𝑉𝑉𝑎𝑎−𝐵𝐵𝑎𝑎𝐵𝐵𝑎𝑎𝐵𝐵𝐵𝐵𝑎𝑎𝑎𝑎 𝑉𝑉𝑎𝑎𝐵𝐵𝑉𝑉𝑎𝑎 
 
𝑃𝑃𝑎𝑎𝑓𝑓𝑃𝑃𝑎𝑎𝑎𝑎𝑃𝑃 𝐶𝐶ℎ𝑎𝑎𝑎𝑎𝑎𝑎𝑎𝑎 𝑓𝑓𝑓𝑓𝑓𝑓𝑓𝑓 𝐵𝐵𝑎𝑎𝐵𝐵𝑎𝑎𝐵𝐵𝐵𝐵𝑎𝑎𝑎𝑎= �𝐵𝐵𝑎𝑎𝐵𝐵𝑎𝑎𝐵𝐵𝐵𝐵𝑎𝑎𝑎𝑎 𝑉𝑉𝑎𝑎𝐵𝐵𝑉𝑉𝑎𝑎≠0 ⇒
1 0 0 ∙𝑃𝑃𝑓𝑓𝐵𝐵𝑃𝑃𝐵𝐵𝑎𝑎𝐵𝐵𝑎𝑎𝐵𝐵𝐵𝐵𝑎𝑎𝑎𝑎 𝑉𝑉𝑎𝑎𝐵𝐵𝑉𝑉𝑎𝑎−𝐵𝐵𝑎𝑎𝐵𝐵𝑎𝑎𝐵𝐵𝐵𝐵𝑎𝑎𝑎𝑎 𝑉𝑉𝑎𝑎𝐵𝐵𝑉𝑉𝑎𝑎
𝐵𝐵𝑎𝑎𝐵𝐵𝑎𝑎𝐵𝐵𝐵𝐵𝑎𝑎𝑎𝑎 𝑉𝑉𝑎𝑎𝐵𝐵𝑉𝑉𝑎𝑎
𝐵𝐵𝑎𝑎𝐵𝐵𝑎𝑎𝐵𝐵𝐵𝐵𝑎𝑎𝑎𝑎 𝑉𝑉𝑎𝑎𝐵𝐵𝑉𝑉𝑎𝑎= 0 ⇒
𝑀𝑀𝐵𝐵𝐵𝐵𝐵𝐵𝐵𝐵𝑎𝑎𝑎𝑎                                                                     
 


 
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St atistic al A n al ysis Pl a n  
 
Versi o n Fi n al 2. 0, 0 6 -A P R- 2 0 2 1  
 
Missi n g D ates  M a n a ge me nt  
•  
Start Date I m p utati o n of A d verse E ve nts : 
 
I m p utati o n of a d verse e ve nt e n d date has t o  be d o ne bef ore i m p utati o n of e ve nt start date.  
 
C o m pletel y missi n g: I m p ute t o t he first st u d y treat me nt date.  
 
Missi n g da y a n d m o nt h: I m p ute t o Ja n uar y 1
st, u nless year is t he sa me as year of first st u d y treat me nt 
d ose t he n i m p ute t o t he first st u d y treat me nt date.  
 
Missi n g da y: I m p ute t o t he 1 st of t he m o nt h, u nless m o nt h a n d year are t he sa me as m o nt h a n d year of 
first st u d y treat me nt d ose t he n i m p ute t o t he first st ud y treat me nt date.  
 
If i m p ute d e ve nt start date is after e ve nt e n d date (i m p ute d or n ot), set t he e ve nt start date t o t he i m p ute d 
e ve nt e n d date. 
 
•  
Start Date I m p utati o n of Pri or/ C o nc o mita nt T hera pies a n d Me dical/ S ur gical Pr oce d ures:  
 
I m p utati o n of t hera p y/ proce d ure e n d date has t o  be d o ne bef ore i m p utati o n of t hera p y/ pr oce d ure start 
date.  
 
C o m pletel y missi n g: I m p ute t o t he first st u d y treat me nt date.  
 
Missi n g da y a n d m o nt h: I m p ute t o Ja n uar y 1
st, u nless year is t he sa me as year of first st u d y treat me nt 
d ose t he n i m p ute t o t he first st u d y treat me nt date. 
 
Missi n g da y: I m p ute t o t he 1
st of t he m o nt h, u nless m o nt h a n d year are t he sa me as m o nt h a n d year of 
first st u d y treat me nt d ose t he n i m p ute t o t he first st u d y treat me nt date. 
 
If  i m p ute d  t hera p y/ pr oce d ure  start date  is  after  t hera p y/ pr oce d ure  e n d  date  (i m p ute d  or  n ot),  set  t he 
t hera p y/ pr oce d ure start date t o t he i m p ute d t hera p y/ pr oce d ure e n d date.  
 
•  
Start Date I m p utati o n of Me dical Hist or y Diseases :  
 
I m p utati o n of disease  e n d date has t o be d o ne bef ore i m p utati o n of disease start date. 
 
C o m pletel y missi n g: Lea ve it missi n g.  
 
Missi n g da y a n d m o nt h: I m p ute t o Ja n uar y 1 st. 
 
Missi n g da y: I m p ute t o t he 1
st of t he m o nt h.  
 
If i m p ute d disease  start date is after disease  e n d date (i m p ute d or n ot), set t he disease  start date t o t he 
i m p ute d disease  e n d date. 
 
•  
E n d  Date  I m p utati o n  of  A d verse  E ve nts,  Pri or/ C o nc o mita nt  T hera p ies  a n d  Me dical/ S ur gical  Pr oce d ures, 
Me dical Hist or y Diseases : 
 
C o m pletel y missi n g a n d fla g ge d as bei n g o n g oi n g: Lea ve i t missi n g. 
 
C o m pletel y missi n g a n d n ot fla g ge d as bei n g o n g oi n g: I m p ute t o t he last c o ntact date.  
 
Missi n g da y a n d m o nt h: I m p ute t o Dece m be r 3 1st, u nless year is t he sa me as last c o ntact date t he n i m p ute 
t o t he last c o ntact date. 
 
Missi n g da y: I m p ute t o t he last da y of t he m o nt h, u nless year a n d m o nt h are t he sa me as year a n d m o nt h 
of last c o ntact date t he n i m p ute t o t he last c o ntact date.   
 
Re fere nce St a rt D ate a n d A n al ysis D a y 
T he first st u d y treat me nt date will be t he refere nce start date. 
 
A nal ysis  da y  will  be  calc ulate d  fr o m  t he  first  st u d y  treat me nt  date  a n d  will  be  use d  t o  s h o w  start/e n d  da y  of 
assess me nts, e ve nts, t hera pies or pr oce d ures. 
 


 
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I n t he sit uati o n w here t he assess me nt/e ve nt/t hera p y/ pr oce d ure/ disease date is f ull y missi n g  a n d ca n n ot be i m p ute d (i.e. 
w he n e ve nt, t hera p y or pr oce d ure is re p orte d as bei n g o n g oi n g) , a nal ysis da y will be missi n g. 
 
Descri pti ve St atisti cs  
F or t he descri pt i ve statistics, u nless ot her wise n ote d, t he cate g orical varia bles will be s u m marize d b y fre q uenc y a n d 
perce nta ge  ( n,  %)  f or  eac h  res p o nse  cate g or y , a n d  t he  c o nti n u o us  varia bles  will  be  s u m marize d  usi n g  sta n dar d 
descri pti ve statistics ( n, mea n, sta n dar d de viati o n, me dia n, first a n d t hir d q uartile, mi n  a n d ma x).  
 
St atistic al Tests  a n d C o nfi de nce I nter v als 
A t w o-si de d t y pe I err or α = 0. 0 0 1 2 5  will be use d t o declare statistical si g nifica nce f or t he pri mar y a n d t he sec o n dar y 
e n d p oi nts. C o nfi de nce i nter vals ( CIs)  will be t w o -si de d wit h b ot h 9 9. 8 7 5% c o vera ge a n d 9 5 % c o vera ge f or t he pri mar y 
a n d  t he  sec o n dar y  e n d p oi nts . T he  f oll o wi n g fla g gi n g  c o n ve nti o ns  will  be  a p plie d  f or  t he  p -val ues  of  all  statistical 
testi n g: 
 
•  
p- val ue s < 0. 0 0 1 2 5  will be fla g ge d wit h t w o asteri s ks (e. g. " 0. 0 0 1 2 1 * *"); 
•  
0. 0 0 1 2 5 ≤ p-val ue s < 0. 0 1  will be fla g ge d wit h o ne asteris k  (e.g. " 0. 0 0 9 3 2  *") . 
 
Deci m al Precisi o n  
U nless ot her wise n ote d, t he f oll o wi n g r o u n di n g c o n ve nti o ns will be a p plie d:  
•  
mea ns , me dia ns , first a n d t hir d q uartiles will be r o u n de d  a n d prese nte d t o o ne m ore deci mal di git t ha n t he s o urce 
data;  
•  
c o nfi de nce i nter vals of m ea ns a n d me dia ns will be r o u n de d a n d prese nte d t o o ne m ore deci mal di git t ha n t he 
s o urce data; 
•  
sta n dar d  de viati o ns a n d  sta n dar d  err ors  will  be  r o u n de d  a n d  prese nte d  t o t w o  m ore  deci mal  di gits  t ha n  t he 
s o urce data; 
•  
mi ni ma a n d ma xi ma will be prese nte d t o t he sa me n u m ber of deci mal di gits as t he s o urce data;  
•  
p r o p orti o ns will be prese nte d as perce nta ges ( n ot as fracti o n of u nit); 
•  
perce nta ges  greater t ha n or e q ual t o 0. 1  will  be r o u n de d a n d prese nte d t o o ne deci mal di git , perce nta ges  l o wer 
t ha n 0. 1 a n d greater t ha n 0 will be prese nte d as ' < 0. 1' , perce nta ges  e q ual t o 0 will n ot be prese nte d;  
•  
c o nfi de nce i nter vals of perce nta ges  will be r o u n de d a n d prese nte d t o o ne deci mal di git;  
•  
sta ndar d err ors of perce nta ges  will be r o u n de d a n d prese nte d t o t w o deci mal di git s; 
•  
p- val ues greater t ha n or e q ual t o 0. 0 0 0 0 1 will be r o u n de d a n d prese nte d t o fi ve deci mal di gits, w hilst p -val ues 
l o wer t ha n 0.0 0 0 0 1 will be prese nte d as '<. 0 0 0 0 1 '. 
 
S oft w are  V ersi o n  
All a nal yses will be perf or me d usi n g S A S ®  s oft ware Versi o n 9. 4 or hi g her. 


 
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St atistic al A n al ysis Pl a n  
 
Versi o n Fi n al 2. 0, 0 6 -A P R- 2 0 2 1  
1 0. 2  
St u d y S u bjects  
 
Dis p ositi o n of S u bjects  
T he n u m ber a n d perce nta ge of s u bjects ( n, %) will be s u m marize d b y treat me nt gr o u p (ra n d o mize d s u bjects o nl y) a n d 
o verall f or t he f oll o wi n g cate g ories:  
 
•  
S u bjects scree ne d;  
•  
S u bjects eli gi ble;  
•  
Scree n fail ures;  
 
Reas o ns f or scree n fail ure;  
•  
Scree n fail ures  d ue t o C O VI D -1 9 ; 
 
Re as o ns f or scree n fail ure  d ue t o C O VI D -1 9 ; 
•  
S u bjects ra n d o mize d;  
•  
S u bjects ra n d o mize d  b ut disc o nti n ue d bef ore treat me nt ; 
 
R eas o ns f or st u d y disc o nti n uati o n bef ore treat me nt;   
•  
S u bjects ra n d o mize d b ut disc o nti n ue d bef ore treat me nt  d ue t o C O VI D -1 9 ; 
 
Reas o ns f or st u d y disc o nti n uati o n bef ore treat me nt d ue t o C O VI D -1 9 ;  
•  
S u bject ra n d o mize d a n d treate d;  
•  
S u bject ra n d o mize d a n d treate d w h o c o m plete d t he st u d y;  
•  
S u bject ra n d o mize d a n d treate d w h o disc o nti n ue d t he treat me nt ;  
•  
S u bject ra n d o mize d a n d treate d w h o disc o nti n ue d  t he treat me nt d ue t o C O VI D -1 9;  
•  
S u bject ra n d o mize d a n d treate d w h o disc o nti n ue d t he st u d y;  
 
Reas o ns f or st u d y disc o nti n ua ti o n; 
•  
S u bject ra n d o mize d a n d treate d w h o disc o nti n ue d t he st u d y  d ue t o C O VI D -1 9 ;  
 
Reas o ns f or st u d y disc o nti n uati o n  d ue t o C O VI D -1 9 ; 
•  
S u bjects ra n d o mize d affecte d b y C O VI D -1 9 relate d st u d y disr u pti o n s; 
•  
S u bjects ra n d o mize d affecte d b y C O VI D -1 9 relate d st u d y disr u pti o ns i m pacti n g efficac y ; 
•  
S u bjects ra n d o mize d affecte d b y C O VI D -1 9 relate d st u d y disr u pti o ns i m pacti n g safet y. 
 
All dis p ositi o n data will be list e d.  A listi n g of all s u bjects affecte d b y t he C O VI D -1 9 relate d st u d y disr u pti o n s i ncl usi ve 
of t he descri p ti o n of h o w t he i n di vi d ual's partici pati o n was altere d will be pr o vi de d. 
 
A n al ysis P o p ul ati o ns 
T he n u m ber a n d perce nta ge ( n, %) of s u bjects  i n eac h a nal ysis p o p ulati o n (I T T, S A F, P P) will be s u m marize d b y 
treat me nt gr o u p a n d o verall. A nal ysis p o p ulati o ns da ta will be liste d. 
 
De m o gr a p hic a n d B aseli ne C h ar acteristics  
Descri pti ve s u m mar ies of t he f oll o wi n g de m o gra p hic data a n d baseli ne c haracteristics will be prese nte d  b y treat me nt 
gr o u p a n d o verall  usi n g t he I T T p o p ulati o n. 
 
•  
A ge  
•  
A ge gr o u p  
 
≤ 3 9 years ol d  
 
4 0 -6 4 years ol d  
 
≥ 6 5 years ol d  


 
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Versi o n Fi n al 2. 0, 0 6 -A P R- 2 0 2 1  
•  
Se x  
 
Male  
 
Fe male  
•  
Et h nicit y  
 
His pa nic or Lati n o  
 
N ot His pa nic or Lati n o  
 
N ot Re p orte d  
 
U n k n o w n  
•  
Race  
 
W hite  
 
Blac k or Africa n A merica n  
 
Asia n  
 
A merica n I n dia n or Alas ka Nati ve  
 
Ha waiia n Nati ve or Ot her Pacific Isla n der  
 
Ot her  
 
M ulti ple  
•  
Fitz patri c k s ki n t y pe 
 
T y pe I  
 
T y pe II  
 
T y pe III  
 
T y pe I V  
 
T y pe V  
 
T y pe VI  
•  
Fitz patric k s ki n t y pe  gr o u p  
 
T y pe I, II a n d III 
 
T y pe I V, V a n d VI  
•  
N u m ber of baseli ne A K lesi o n s of gra de 1  
•  
N u m ber of baseli ne A K lesi o n s of gra de 2 
•  
N u m ber of baseli ne A K lesi o n s 
•  
Classifie d n u m ber o f baseli ne A K lesi o ns 
 
4- 8 A K lesi o ns 
 
9- 1 2 A K lesi o ns 
•  
Baseli ne A K gra de  
 
Gra de 1 ( mil d) A K  
 
Gra de 2 ( m o derate) A K  
 
All de m o gra p hic data a n d baseli ne c haracteristics will be liste d . 
 
Acc o u nti n g of S u bjects  
N u m ber a n d perce nta ge ( n, %) of s u bjects  f or eac h cli nical visit a n d eac h a nal ysis visit will be prese nte d b y treat me nt 
gr o u p a n d o verall usi n g t he I T T P o p ulati o n. 


 
R D. 0 6. S P R. 1 1 2 1 9 9  
 
 
Pa ge 2 7  of 4 3  
St atistic al A n al ysis Pl a n  
 
Versi o n Fi n al 2. 0, 0 6 -A P R- 2 0 2 1  
1 0. 3  
Pr ot oc ol D e vi ati o ns 
Maj or  pr ot oc ol  de viati o ns , maj or  pr ot oc ol  de viati o ns  lea di n g  t o  t he  e xcl usi o n  fr o m  t he  P P  p o p ulati o n a n d  maj or 
pr ot oc ol de viati o ns d ue t o C O VI D -1 9 will be s u m marize d usi n g fre q ue nc y a n d perce nta ge ( n, %) f or eac h de viati o n 
c o de d ter m b y treat me nt gr o u p a n d o verall usi n g  t he I T T p o p ulati o n. All pr ot oc ol de viati o ns will be liste d.  
1 0. 4  
Me dic al Hist or y, P ri or a n d C o nc o mit a nt T her a pies a n d  Pr oce d ures  
F or statistical a nal ysis p ur p oses, pri or t hera pies/ pr oce d ures are defi ne d as t h ose e n di n g bef ore t he da y of first treat me nt; 
c o nc o mita nt t hera pies/ pr oce d ures are defi ne d as t h ose starti n g bef ore t he da y of first treat me nt a n d  o n g oi n g o n t he da y  
of first treat me nt a n d  as t h ose starti n g o n t he da y of  first treat me nt or after . If a s u bject d oes n ot u n der g o  treat me nt, all 
t hera pies/ pr oce d ures of t hat s u bject  will be  classifie d as pri or.  
 
Pre vi o us a n d c o nc o mita nt t hera pies / me dicati o ns will be c o de d u si n g W H O Dr u g Dicti o nar y ( Marc h 1, 2 0 1 9, B 3/ C 3 
f or mat). Me dical hist or y diseases a n d pri or  a n d c o nc o mita nt me dical/s ur gical pr oce d ures  will be c o de d usi n g Me d D R A 
dicti o nar y  ( versi o n 2 2. 0). 
 
A s u m mar y ta ble will be pr o vi de d f or eac h of t he f oll o wi n g usi n g IT T p o p ulati o n b y treat me nt gr o u p a n d o verall:  
 
•  
N u m ber  a n d  perce nta ge  ( n,  %)  of  s u bjects  w h o  ha d  me dical  hist or y  diseases  b y  S yste m  Or g a n  Class  a n d 
Preferre d Ter m.  
•  
N u m ber a n d perce nta ge ( n, %) of s u bjects  w h o ha d pri or  t hera pies/ me dicati o ns b y A T C le vels 2, 3 a n d Preferre d 
Ter m.  
•  
N u m ber a n d perce nta ge ( n, %) of s u bjects  w h o ha d c o nc o mita nt t hera pies/ me dicati o ns b y A T C le vels 2, 3 a n d 
Prefe rre d Ter m. 
•  
N u m ber a n d perce nta ge ( n, %) of s u bjects  w h o ha d pri or  me dical/s ur gical pr oce d ures b y S yste m Or ga n Class 
a n d Pr eferre d Ter m. 
•  
N u m ber a n d perce nta ge ( n, %) of s u bjects  w h o ha d c o nc o mita nt me dical/s ur gical pr oce d ures b y S yste m Or ga n 
Class a n d Prefe rre d Ter m. 
 
L isti n gs of all me dical hist or y disease s, pri or a n d c o nc o mita nt t hera pies/ me dicati o ns a n d me dical/s ur gical pr o ce d ures 
will be pr o vi de d.  
1 0. 5  
C o m pli a nce  
Si nce t he s u bjects will recei ve M A L crea m or ve hicle crea m at t he i n vesti gati o nal ce nter , a n d ha ve it a p plie d b y t he 
i n vesti gat or, treat me nt c o m plia nce will be assesse d t hr o u g h t he act ual treat me nt sessi o ns a n d a d here nce t o t he differe nt 
ste ps of t he pr oce d ure a n d ti mi n g. N o n-c o m plia nces will be re p orte d as pr ot oc ol de viati o ns.  
 
St u d y d urati o n (e x presse d as n u m ber of da ys) will be calc ulate d as t he date of e n d of partici pati o n  mi n us t he date of 
first treat me nt ( or t he date of ra n d o mizati o n, f or ra n d o mize d s u bjects n ot u n der g oi n g treat me nt) pl us o ne  a n d will be 
s u m marize d b y descripti ve statistics usi n g I T T p o p ulati o n b y treat me nt gr o u p a n d o verall.  
 
Treat me nt  d urati o n  (e x presse d  as  n u m ber  of  da ys)  will  be  calc ulate d  as  t he  date  of  last treat me nt (c o m plete  or 
i nc o m plete) mi n us t he date of first treat me nt (c o m plete or i nc o m plete) pl us o ne a n d will be s u m marize d b y descri pti ve 
statistics usi n g I T T p o p ulati o n b y treat me nt gr o u p a n d o verall.  
 
T he n u m ber a n d perce nta ge ( n, %) of  s u bjects w h o di d n ot c o m plete neit her t he first n or t he sec o n d treat me nt, t he 
n u m ber a n d perce nta ge ( n, %) of s u bjects w h o c o m plete d t he first treat me nt o nl y , t he n u m ber a n d perce nta ge ( n, %) 
of s u bjects w h o c o m plete d t he sec o n d treat me nt o nl y  a n d t he n u m ber a n d perce nta ge ( n, %) of s u bjects w h o c o m plete d 
b ot h first a n d sec o n d treat me nt s will be s u m marize d usi n g I T T p o p ulati o n b y treat me nt gr o u p a n d o verall. 


 
R D. 0 6. S P R. 1 1 2 1 9 9  
 
 
Pa ge 2 8  of 4 3  
St atistic al A n al ysis Pl a n  
 
Versi o n Fi n al 2. 0, 0 6 -A P R- 2 0 2 1  
 
All c o m plia nce data will be liste d.  
1 0. 6  
Effic ac y A n al ysis 
Pri mar y i nfere nce f or efficac y a nal ysis will  be base d o n t he I T T p o p ulati o n at  wee k 1 4,  1 2 wee ks after t he last  D L -
P D T ( Visit 6 ).  
 
All efficac y data (i ncl u di n g efficac y  data of i nc o m plete treat me nts) will be liste d.  
 
A n al ysis of t he Pri m ar y E n d p oi nt  
T he h y p ot hesis test f or t he pri mar y e n d p oi nt ca n b e f or mall y defi ne d  as f oll o ws: 
 
�𝐶𝐶0 : 𝑎𝑎𝑎𝑎𝑎𝑎𝑎𝑎= 𝑓𝑓𝑓𝑓𝑓𝑓ℎ𝑓𝑓𝐵𝐵𝑎𝑎𝐵𝐵
𝑎𝑎𝐵𝐵:𝐵𝐵𝑎𝑎𝑎𝑎𝑃𝑃≠ 𝑓𝑓𝐵𝐵𝑃𝑃ℎ𝐵𝐵𝑎𝑎𝐵𝐵𝑎𝑎 
 
w here Π M A L  is t he pr o p orti o n of s u bjects ac hie vi n g a c o m plete res p o nse at 1 2 wee ks after t he last  M A L D L -P D T a n d 
Π Ve hicle  is t he pr o p orti o n of s u bjects ac hie vi n g a c o m plete res p o nse at 1 2 wee ks after t he last  ve hicle D L -P D T.  
 
T he h y p ot hesis test f or t he pri mar y e n d p oi nt will be e val uate d o n t he I T T p o p ulati o n at t he t w o -si de d si g nifica nce 
le vel α = 0. 0 0 1 2 5. Efficac y will be clai me d if t he bet wee n treat me nt differe nce o n t he pri m ar y e n d p oi nt is statisticall y 
si g nifica nt wit h a p-val ue < 0. 0 0 1 2 5. T his res ult will pr o vi de a n acce pta ble le vel of e vi de nce of efficac y, i n prese nce 
of g o o d i nter nal c o nsiste nc y acr oss pri mar y a n d sec o n dar y e n d p oi nts i n t he a bse nce of a sec o n d pi v otal st u d y.  
 
T he pr o p orti o n of s u bjects wit h c o m plete cleara nce of all A K lesi o ns treate d at eac h p ost -baseli ne a nal ysis visit  will 
be s u m marize d descri pti vel y b y treat me nt gr o u p s ( o verall a n d b y a nal ysis ce nt ers). T he pr o p orti o n of s u bjects wit h 
c o m plete cleara nce of all A K lesi o ns treate d at 1 2 wee ks after t he last  D L -P D T ( Visit 6)  will be a nal yze d usi n g t he 
C oc hra n -Ma ntel -Hae nszel ( C M H) test stratifie d b y a nal ysis ce nter (see defi niti o n i n secti o n 1 0. 6. 4. 4 ). N o c o nti n uit y 
c orrecti o n  will  be  use d .  T he  p-val ue  f or  t he  treat me nt  c o m paris o n  ( M A L  D L -P D T  vs.  ve hicle  D L -P D T)  will  be 
calc ulate d fr o m t he ge neral ass ociati o n statistic of t he stratifie d C M H test. Differe nce i n pr o p orti o ns bet wee n treat me nt 
gr o u ps  a n d  t he 9 9. 8 7 5 % 
a n d  9 5 % c o nfi de nce  i nter val s of  t he  differe nce  will  be  base d  o n  t he  lar ge  sa m ple 
a p pr o xi mati o n  met h o d  f or  bi nar y  data  a n d  will  be  calc ulate d  usi n g  t he  met h o d  descri be d  i n  t he  H ui pi n g  Z ha n g 
" Pr o p orti o n differe nce a n d c o nfi de nce i nter val base d o n C oc hra n -Ma ntel -Hae nszel met h o d i n stratifie d m ulti -ce nter 
cli nical  trial",  2 0 1 6,  P har ma S U G  C hi na  2 0 1 6,  Pa per  2 5  [ 1 ]. I n  a d diti o n,  t he  pr o p orti o n  of  s u bjects  wit h  c o m plete 
cleara nce of all A K lesi o ns treate d at 1 2 wee ks after t he last  D L -P D T (Visit 6 ) f or eac h treat me nt gr o u p will als o be 
prese nte d.  
 
F or t he pri mar y a nal ysis, all s u bjects o n t he I T T p o p ulati o n wit h missi n g data f or t he pri mar y e n d p oi nt will be classifie d 
as n o n -res p o n ders re gar dless of treat me nt all ocati o n (see secti o n 1 0. 6. 4. 2 ). 
 
T he c o nsiste nc y of t he treat me nt effect acr oss a nal ysis ce nters will be e val uate d usi n g gra p hical met h o ds ( F orest pl ot).  
C o nfi de nce i nter vals of t he differe nce i n pr o p orti o ns wi t hi n t he a nal ysis ce nters  will be calc ulate d usi n g t he Ne wc o m be 
met h o d wit h o ut a c o nti n uit y c orrecti o n, base d o n t he t w o i n di vi d ual Wils o n c o nfi de nce i nter vals . 
 
A bar c hart a n d li ne pl ots will be pr o d uce d o ver ti me f or eac h treat me nt gr o u p t o s u m marize t he c o m plete res p o n ders. 
 
Se nsiti vit y A n al yses of Pri m ar y E n d p oi nt 
T o assess t he r o b ust ness of t he pri mar y efficac y res ults, t he f oll o wi n g se nsiti vit y a nal yses will be c o n d ucte d:  
 


 
R D. 0 6. S P R. 1 1 2 1 9 9  
 
 
Pa ge 2 9  of 4 3  
St atistic al A n al ysis Pl a n  
 
Versi o n Fi n al 2. 0, 0 6 -A P R- 2 0 2 1  
1.  
T he pri mar y  a nal ysis  will  be  re peate d  o n  t he I T T  p o p ulati o n  b y  i m p uti n g  missi n g  data usi n g  MI  ( M ulti ple 
I m p utati o n) u n der t he Missi n g At Ra n d o m ( M A R) ass u m pti o n (see secti o n 1 0. 6. 4. 2  f or f urt her details). 
2.  
T he  pri mar y  a nal ysis  will  be  re peate d  o n  t he I T T  p o p ulati o n  b y  i m p uti n g  missi n g  dat a  usi n g  MI  ( M ulti ple 
I m p utati o n) base d o n t he Patter n-Mi xt ure M o del u n der t he missi n g n ot at ra n d o m ( M N A R) ass u m pti o n, b y  
usi n g t he pr ofiles fr o m ve hicle D L -P D T s u bjects wit h o bser ve d data t o i m p ute missi n g data  (see secti o n 1 0. 6. 4. 2  
f or f urt her details). 
3.  
T he pri mar y  a nal ysis  will  be  re peate d  o n  t he I T T  p o p ulati o n  b y  i m p uti n g  missi n g  data usi n g  MI  ( M ulti ple 
I m p utati o n) base d o n t he Patter n-Mi xt ure M o del u n der t he missi n g n ot at ra n d o m ( M N A R) ass u m pti o n i n or der 
to perf or m a ti p pi n g -p oi nt a nal ysis  (see secti o n 1 0. 6. 4. 2  f or f urt her details). 
4.  
T he pri mar y a nal ysis will be re peate d o n t he I T T p o p ulati o n b y i m p uti n g missi n g  data usi n g Last O bser vati o n 
Carrie d F o r war d ( L O C F). 
5.  
O bser ve d Case ( O C) a nal ysis o n t he I T T p o p ulati o n.  
6.  
T he pri mar y a nal ysis will be re peate d o n t he P P p o p ulati o n.  
1 0. 6. 2. 1  
I m p act o n t he Pri m ar y E n d p oi nt of C O VI D -1 9 rel ate d st u d y disr u pti o n s 
T o  assess  t he  i m pact o n  t he pri mar y  efficac y  res ults  of  C O VI D -1 9  relate d  st u d y  disr u pti o n s  (e. g.  treat me nt 
disc o nti n uati o n, missi n g assess me nts, re m ote visits, etc.), t he f oll o wi n g se nsiti vit y a nal ys is will be c o n d ucte d: 
 
1.  
T he pri mar y e n d p oi nt will be a nal yze d usi n g a l o gistic re gressi o n m o del wit h treat me nt, a n al ysis ce nter a n d 
oc c urre nce  fla g of C O VI D -1 9 relate d st u d y disr u pti o n s i m pacti n g efficac y res ults as fi xe d effects . A ll s u bjects 
o n t he I T T p o p ulati o n wit h missi n g data f or t he pri mar y e n d p oi nt will be classifie d as n o n -res p o n ders re gar dless 
of treat me nt all ocati o n (see sect i o n 1 0. 6. 4. 2 ). 
2.  
T he  pri mar y  e n d p oi nt  will  be  a nal yze d  usi n g  a  l o gistic  re gressi o n  m o del  wit h treat me nt,  a nal ysis  ce nter, 
occ urre nce  fla g of C O VI D -1 9 relate d st u d y disr u pti o n s i m pacti n g efficac y res ults a n d i nterac ti o n of treat me nt 
a n d  occ urre nce  fla g  of C O VI D -1 9  relate d  st u d y  disr u pti o n s  i m pacti n g  efficac y  res ults  as  fi xe d  effects. A ll 
s u bjects o n t he I T T p o p ulati o n wit h missi n g data f or t he pri mar y e n d p oi nt will be classifi e d as n o n -res p o n ders 
re gar dless of treat me nt all ocati o n (see secti o n 1 0. 6. 4. 2 ). T he i nteracti o n of treat me nt a n d occ urre nce  fla g of 
C O VI D -1 9 relate d st u d y disr u pti o n s i m pacti n g efficac y res ults will be dee me d statisticall y si g nifica nt if t he p-
val ue f or  t he i nteracti o n ter m is l o wer t ha n 0. 1 a n d, i n t his case, t he pri mar y a nal ysis will be re peate d se paratel y 
i n t he t w o s u b gr o u ps of s u bjects affecte d a n d n ot affecte d b y C O VI D-1 9 relate d  st u d y disru pti o n s i m pacti n g 
efficac y res ults.  
1 0. 6. 2. 2  
I m p act o n t he Pri m ar y En d p oi nt of s u bjects of Site  
 
Site  
  ( Dr. 
) wa s n o n -res p o nsi ve. T his  pre ve nte d  S o urce  Data  Verificati o n  fr o m  bei n g  perf or me d. T he 
e C R Fs  of  s u bjects  scree ne d  a n d  ra n d o mize d  at  t his site  w ere  n ot  si g ne d  b y  t he  i n vesti gat or a n d  q ueries  were  n ot 
a ns were d.  Data ca n n ot be verifie d a n d q uerie d.  
 
T o assess t he i m pact of s u bjects of Site  
 o n t he pri mar y efficac y res ults , a se nsiti vit y a nal ysis f or t he pri mar y 
e n d p oi nt will be perf or me d  o n t he I T T p o p ulati o n b y  re peati n g t he pri mar y a nal ysis wit h t he e xcl usi o n of  s u bjects 
ra n d o mize d at t his site. 
 
A n al ysis of Sec o n d ar y E n d p oi nts  
T he h y p ot hesis test s f or t he sec o n dar y e n d p oi nts ca n be f or mall y defi ne d as f oll o ws: 
 
P P D
P P D
P P D
P P
D


 
R D. 0 6. S P R. 1 1 2 1 9 9  
 
 
Pa ge 3 0  of 4 3  
St atistic al A n al ysis Pl a n  
 
Versi o n Fi n al 2. 0, 0 6 -A P R- 2 0 2 1  
�𝐶𝐶0 : µ𝑎𝑎𝑎𝑎𝑎𝑎= µ 𝑎𝑎𝑓𝑓ℎ𝑓𝑓𝑓𝑓𝑓𝑓𝐵𝐵
𝑎𝑎𝐵𝐵: µ𝑎𝑎𝐵𝐵𝐵𝐵≠µ 𝑎𝑎𝑎𝑎ℎ𝑃𝑃𝑓𝑓𝐵𝐵𝑃𝑃 
 
w here µ M A L  is t he mea n perce nt re d ucti o n fr o m baseli ne i n t he n u m ber of cleare d treate d lesi o ns at 1 2 wee ks after t he 
last M A L D L -P D T treat me nt ( Visit 6) a n d µ Ve hicle  is t he mea n perce nt re d ucti o n fr o m baseli ne i n t he n u m ber of cleare d 
treate d lesi o ns at 1 2 wee ks after t he last ve hicle D L -P D T treat me nt ( Visit 6 ) a n d 
 
�𝐵𝐵0 : 𝑎𝑎𝐵𝐵𝑎𝑎𝐵𝐵= 𝐵𝐵𝑎𝑎𝑎𝑎ℎ𝑉𝑉𝑎𝑎𝐵𝐵𝑉𝑉
𝑎𝑎𝐵𝐵:𝑎𝑎𝐵𝐵𝑎𝑎𝐵𝐵≠ 𝐵𝐵𝑎𝑎𝑎𝑎ℎ𝑉𝑉𝑎𝑎𝐵𝐵𝑉𝑉 
 
w here π M A L  is t he pr o p orti o n of s u bjects wit h 7 5 % or greater re d ucti o n fr o m baseli ne i n t he n u m ber of cleare d treate d 
lesi o ns at 1 2 wee ks after t he last M A L D L -P D T treat me nt ( V isit 6 ) a n d πVe hicle  is t he pr o p orti o n of s u bjects wit h 7 5 % 
or greater re d ucti o n fr o m baseli ne i n t he n u m ber of cleare d treate d lesi o ns at 1 2 wee ks after t he last ve hicle D L -P D T 
treat me nt ( Visit 6). 
 
T he h y p ot hesis tests f or t he sec o n dar y e n d p oi nts will be  e val uate d o n t he I T T p o p ulati o n at t he t w o -si de d si g nifica nce 
le vel α = 0. 0 0 1 2 5. T he a dj ust me nt f or m ulti ple c o m paris o ns is descri be d i n secti o n 1 0. 6. 4. 5 . 
 
T he n u m ber of cleare d treate d lesi o ns at eac h a nal ysis visit, t he r e d ucti o n fr o m baseli ne  a n d t he perce nt re d ucti o n fr o m 
baseli ne  i n t he n u m ber of cleare d treate d lesi o ns at eac h p ost -baseli ne a nal ysis visit  will be s u m marize d descri pti vel y 
b y treat me nt gr o u ps ( o verall a n d b y a nal ysis ce nters ). T he perce nt re d ucti o n fr o m baseli ne i n t he n u m ber of cleare d 
treate d  lesi o ns  at  1 2  wee ks after  t he  last  D L -P D T  treat me nt  ( Visit  6)  will  be  a nal yze d  usi n g  a n  A N C O V A  wit h  
treat me nt,  a nal ysis  ce nter (see  defi niti o n  i n  secti o n 1 0. 6. 4. 4 ) a n d  baseli ne A K  lesi o n  c o u nt  as  fi xe d  effects;  t he 
differe nce  i n  perce nt  re d ucti o n  be t wee n  M A L  D L-P D T  a n d  ve hicle  D L -P D T,  t he  9 9. 8 7 5 % a n d  9 5 % c o nfi de nce 
i nter vals of t he differe nce a n d t he p -val ue will be ge nerate d fr o m t he A N C O V A m o del.  
 
F or a nal ysi s of perce nt re d ucti o n fr o m baseli ne i n t he n u m ber of cleare d treate d lesi o ns at 1 2 wee ks after t he last  D L -
P D T treat me nt ( Visit 6), missi n g c o u nts of lesi o ns will be i m p ute d usi n g MI ( M ulti ple I m p utati o n) u n der t he Missi n g 
At Ra n d o m ( M A R) ass u m pti o n. It i s e x pecte d t hat t he patter n of missi n g data will be m o n ot o nic, wit h sli g ht de viati o ns 
bei n g c orrecte d b y t he Mar k o v C hai n M o nte Carl o ( M C M C) met h o d of t he MI pr oce d ure. Li near re gressi o n will be 
e m pl o ye d t o m o del t he missi n g lesi o n c o u nt data, wit h t he f ol l o wi ng c o variates i ncl u de d i n t he i m p utati o n m o del: 
treat me nt a n d n o n-missi n g data fr o m earlier ti me p oi nts  (see secti o n 1 0. 6. 4. 2 ). 
 
Li ne pl ots will be pr o d uce d o ver ti me f or eac h treat me nt gr o u p t o s u m marize t he  mea n perce nt re d ucti o n fr o m baseli ne 
i n t he n u m ber of cleare d treate d lesi o ns. 
 
T he pr o p orti o n of s u bjects wit h 7 5 % or greater re d ucti o n fr o m baseli ne i n t he n u m ber of cleare d treate d lesi o ns at eac h 
p ost -baseli ne will be s u m marize d descri pti vel y b y treat me nt gr o u ps ( o verall a n d b y a nal ysis ce nters ). T he pr o p orti o n 
of s u bjects wit h 7 5 % or greater re d ucti o n fr o m baseli ne i n t he n u m ber of cleare d treate d lesi o ns at 1 2 wee ks after t he 
last D L -P D T treat me nt ( Visit 6)  will be a nal yze d usi n g t he C oc hra n -Ma ntel - Hae nszel ( C M H) test stratifie d b y a nal ysis 
ce nter  (see  defi niti o n  i n  secti o n 1 0. 6. 4. 4 ).  N o  c o nti n uit y  c orrecti o n  will  be  use d.  T he  p-val ue  f or  t he  treat me nt 
c o m paris o n  ( M A L  D L -P D T  vs.  ve hicle  D L -P D T )  will  be  calc ulate d  fr o m  t he  ge neral  ass ociati o n  statistic  of  t he 
stratifie d  C M H  test.  Differe nce  i n  pr o p orti o ns  bet wee n  treat me nt  gr o u ps  a n d  t he  9 9. 8 7 5 % a n d  9 5 % c o nfi de nce 
i nter vals of  t he  differe nce  will  be  base d  o n  t he  lar ge  sa m ple  a p pr o xi mati o n  met h o d  f or  bi nar y  data a n d  will  be 
calc ulate d usi n g t he met h o d descri be d i n t he H ui pi n g Z ha n g " Pr o p orti o n differe nce a n d c o nfi de nce i nter val base d o n 
C oc hra n -Ma ntel -Hae nszel met h o d i n stratifie d m ulti -ce nter cli nical trial", 2 0 1 6, P har ma S U G C hi na 2 0 1 6, Pa per 2 5 
[1 ]. I n a d diti o n, t he pr o p orti o n of s u bjects wit h 7 5 % or greater re d ucti o n fr o m baseli ne i n t he n u m ber of cleare d treate d 
lesi o ns at 1 2 wee ks after the last  D L -P D T treat me nt ( Visit 6) f or eac h treat me nt gr o u p will als o be prese nte d. 
 
F or t he a nal ysis of pr o p orti o n of s u bjects wit h 7 5 % or greater re d ucti o n fr o m baseli ne i n t he n u m ber of cleare d treate d 
lesi o ns at 1 2 wee ks after t he last  D L -P D T treat me nt ( Visit 6), all s u bjects of t he I T T p o p ulati o n wit h missi n g data will 
be clas sifie d as n o n-res p o n ders re gar dless of treat me nt all ocati o n (see secti o n 1 0. 6. 4. 2 ). 
 


 
R D. 0 6. S P R. 1 1 2 1 9 9  
 
 
Pa ge 3 1  of 4 3  
St atistic al A n al ysis Pl a n  
 
Versi o n Fi n al 2. 0, 0 6 -A P R- 2 0 2 1  
A bar c hart a n d li ne pl ots will be pr o d uce d o ver ti me f or eac h treat me nt gr o u p t o s u m marize t he partial  res p o n ders. 
 
St atistic al  a n d A n al ytic al I ss ues 
1 0. 6. 4. 1  
A dj ust m e nt f or C o v ari ates 
T he a nal ysis of perce nt re d ucti o n fr o m baseli ne i n t he n u m ber of cleare d treate d lesi o ns at 1 2 wee ks after t he last  D L -
P D T treat me nt ( Visit 6) will use a n a dj ust me nt f or t he n u m ber of baseli ne A K lesi o ns as descri be d i n secti o n 1 0. 6. 3 . 
 
N o ot her a dj ust me nt f or c o variates is pla n ne d f or t he pri mar y a n d sec o n dar y efficac y a nal yses.  
1 0. 6. 4. 2  
H a n dli n g of Dr o p o uts or M issi n g D at a  
F or t he pri mar y a nal ysis, all s u bjects o n t he I T T p o p ulati o n wit h missi n g data f or t he pri mar y e n d p oi nt will be classifie d 
as n o n -res p o n ders re gar dless of treat me nt all ocati o n. 
 
F or  t he  se nsiti vit y  a nal ysis  of  t he  pri mar y  e n d p oi nt  a n d  f or  t he  a nal ysis  of perce nt  re d ucti o n  fr o m  baseli ne i n  t he 
n u m ber of tr eate d A K lesi o ns, missi n g data will be i m p ute d usi n g MI ( M ulti ple I m p utati o n) u n der t he Missi n g At 
Ra n d o m ( M A R) ass u m pti o n. T he f oll o wi n g ste ps will be f oll o we d:  
1.  
F or A K lesi o n c o u nt, t he missi n g ness patter n i n t he data will be e val uate d. If t he patter n is n ot m o n ot o ne, t he 
M C M C met h o d of S A S P R O C  MI will be use d t o ma ke it m o n ot o ne. T he si n gle c hai n met h o d wil l be use d, 
wit h 2 0 0 b ur n -i n iterati o ns a n d 1 0 0 iterati o ns bet wee n i m p utati o ns. T he mi ni m u m a n d ma xi m u m val ues f or 
i m p ute d varia bles will be set t o 0 an d 1 2 res pecti vel y , i n or der t o f orce P R O C MI t o re dra w a n ot her val ue f or 
i m p utati o n w he n a n i nte n de d i m p ute d val ue is less t ha n t he 0 or greater t ha n 1 2 . I m p ute d val ues will be r o u n de d 
t o t he nearest i nte ger. T he see d n u m ber will be set t o 1 1 2 1 9 9 a n d fift y ( 5 0) i m p utati o ns will be create d.  
2.  
S A S P R O C MI will be use d f or i m p uti n g missi n g val ues of data wit h m o n ot o ne missi n g patter n. If t he M C M C 
met h o d of ste p 1 was pre vi o usl y e m pl o ye d, o ne i m p utati o n will be ma de usi n g eac h of t he fift y ( 5 0) M C M C -
i m p ute d datasets. If t he M C M C met h o d of ste p 1 was n ot pre vi o usl y e m pl o ye d, fift y ( 5 0) i m p utati o ns will be 
create d ass u mi n g t he data are Missi n g At Ra n d o m. T he see d n u m ber will be set t o 1 1 2 1 9 9. T hese i m p utati o ns 
will use t he f oll o wi n g m o dels:  
a. 
F or  bi nar y  o utc o me,  a  l o gistic  re gressi o n  m o del  will  be  use d  wit h  c o variates  f or  treat me nt  a n d  n o n-
missi n g A K lesi o n c o u nt  fr o m earlier sc he d ule d ti me p oi nts i ncl u di n g baseli ne. 
b.  
F or  A K  lesi o n  c o u nt,  a  li near  re gressi o n  m o del  will  be  use d  wit h  c o variates  f o r  treat me nt  a n d  n o n-
m issi n g A K  lesi o n  c o u nt  fr o m  earlier  sc he d ule d  ti me  p oi nts  i ncl u di n g  baseli ne. T he  mi ni m u m  a n d 
ma xi m u m  val ues f or i m p ute d varia bles will be set t o 0  a n d 1 2 res pecti vel y, i n or der t o f orce P R O C MI 
t o re dra w a n ot her val ue f or i m p utati o n w he n a n i nte n de d i m p ute d val ue is less t ha n t he 0  or greater t ha n 
1 2 . I m p ute d val ues will be r o u n de d t o t he nearest i nte ger. 
3.  
T he i m p ute d datasets will be a nal yze d as s pecifie d i n secti o ns 1 0. 6. 1  a n d 1 0. 6. 3 . 
4.  
T he res ulti n g a nal ysis o n t he i m p ute d datasets will t he n be c o m bi ne d t o pr o d uce a si n gle set of statistics as 
f oll o ws: 
a. 
F or bi nar y o utc o me, t he res ults fr o m t he C M H a nal ysis will be c o m bi ne d usi n g t he pr oce d ure b y R u bi n 
[2 ] a n d Li et al. [ 3 ] t o pr o d uce a p o ole d C M H statistic a n d p-val ue. T he differe nces i n pr o p orti o ns a n d 
sta n dar d err ors will be c o m bi ne d usi n g t he S A S P R O C MI A N AL Y Z E. T he res ulti n g p o ole d  differe nce 
a n d  sta n dar d  err or  will  be  use d  t o  pr o d uce t he c o nfi de nce  i nter val  base d  o n  t he  lar ge -sa m ple 
a p pr o xi mati o n met h o d f or bi nar y data wit h o ut usi n g c o nti n uit y c orrecti o n. B ot h t hese met h o ds  will be 
use d as descri be d i n t he B o h da na Ratitc h, et al. " C o m bi ni n g A nal ysis Res ults fr o m M ulti pl y I m p ute d 
Cate g orical Data", 2 0 1 3, P har ma S U G Pr ocee di n gs, Pa per S P -0 3 [ 4 ]. 


 
R D. 0 6. S P R. 1 1 2 1 9 9  
 
 
Pa ge 3 2  of 4 3  
St atistic al A n al ysis Pl a n  
 
Versi o n Fi n al 2. 0, 0 6 -A P R- 2 0 2 1  
b.  
F or A K  lesi o n  c o u nt,  res ults  fr o m  t he  A N C O V A  a nal ysis  will  be  c o m bi ne d  usi n g  t he  S A S  P R O C 
MI A N A L Y Z E.  
 
T he n u m ber of fift y ( 5 0) i m p utati o ns was selecte d i n or der t o pre ve nt a p o wer fall off d ue t o c h o osi n g a n u m ber of 
i m p utati o ns t o o s mall [5 ]. 
 
As a d diti o nal se nsiti vit y a nal ysis of t he pri mar y e n d p oi nt, t he m ulti ple i m p utati o n pr ocess f or c o m plete res p o nse bi nar y 
o utc o me will be re peate d base d o n t he Patter n -Mi xt ure M o del u n der t he missi n g n ot at ra n d o m ( M N A R) ass u m pti o n, 
b y usi n g t he pr ofiles fr o m ve hicle D L -P D T s u bjects wit h o bser ve d data t o i m p ute missi n g da ta. T he pr ocess will be 
t he sa me descri be d f or t he M A R a nal ysis, o nl y t he ass u m pti o n a b o ut missi n g mec ha nis m will be c ha n ge d.  
 
T he m ulti ple i m p utati o n pr ocess f or c o m plete res p o nse bi nar y o utc o me will be re peate d base d o n t he Patter n -Mi xt ure 
M o del  u n der  t he  missi n g  n ot  at  ra n d o m  ( M N A R)  ass u m pti o n  i n  or der  t o  perf or m  a  ti p pi n g-p oi nt  a nal ysis f or  t he 
pri mar y e n d p oi nt b y var yi n g i n de pe n de ntl y t he ass u m pti o ns a b o ut t he missi n g o utc o mes o n t he t w o ar ms a n d i ncl u di n g 
sce nari os w here dr o p o uts o n M A L D L-P D T ar m ha v e w orse o utc o mes t ha n dr o p o uts o n Place b o  D L -P D T ar m wit h 
t he ai m of e x pl ori n g t he pla usi bilit y of missi n g data ass u m pti o ns u n der w hic h t he c o ncl usi o ns c ha n ge (i.e. u n der w hic h 
t here  is  n o  l o n ger  e vi de nce  of  efficac y).  T he  pr ocess  will  be  t he  sa me  descri bed  f or  t he  M A R  a nal ysis,  o nl y  t he 
ass u m ptio n a b o ut missi n g mec ha nis m will be c ha n ge d a n d p oi nts 2 , 3 a n d 4  will be re peate d usi n g t w o i n de pe n de nt 
se q ue nces of s hift para meters ( o ne se q ue nce f or eac h treat me nt ar m) t hat a dj ust t he im p ute d val ues f or o bser vati o ns i n 
t he t w o treat me nt ar ms u ntil t he c o m bi ne d res ults pr o vi de n o l o n ger e vi de nce of efficac y  [6 ]. T he pla usi bilit y of t he 
s hift  para meters u n der  w hic h  t he  c o ncl usi o ns  c ha n ge  a n d,  t h us,  t he  relia bilit y  of  t he  res ults  o btai ne d  u n der  M A R 
ass u m pti o n will be disc usse d.  
 
M ore o ver,  t he  pri mar y a nal ysis  will  be  re peate d  o n  t he  I T T  p o p ulati o n  b y  i m p uti n g  missi n g  data  usi n g  Last 
O bser vati o n Carrie d F or war d ( L O C F).  If n o p ost -baseli ne val ue is a vaila ble, baseli ne val ue will be carrie d f or war d.  
1 0. 6. 4. 3  
I nteri m A n al yses a n d D at a M o nit ori n g 
N o i nteri m a nal ysis is pla n ne d f or t his st u d y.  
1 0. 6. 4. 4  
M ultice nter S t u dies 
Pri or t o data base l oc k, a re vie w of t he bli n de d data will be perf or me d t o deter mi ne t he size of eac h ce nter. If t here are 
ce nters wit h a s mall n u m ber of ra n d o mize d s u bjects, t he n t hese ce nters will be  p o ole d  i n or der f or a nal yses t o be carrie d 
o ut.  T he pr ocess of c o m bi ni n g ce nters will be base d o n t he I T T p o p ulati o n, a n d sa me p o oli n g will be re peate d  f or P P 
p o p ulati o n.  
 
A s mall ce nter is defi ne d as a ce nter w hic h ra n d o mizes less t ha n 1 2 s u bjects. First , ce nters will be s orte d b y latit u de 
z o ne ( base d o n ge o gra p hic a n d cli matic si milarities) , n u m ber of ra n d o mize d s u bjects ( desce n di n g or der) a n d ce nter 
n u m ber (asce n di n g or der). P o oli n g will start wit h c o m bi ni n g t he lar gest of t he set of s mall ce nters  of a latit u de z o ne 
wit h t he s mallest ce nter wit hi n t h e sa me latit u de z o ne. If t here is a f urt her nee d t o c o m bi ne data (t he size of t he p o ole d 
ce nter s i ncl u des less t ha n 1 2 s u bjects), t he ne xt s mallest ce nter will be c o m bi ne d wit h t he ne xt lar gest of t he s mall 
ce nters, u ntil t he criteri o n of a mi ni m u m of 1 2 s u bjects is met. T he pr ocess will c o nti n ue u ntil all p o ole d ce nters ha ve 
a mi ni m u m of 1 2 s u bjects wit hi n t he sa me latit u de z o ne. A n y re mai ni n g s mall ce nters of a latit u de z o ne will be p o ole d 
wit h t he last p o ol e d ce nter wit hi n t he sa me latit u de z o ne. T he p o ole d ce nters a n d t he re mai ni n g ori gi nal u n p o ole d 
cli nical ce nters will be referre d t o as 'a nal ysis ce nters' a n d will be use d as stratificati o n fact or i n t he statistical a nal y ses. 
 
If at t he start of p o oli n g a n y latit u de z o ne has less t ha n 1 2 s u bjects i n t he  I T T p o p ulati o n i n t otal, t he n ce nters will be 
a d de d t o t he list of s mall ce nters i n a n ot her latit u de a n d t he n c o m bi ne d as a b o ve. T his decisi o n will be d oc u me nte d i n 
cli nical re p ort. 
 


 
R D. 0 6. S P R. 1 1 2 1 9 9  
 
 
Pa ge 3 3  of 4 3  
St atistic al A n al ysis Pl a n  
 
Versi o n Fi n al 2. 0, 0 6 -A P R- 2 0 2 1  
T he  c o nsiste nc y  of  t he  t reat me nt  effect  acr oss  a nal ysis  ce nters f or  t he  pri mar y  e n d p oi nt will  be  e val uate d  usi n g 
gra p hical met h o ds ( F orest pl ot).  
1 0. 6. 4. 5  
M ulti ple C o m p aris o n/ M ulti plicit y  
I n  or der  t o  mai ntai n  t he  o verall  t y pe  I  err or  rate  at  0. 0 0 1 2 5,  a  pre defi ne d  hierarc hal  testi n g  pr oce dure  will  be 
i m ple me nte d t o test t he M A L crea m a gai nst ve hicle. 
 
Testi n g will start fr o m pri mar y e n d p oi nt a n d desce n d i n t he or der descri be d as bel o w f or t he sec o n dar y e n d p oi nts u ntil 
t he n ull h y p ot hesis fails t o be rejecte d at 0. 0 0 1 2 5 le vel of si g nifica nce.  
1.  
Lesi o n  c o m plete  res p o nse,  defi ne d  as  t he  perc e nt  re d ucti o n  fr o m  baseli ne  i n  t he  n u m ber  of  cleare d  treate d 
lesi o ns, at 1 2 wee ks after t he last  D L -P D T treat me nt ( Visit 6), c o m pari n g M A L crea m wit h ve hicle crea m. 
2.  
S u bject partial res p o nse, defi ne d as t he pr o p orti o n of s u bjects wit h 7 5 % or greater re d ucti o n fr o m baseli ne i n 
t he n u m ber of cleare d treate d lesi o ns, at 1 2 wee ks after t he last D L -P D T treat me nt ( Visit 6), c o m pari n g M A L 
crea m wit h ve hicle crea m . 
1 0. 6. 4. 6  
Use of a n E ffic ac y S u bset of P ati e nts  
T he classificati o n of t he pr ot oc ol de viati o ns a n d t he e xcl usi o n of s u bjects fr o m t he P P p o p ulati o n will be deter mi ne d 
pri or t o brea ki n g t he st u d y bli n d  (see secti o n 8. 3 ). 
 
T he a nal ysis o n t he P P p o p ulati o n will all o w e val uati n g  t he i m pact of maj or pr ot oc ol de viati o ns o n t he esti mati o n of 
t he treat me nt effect. 
1 0. 6. 4. 7  
Acti ve -C o ntr ol st u dies i nte n de d t o s h o w e q ui v ale nce  
N ot a p plica ble.  
1 0. 6. 4. 8  
E x a mi n ati o n of S u b gr o u ps 
All s u b gr o u p a nal yses are e x pl orat or y i n nat ure.  
 
T o deter mi ne w het her t he treat me nt effect is c o nsiste nt acr oss vari o us s u b gr o u ps, t he esti mat e of t he bet wee n -treat me nt 
effect ( wit h n o mi nal 9 9. 8 7 5 % a n d 9 5 % CI) f or pri mar y e n d p oi nt  a n d sec o n dar y e n d p oi nts  will be prese nte d wit hi n 
eac h cate g or y of t he f ol l o wi n g classificati o n varia bles: 
•  
A K lesi o ns l ocati o n  
 
Face  
 
Bal di n g scal p  
•  
Baseli ne A K gra de  
 
Gra de 1 ( mil d) A K  
 
Gra de 2 ( m o derate) A K  
•  
Se x  
 
Male  
 
Fe male  
•  
N u m ber of baseli ne A K lesi o ns  
 
4- 8 A K lesi o ns  
 
9- 1 2 A K lesi o ns   


 
R D. 0 6. S P R. 1 1 2 1 9 9  
 
 
Pa ge 3 4  of 4 3  
St atistic al A n al ysis Pl a n  
 
Versi o n Fi n al 2. 0, 0 6 -A P R- 2 0 2 1  
•  
Fitz patric k s ki n t y pe  
 
T y pe I, II a n d III  
 
T y pe I V , V a n d VI 
 
Differe nces i n pr o p orti o ns a n d t heir n o mi nal 9 9. 8 7 5 % a n d 9 5 % c o nfi de nce i nter vals b y cate g or y f or t he classificati o n 
varia bles l iste d a b o ve will be re p orte d as well as prese nte d gra p hicall y ( F orest pl ot) o n t he I T T p o p ulati o n.  
 
Missi n g data will be i m p ute d usi n g t he sa me met h o ds f oresee n f or t he pri mar y a nal ysis of  t he pri mar y e n d p oi nt a n d 
f or t he a nal ysis of t he sec o n dar y e n d p oi nts (see secti o n 1 0. 6. 4. 2 ).  
1 0. 6. 4. 9  
A n al ysis Visit s Defi niti o n  
Efficac y, safet y a n d ot her varia bles will be s u m marize d a n d a nal yze d b y a nal ysis visit. A nal ysis visit will be sl otte d 
acc or di n g t o t he f oll o wi n g ta ble  (see Ta ble 9 ) t o s u m marize t he data b y pr o per visit. 
 
T a ble 9 - A n al ys is Visits Defi niti o n  
Cli nic al  
Visit  
A n al ysis  
Visit  
A n al ysis  
Visit  
N u m ber  
T ar get  
St u d y  
D a y  
Visit 1  
Baseli ne  
1 
1 
Visit 2  
Baseli n e 
1 
1 
Visit 2 b  
Baseli ne  
1 
1 
Visit 3  
Wee k 1  
2 
8 
Visit 4 
Wee k 2 - 4 
3 
1 5  
Visit 4 b  
Wee k 2 - 4 
3 
1 5  
Visit 5  
Wee k 3 - 5 
4 
2 2  
Visit 6  
Wee k 1 4/ Fi nal  
5 
9 9  
Earl y Ter mi nati o n  
Earl y Ter mi nati o n   
6 
--- 
 
Visit 2 b a n d Visit 4 b will occ ur o nl y i n case of i nc o m plete trea t me nt at Visit 2 a n d Visit 4 res pecti vel y. All efficac y 
assess me nts perf or me d o n Visits 2 b a n d 4 b will be ass u me d t o  fall at Visits 2 a n d 4 re gar dless of act ual ti me. 
 
Earl y ter mi nati o n visit assess me nts will be s u m marize d as a se parate visit i n all b y -vis it o ut p uts. 
 
U nsc he d ule d visits will be assi g ne d t o t he sa me a nal ysis visit of t he last sc he d ule d visit (i ncl u di n g re-treat me nt visits) 
t hat occ urre d bef ore t he u nsc he d ule d visits. 
 
A ll p ost-baseli ne safet y assess me nts will be use d f or p ote ntiall y cli nical l y si g nifica nt val ue ( P C S V) deter mi nati o ns.  
 
F or efficac y a n d safet y e n d p oi nts, if t w o or m ore assess me nts (i ncl u de b ot h sc he d ule d a n d u nsc he d ule d assess me nts) 
are  a vaila ble  f or  t he  a nal ysis  visits  t he n  all  assess me nts  will  be  liste d  a n d  t he  f oll o wi n g  r ul es  will  be  a p plie d  f or 
deter mi ni n g t he val ues t o be use d f or t he s u m mar y a n d a nal yses.  
 
F or efficac y e n d p oi nts:  


 
R D. 0 6. S P R. 1 1 2 1 9 9  
 
 
Pa ge 3 5  of 4 3  
St atistic al A n al ysis Pl a n  
 
Versi o n Fi n al 2. 0, 0 6 -A P R- 2 0 2 1  
•  
Baseli ne A nal ysis Visit: i n prese nce of m ulti ple assess me nts, t he last assess me nt perf or me d bef ore t he first D L-
P D T treat me nt (re gar dless of tre at me nt c o m pleti o n stat us) will be use d f or t he s u m maries a n d a nal yses. 
•  
Wee k 2 -4 A nal ysis Visit: i n presence of m ulti ple assess me nts , t he first assess me nt perf or me d after t he first D L-
P D T will be use d f or t he s u m maries a n d a nal yses. 
•  
Wee k  1 4/ Fi nal  A nal ysis  V isit  ( w here  a p plica ble): i n  prese nce  of  m ulti ple  assess me nts, t he  first  assess me nt 
perf or me d after t he last D L -P D T will be use d f or t he s u m maries a n d a nal yses. 
 
F or safet y assess me nts: 
•  
Cli nical La b orat or y E val uati o n: i n prese nce of m ulti ple assess me nts o n a n a nal ysis visit, t he latest assess me nt 
will be use d f or t he s u m maries a n d a nal yses.  
•  
Vital  Si g ns, E C G,  P h ysical  E xa mi nati o n:  i n  prese nce  of  m ulti ple  assess me nts  o n  a n  a nal ysis  visit,  t he 
assess me nt cl osest t o t he tar get visit date will be use d f or t he s u mmar ies a n d a nal yses.  
•  
Pai n Assess me nt:  i n prese nce of m ulti ple assess me nts o n a n a nal ysis visit, t he w orst assess me nt (i.e. t he o ne 
wit h t he hi g her N R S sc ore ) will be use d f or t he s u m mar ies a n d a nal yses.  
 
F or ot her  assess me nts:  
•  
Satisfacti o n  Q uesti o n naire: i n  prese nce  of  m ulti ple  assess me nts  o n  a n  a nal ysis  visit, t he  first  assess me nt 
perf or me d after t he last  D L -P D T will be use d f or t he s u m mar ies a n d a nal yses. 
1 0. 7  
S afet y A n al ysis 
N o f or mal i nfere ntial a nal ysis is pla n ne d f or t he baseli ne a n d safet y data, a n d o nl y  s u m mar y statistics will be pr o vi de d. 
 
S u bject Assess m e nt o f P ai n 
Pai n data will be s u m marize d b y treat me nt gr o u p usi n g sta n dar d descri pti ve statistics ( n, mea n, sta n dar d de viati o n, 
me dia n, first a n d t hir d q uartile, mi n, ma x)  a n d usi n g fre q ue nc y a n d perce nt a ge ( n, %) f or eac h N R S sc ore . Missi n g 
pai n  data  will  n ot be  i m p ute d.  T he  H o d ges -Le h ma n n  esti mat or  of  t he  me dia n  differe nce  i n  pai n  sc ores  bet wee n 
treat me nt gr o u ps a n d t he relate d 9 5 % M oses distri b uti o n-free c o nfi de nce i nter val will prese nte d b y visit f or descri pti ve 
p ur p oses o nl y.   
 
E xte nt of E x p os ure 
T he n u m ber of c o m plete a n d i nc o m plete treat me nts  per s u bject  a n d t he n u m ber of c o m plete treat me nts per s u bject will 
be s u m marize d usi n g descri pti ve statistics  ( n, mea n, sta n dar d de viati o n, me dia n, first a n d t hir d q uartile, mi n a n d ma x)  
b y treat me nt gr o u p a n d o verall.  
 
All treat me nt a p plicati o ns data will be liste d.  
 
A d verse E ve nts  A n al ysis 
All A d verse E ve nts ( A Es) will be c o de d usi n g Me d D R A dicti o nar y  ( versi o n 2 2. 0). 
 
A treat me nt -e mer ge nt a d verse e ve nt  ( T E A E) is defi ne d as a n a d verse e ve nt t hat occ urre d, or w or se ne d, o n or after t he 
date of t he first a p plicati o n of st u d y dr u g.  
 


 
R D. 0 6. S P R. 1 1 2 1 9 9  
 
 
Pa ge 3 6  of 4 3  
St atistic al A n al ysis Pl a n  
 
Versi o n Fi n al 2. 0, 0 6 -A P R- 2 0 2 1  
All treat me nt-e mer ge nt a d verse e ve nt s will be liste d i n a b y -s u bject listi n g w hic h will i ncl u de b ot h t he ter m re p orte d 
o n t he e C R F ( ver ba ti m ter m) a n d t he Me d D R A S yste m Or ga n Class a n d Pr eferre d Ter m . Relati ve start a n d st o p da ys 
will be i ncl u de d al o n g wit h t he act ual o nset a n d res ol uti o n dates. Pre -treat me nt A Es will be liste d se paratel y. 
 
If relati o ns hi p t o st u d y dr u g/ pr oce d ures is missi ng t he cl osest relati o ns hi p, i.e. “ Relate d” , will be i m p ute d. If se verit y 
is missi n g t he greatest  se verit y, i.e. “ Se vere”, will be i m p ute d. 
 
A s u m mar y ta ble of T E A Es will be pr o vi de d f or eac h of t he f oll o wi n g i n t he safet y p o p ulati o n b y treat me nt gr o u p a n d 
o verall:  
•  
N u m ber a n d perce nta ge ( n, %) of s u bjects  wit h a n y T E A E a n d fre q ue nc y of T E A Es o verall a n d b y S yste m 
Or ga n Class a n d Preferre d Ter m;  
•  
N u m ber a n d perce nta ge ( n, %) of s u bjects wit h a n y T E A E a n d fre q ue nc y of T E A Es, t hat occ urre d i n > 1 %  of 
s u bjects of t he safet y p o p ulati o n, o verall a n d b y S yste m Or ga n Class a n d Preferre d Ter m ; 
•  
N u m ber a n d perce nta ge ( n, %) of s u bjects wit h a n y A E SI a n d fre q ue nc y of A E SIs o verall a n d b y S yste m Or ga n 
Class a n d Preferre d Ter m;  
•  
N u m ber a n d perce nta ge ( n, %) of s u bjects  wit h  a n y T E A E b y cl osest relati o ns hi p  t o st u d y dr u g a n d fre q ue nc y 
of T E A Es b y cl osest relati o ns hi p  t o st u d y dr u g o verall a n d b y S yste m Or ga n Class a n d Preferre d Ter m ;  
•  
N u m ber  a n d  perce nta ge  ( n,  %)  of  s u bjects  wit h  a n y  T E A E  b y  cl osest  relati o ns hi p  t o  st u d y  pr oc e d ures  a n d 
fre q ue nc y  of  T E A Es  b y  cl osest  relati o ns hi p  t o  st u d y  pr oce d ures o verall  a n d  b y  S yste m  Or ga n  Class  a n d 
Preferre d Ter m ; 
•  
N u m ber a n d perce nta ge ( n, %) of s u bjects  wit h a n y T E A E relate d t o t he st u d y dr u g a n d fre q ue nc y of T E A Es 
relate d t o t he st u d y dr ug b y S yste m Or ga n Class a n d Preferre d Ter m;   
•  
N u m ber a n d perce nta ge ( n, %) of s u bjects  wit h a n y T E A E relate d t o t he st u d y pr oce d ures a n d fre q ue nc y of 
T E A Es relate d t o t he st u d y pr oce d ures b y S yste m Or ga n Class a n d Preferre d Ter m;   
•  
N u m ber a n d perce nta ge ( n, %) of s u bjects  wit h a n y T E A E b y greatest se verit y a n d fre q ue nc y of T E A Es b y 
greatest se verit y o verall a n d b y S yste m Or ga n Class a n d Preferre d Ter m; 
•  
N u m ber a n d perce nta ge ( n, %) of s u bjects  wit h a n y T E A E lea di n g t o st u d y disc o nti n uati o n a n d fre q ue nc y of 
T E A Es lea di n g t o st u d y disc o nti n uati o n  o verall a n d b y S yste m Or ga n Class a n d Preferre d T er m ; 
•  
N u m ber a n d perce nta ge ( n, %) of s u bjects wit h a n y T E A E lea di n g t o st u d y dr u g disc o nti n uati o n a n d fre q ue nc y 
of T E A Es lea di n g t o st u d y dr u g disc o nti n uati o n  o verall a n d b y S yste m Or ga n Class a n d Preferre d Ter m . 
 
T he sa me  s u m maries of T E A Es will be pr o vi de d f or t he f oll o wi n g s u b gr o u ps:  baseli ne A K gra de ( Gra de 1 A K a n d 
Gra de  2  A K),  se x  ( Male  a n d  Fe male),  n u m ber of  baseli ne  A K  lesi o ns  ( 4 -8  A K  lesi o ns  a n d  9 -1 2  A K  lesi o ns)  a n d 
Fitz patric k s ki n t y pe ( T y pe I, II a n d III a n d T y pe I V, V a n d VI) . 
 
A s u m mar y ta ble of T E A Es will be pr o vi de d  f or t he f oll o wi n g i n t he safet y p o p ulati o n b y treat me nt gr o u p a n d o verall: 
 
•  
N u m ber a n d perce nta ge ( n, %) of s u bjects wit h a n y T E A E a n d fre q ue nc y of T E A Es, t hat occ urre d i n > 5 % of 
s u bjects of t he safet y p o p ulati o n, o verall a n d b y S yste m Or ga n Class a n d Preferre d Ter m . 
 
A s u m mar y ta ble of seri o us T E A Es will be pr o vi de d f or eac h of t he f oll o wi n g i n t he safet y p o p ulati o n b y treat me nt 
gr o u p a n d o verall:  
•  
N u m ber a n d perce nta ge ( n, %) of s u bjects  wit h a n y Seri o us T E A E a n d fre q ue nc y of Seri o us T E A Es o verall 
a n d b y S yste m Or ga n Class a n d Preferre d Ter m;  
•  
N u m ber a n d perce nta ge ( n, %) of s u bjec ts wit h a n y Seri o us T E A E b y cl osest relati o ns hi p  t o st u d y dr u g a n d 
fre q ue nc y  of  Seri o us  T E A Es  b y  cl osest  relati o ns hi p  t o  st u d y  dr u g o verall  a n d  b y  S yste m  Or ga n  Class  a n d 
Preferre d Ter m ;  
•  
N u m ber a n d perce nta ge ( n, %) of s u bjects  wit h a n y Seri o us T E A E b y cl osest relati o ns hi p t o st u d y pr oce d ures 
a n d fre q ue nc y of Seri o us T E A Es b y cl osest relati o ns hi p t o st u d y pr oce d ures  o verall a n d b y S yste m Or ga n Class 
a n d Preferre d Ter m ;  


 
R D. 0 6. S P R. 1 1 2 1 9 9  
 
 
Pa ge 3 7  of 4 3  
St atistic al A n al ysis Pl a n  
 
Versi o n Fi n al 2. 0, 0 6 -A P R- 2 0 2 1  
•  
N u m ber a n d perce nta ge ( n, %) of s u bjects  wit h a n y Seri o us T E A E relate d t o t he st u d y dr u g a n d fre q ue nc y of 
Seri o us T E A Es relate d t o t he  st u d y dr u g b y S yste m O r ga n Class a n d Preferre d Ter m;  
•  
N u m ber a n d perce nta ge ( n, %) of s u bjects  wit h a n y Seri o us T E A E relate d t o t he st u d y pr oce d ures a n d fre q ue nc y 
of Seri o us T E A Es relate d t o t he st u d y pr oce d ures b y S yste m Or ga n Class a n d Preferre d Ter m;   
•  
N u m ber  a n d  perce nta ge  ( n,  %)  of  s u bjects  wit h  a n y  Seri o us  T E A E  lea di n g  t o  st u d y  disc o nti n uati o n  a n d 
fre q ue nc y of Seri o us T E A Es lea di n g t o st u d y disc o nti n uati o n o verall a n d b y S yste m Or ga n Class a n d Preferre d 
Ter m ; 
•  
N u m ber a n d perce nta ge ( n, %) of s u bjects wit h a n y Seri o us T E A E lea di n g t o st u d y dr u g disc o nti n uati o n a n d 
fre q ue nc y of  Seri o us  T E A Es lea di n g  t o  st u d y dr u g  disc o nti n uati o n  o verall  a n d  b y  S yste m  Or ga n  Class  a n d 
Preferre d Ter m ; 
•  
N u m ber a n d perce nta ge ( n, %) of s u bjects  wit h a n y Seri o us T E A E lea di n g t o deat h a n d fre q ue nc y of Seri o us 
T E A Es lea di n g t o deat h  o verall a n d b y S yste m Or ga n Class a n d Preferre d Ter m . 
 
I n or der t o e val uate t he i m pact of C O VI D-1 9 o n t he safet y of t he s u bjects, a  s u m mar y ta ble of T E A Es a n d seri o us 
T E A Es will be pr o vi de d f or eac h of t he f oll o wi n g f or t he s afet y p o p ulati o n b y treat me nt gr o u p a n d o verall:  
 
•  
N u m ber  a n d  perce nta ge  ( n,  %)  of  s u bjects  wit h  a n y  T E A E  relate d  t o C O VI D -1 9  a n d  fre q ue nc y  of  T E A Es 
relate d t o C O VI D -1 9  b y S yste m Or ga n Class a n d Preferre d Ter m . 
•  
N u m ber  a n d  perce nta ge  ( n,  %)  of  s u bjects  wit h  a n y  Se ri o us  T E A E  relate d  t o  C O VI D-1 9  a n d  fre q ue nc y  of 
Seri o us T E A Es relate d t o C O VI D -1 9 b y S yste m Or ga n Class a n d Preferre d Ter m . 
 
Listi n gs of all A Es lea di n g t o deat h, all seri o us A Es , all T E A Es lea di n g t o st u d y disc o nti n uati o n , all A E SIs a n d all 
A Es d ue t o C O VI D-1 9 will be  pr o vi de d.  
 
P h ysic al E x a mi n ati o n A n al ysis 
P h ysical  e xa mi nati o n  assess m e nts  will  be  s u m marize d  i n  ter ms  of n u m ber  a n d  perce nta ge  ( n,  %)  of  s u bjects  wit h 
' Nor mal', ' A b n o r mal/N ot C li ni call y S i g nifica nt' a n d ' Ab n or mal / Cli nicall y S i g nifica nt' res ults f or eac h b o d y s yste m. 
 
S u m maries will be prese nte d b y treat me nt gr o u p a n d o verall at baseli ne  a n d visit 6 / E T. 
 
A listi n g of all p h ysical e xa mi nati o n assess me nts will be pr o vi de d.  
 
Vit al Si g ns  A n al ysis 
Descri pti ve statistics  ( n, mea n, sta n dar d de viati o n, me dia n, first a n d t hir d q uartile, mi n a n d ma x)  b y treat me nt gr o u p 
a n d o verall will be prese nte d f or vital si g ns at baseli ne  a n d visit 6 / E T a n d f or t heir c ha n ge fr o m baseli n e t o visit 6 / E T. 
 
N u m ber  a n d  perce nta ge  ( n,  %)  of  s u bjects  wit h  Cli nicall y  Si g n ifica nt  Ab n or mal V al ues (as  i de ntifie d  b y  t he 
I n vesti gat or) a n d wit h P ote ntiall y Cli nicall y Si g nifica nt Val ues  (see secti o n 1 3. 2 ) will be s u m marize d b y treat me nt 
gr o u p a n d o verall at baseli ne  a n d visit 6 / E T. 
 
A listi n g of all vital si g ns will be pr o vi de d. 
 
Cli nic al L a b or at or y Tests A n al ysis 
Descri pti ve statistics  ( n, mean, sta n dar d de viati o n, me dia n, first a n d t hir d q uartile, mi n a n d ma x)  b y treat me nt gr o u p 
a n d o verall will be prese nte d f or bl o o d c he mistr y, he mat o l o g y a n d q ua ntitati ve uri nal ysis para meters at baseli ne  a n d 
visit 6 / E T a n d f or t heir c ha n ge fr o m baseli ne  t o visit 6 / E T. 
 


 
R D. 0 6. S P R. 1 1 2 1 9 9  
 
 
Pa ge 3 8  of 4 3  
St atistic al A n al ysis Pl a n  
 
Versi o n Fi n al 2. 0, 0 6 -A P R- 2 0 2 1  
F or s u m mar y p ur p oses, la b orat or y val ues t hat are liste d as a b o ve or bel o w partic ular t hres h ol ds will be n u meric all y 
i m p ute d as a b o ve or bel o w t hat t hres h ol d, res pecti vel y, b y t he mi ni m u m meas ure d a m o u nt f or t hat para meter. F or 
e xa m ple, if a para meter is meas ure d t o t w o deci mal places, a n d has a res ult of “ > 5” t he n, f or s u m mar y p ur p oses, t he 
val ue of 5. 0 1 will be u se d. 
 
N u m ber  a n d  perce nta ge  ( n,  %)  of  s u bjects  f or  eac h  res p o nse  cate g or y  of  q ualitati ve  uri nal ysis  para meter  will  be 
prese nte d b y treat me nt gr o u p a n d o verall at baseli ne  a n d visit 6 / E T. 
 
N u m ber a n d perce nta ge ( n, %) of s u bjects wit h la b orat or y test val ues bel o w, wit hi n a n d a b o v e t he la b orat or y refere nce 
ra n ges will be s u m marize d b y treat me nt gr o u p a n d o verall at baseli ne  a n d visit 6 / E T. 
 
N u m ber  a n d  perce nta ge  ( n,  %)  of  s u bjects  wit h  Cli nicall y  Si g nifica nt  A b n or mal  Val ues  (as  i de ntifie d  b y  t he 
I n vesti gat or) a n d wit h P ote ntiall y Cli nicall y Si g nifica nt Val ues (see secti o n 1 3. 3 ) will be s u m marize d b y treat me nt 
gr o u p a n d o verall at baseli ne  a n d visit 6 / E T. 
 
S hift ta bles fr o m baseli ne  t o visit 6 / E T descri bi n g s hifts t o a b n or malit y will be pr o vi de d as well. O nl y s u bjects wit h a 
baseli ne  res ult a n d a res ult at visit 6/ E T f or t he para meter will be c o nsi dere d.  
 
A listi n g of all cli nical la b orat or y test will be pr o vi de d.  
 
Electr oc a r di o gr a ms A n al ysis  
T he n u m ber a n d perce nta ge ( n, %) of s u bjects  w h o ha ve In vesti gat or’s i nter pretati o n of E C G  ' Nor mal', ' A b n or mal/ N ot 
C li nicall y S i g nifica nt'  a n d  'A b n or mal/ C li nicall y S i g nifica nt' will  be  prese nte d  b y  treat me nt  gr o u p  a n d o verall  at 
baseli ne  a n d visit 6 / E T. 
 
A listi n g of I n vesti gat or’s i nter pretati o n of E C G res ults a n d a listi n g of E R T E C G res ults  will be pr o vi de d.  
 
S afet y Visit Q uesti o n  
T he a ns wers Yes/ N o t o t he q uesti o n " D oes t he s u bject e x hi bit si g ns a n d s y m pt o ms of p ossi ble c o ntact se nsitizati o n?" 
at Visit 3 a n d Visit 5 will be liste d.  
1 0. 8  
Ot her Assess m e nts A n al ysis 
 
S atisf acti o n Q uesti o n n aires  A n al ysis 
N u m ber a n d perce nta ge ( n, %) of s u bjects  f or eac h a ns wer of eac h q uesti o n of t he satisfacti o n q uesti o n naires  will be 
prese nte d b y treat me nt gr o u p a n d o verall at visit 4 (4 b if a p plica ble, sec o n d D L -P D T) a n d visit  6/ E T. 
 
A listi n g of all satisfacti o n q uesti o n naires data will be pr o vi de d.  
 
We at her Ass ess m e nt  
A listi n g of all weat her  assess me nt data will be pr o vi de d . 


 
R D. 0 6. S P R. 1 1 2 1 9 9  
 
 
Pa ge 3 9  of 4 3  
St atistic al A n al ysis Pl a n  
 
Versi o n Fi n al 2. 0, 0 6 -A P R- 2 0 2 1  
 
S u bject's S ki n As pect A n al ysis  
Sc ores of cli nical assess me nt of s u bject's s ki n as pect c ollecte d at Vis it 6/ E T will be s u m marize d b y treat me nt gr o u p 
a n d o verall b y re p orti n g t he n u m ber a n d perce nta ge of s u bjects ( n, %) f or eac h sc ore. F or t he ai m of s u m mar y, t he 
w orst sc ore a m o n g all t he assesse d lesi o ns of eac h s u bject will be ta ke n i nt o acc o u nt.  
 
S u bject E x p os ure Ti m e a n d P pI X Effecti ve D ose  A n al ysis 
Descri pti ve statistics ( n, mea n, sta n dar d de viati o n, me dia n, first a n d  t hir d q uartile, mi n a n d ma x) b y treat me nt gr o u p 
a n d o verall will be prese nte d f or s u bject e x p os ure ti me a n d P pI X effecti ve d ose at v isit 2 ( 2 b, if a p plica ble) a n d v isit 
4 (4 b , if a p plica ble). 
 
A listi n g of all s u bject e x p os ure ti mes a n d P pI X effecti ve d oses will be pr o vi de d. 
 
S us pecte d Se nsitiz ati o n ( Rec h alle n ge a n d P atc h I n gre die nt Test)  
Rec halle n ge patc h test a n d i n gre die nt patc h test i nf or m ati o n will be prese nte d i n se parate listi n g.  
1 1  
C H A N G E S F R O M T H E P R O T O C O L A N A L Y SI S P L A N  
A n y c ha n ge fr o m t he pr ot oc ol will be j ustifie d a n d f ull y d oc u me nte d.  
 
If t he bli n d re vie w s u g gests c ha n ges t o t he pri nci pal feat ures state d i n t he pr ot oc ol, t hese ha ve t o be d oc u me nte d i n a 
pr ot oc ol a me n d me nt. Ot her wise, it will s uffice t o u p date t he statistical a nal ysis pl a n wit h t he c o nsi derati o ns s u g geste d 
fr o m t he bli n d re vie w. 


 
R D. 0 6. S P R. 1 1 2 1 9 9  
 
 
Pa ge 4 0  of 4 3  
St atistic al A n al ysis Pl a n  
 
Versi o n Fi n al 2. 0, 0 6 -A P R- 2 0 2 1  
1 2  
S H E L L S O F  T A B L E S,  FI G U R E S  A N D  LI S TI N G S  A N D  R E P O R TI N G 
O U T P U T ( G E N E R A L F E A T U R E S)  
Ta bles,  fi g ure s  a n d  listi n gs  will  be  ge nerate d  usi n g  S A S ®  a n d  will  be  dis pla ye d  o n  A 4  size  pa per  wit h  la n dsca pe 
o rie ntati o n, 2 c m f or t o p a n d b ott o m  mar gi ns , 0. 8 c m f or left a n d ri g ht mar gi n s a n d 8 pt C o urier Ne w f o nt.  
 
T he hea der secti o n will c o m prise t he s p o ns or’s na me, t he pr ot oc ol n u m ber, t he deli ver y descri pti o n, t he T F L n u m ber, 
t he T F L title, t he p o p ulati o n a n d t he pa ge n u m ber ( Pa ge X of Y). T he f o oter secti o n will i ncl u de t he T F L f o ot n otes , 
t he data e xtract date (if a p plica ble) , t he date a n d ti me of t he e xec uti o n of t he pr o gra m, a n d t he na me of t he pr o gra m. 
 
A clear, acc urate a n d c o m plete pr o gra m mi n g c o de will be de vel o pe d t o ge nerate t he statistical a nal yses, s u m mar y 
ta bles, fi g ures a n d listi n gs t o be i nte grate d i n  t he re p ort. Fl ue nt use of precise titles a n d f o ot n otes will be ma de t o 
i m pr o ve t he u n dersta n di n g of s u m maries a n d d oc u me nt a n y ass u m pti o n. Details of a nal ysis s pecificati o ns i ncl u di n g 
b ut n ot li mite d t o t he S A S c o de will be d oc u me nte d o n t he s hells.  


 
R D. 0 6. S P R. 1 1 2 1 9 9  
 
 
Pa ge 4 1  of 4 3  
St atistic al A n al ysis Pl a n  
 
Versi o n Fi n al 2. 0, 0 6 -A P R- 2 0 2 1  
1 3  
A P P E N DI C E S  
1 3. 1  
S hells f or T a ble, Fi g ure a n d Listi n gs 
T he fi n al list of ta bles, fi g ures a n d listi n gs a n d t heir s hells f or t he re p orti n g of t his s t u d y will be a vaila ble i n a se parate 
d oc u me nt t hat will be de vel o pe d a n d will be fi nalize d bef ore data base l oc k.  
1 3. 2  
P ote nti all y Cli nic all y Si g nific a nt V al ues of Vit al Si g ns  
Criteria f or i de ntif yi n g vital si g ns val ues as P ote ntiall y Cli nicall y Si g nifica nt Val u es are t he f oll o wi n g.  
 
T a ble 1 0  - P ote nti all y Cli nic all y Si g nific a nt V al ues of Vit al Si g ns  
P ar a m eter  
Criteri a  
 
C h a n ge Rel ati ve t o B aseli ne  
P ulse  Rate  
≥ 1 2 0 beats/ mi n  
a n d a n 
i ncrease ≥ 2 0  beats/ mi n  
 
≤ 5 0 beats/ mi n  
a n d a 
decrease ≥ 2 0  beats/ mi n  
S yst olic Bl o o d Press ure  
≥ 1 6 0 m m H g  
a n d a n 
i ncrease ≥ 2 0 m m H g 
 
≤ 9 5  m m H g  
a n d a 
decrease ≥ 2 0 m m H g  
Diast olic Bl o o d Press ure  
≥ 1 1 0  m m H g  
a n d a n 
i ncrease ≥ 10  m m H g  
 
≤ 4 5  m m H g  
a n d a 
decrease ≥ 1 0  m m H g  
B o d y Te m perat ure  
≥ 3 8. 3 o C  
a n d an  
i ncrease ≥ 1. 1 o C  
 
≥ 1 0 1 o F  
a n d an  
i ncrease ≥ 2 o F  
1 3. 3  
P ote nti all y Cli nic all y Si g nific a nt V al ues of L a b or at or y Tests 
Criteria f or i de ntif yi n g la b orat or y test val ues as P ote ntiall y Cli nicall y Si g nifica nt Val ues are t he f oll o wi n g.  
 
T a ble 1 1  - P ote nti all y Cli nic all y Si g nific a nt V al ues of L a b or at or y Tests  
P ar a m eter  
Se x  
Criteri o n V al ues  
 
 
 
St a n d ar d U nits  
SI U nits  
Bl o o d C he mistr y  
 
 
 
As partate A mi n otra nsferase  
Male a n d  Fe male  
> 3 x U L N  
> 3 x U L N  
Ala ni ne A mi n otra nsferase  
Male a n d Fe male  
> 3 x U L N  
> 3 x U L N  
Al kali ne P h os p hatase  
Male a n d Fe male  
> 4 0 0 U/ L  
> 4 0 0 U/ L  
Ga m ma Gl uta m yltra nsferase  
Male a n d Fe male  
> 3 x U L N  
> 3 x U L N  
Lactate De h y dr o ge nase  
Male a n d Fe male  
> 3 x U L N  
> 3 x U L N  
Urea  
Male a n d Fe male  
>  6 4  m g/ d L  
>  1 0. 7 m m ol/ L  
Bl o o d Urea Nitr o ge n  
Male a n d Fe male  
> 2 9. 9  m g/ d L  
> 1 0. 7 m m ol/ L  
Creati ni ne  
Male a n d Fe male  
>  2. 0 m g/ d L  
>  1 7 6. 8 µ m ol/ L  


 
R D. 0 6. S P R. 1 1 2 1 9 9  
 
 
Pa ge 4 2  of 4 3  
St atistic al A n al ysis Pl a n  
 
Versi o n Fi n al 2. 0, 0 6 -A P R- 2 0 2 1  
P ar a m eter  
Se x  
Criteri o n V al ues  
 
 
 
St a n d ar d U nits  
SI U nits  
Creati ni ne K i nase 
Male a n d Fe male  
>  2. 5 x U L N  
> 2. 5 x U L N  
Uric Aci d  
Male  
>  1 0. 0  m g/ d L  
>  0. 5 9 4 8  m m ol / L 
 
Fe male  
>  8. 0  m g/ d L  
>  0. 4 7 5 8  m m ol / L 
T otal Bilir u bi n  
Male a n d Fe male  
>  2. 0 m g/ d L  
>  3 4. 2 µ m ol/ L  
Al b u mi n  
Male a n d Fe male  
< 2 5  g/ L  
< 3. 6 3  µ m ol/ L  
S o di u m  
Male a n d Fe male  
< 1 3 0 m m ol/ L  
< 1 3 0 m m ol/ L  
 
 
> 1 5 0 m m ol/ L  
> 1 5 0 m m ol/ L  
P ot assi u m  
Male a n d Fe male  
< 3. 0 m m ol/ L  
< 3. 0 m m ol/ L  
 
 
> 5. 5  m m ol/ L  
> 5. 5  m m ol/ L  
Calci u m  
Male a n d Fe male  
< 7 m g/ d L  
< 1. 7 5 m m ol/ L  
 
 
> 1 2 m g/ d L  
>  3. 0 0 m m ol/ L  
C hl ori de  
Male a n d Fe male  
< 9 0 m m ol/ L  
< 9 0 m m ol/ L  
 
 
> 1 1 8 m m ol/ L  
> 1 1 8 m m ol/ L  
Gl uc ose  
Male a n d Fe m ale 
< 5 0 m g/ d L  
< 2. 7 8 m m ol/ L  
 
 
> 2 5 0 m g/ d L  
> 1 3. 8 8 m m ol/ L  
T otal C h olester ol  
Male a n d Fe male  
> 3 0 0 m g/ d L  
> 7. 7 7 m m ol/ L  
L o w -De nsit y Li p o pr otei n  
Male a n d Fe male  
> 1 6 0 m g/ d L  
> 4. 1 4 m m ol/ L  
Hi g h -De nsit y Li p o pr otei n  
Male a n d Fe male  
< 3 0 m g/ d L  
< 0. 7 8 m m ol/ L  
T ri gl yceri des 
Male a n d Fe male  
> 3 0 0 m g/ d L  
> 3. 3 9 m m ol/ L  
He m at ol o g y  
 
 
 
He mat ocrit  
Male  
≤ 3 7 %  
≤ 0. 3 7  L/ L  
 
Fe male  
≤ 3 2 %  
≤ 0. 3 2  L/ L  
He m o gl o bi n  
Male  
≤ 1 1. 5 g/ d L  
≤ 1 1 5 g/ L  
 
Fe male  
≤ 9. 5 g/ d L  
≤ 9 5 g/ L  
Platelets  
Male a n d Fe male  
≤ 7 5 1 0 3/ µ L 
≤ 7 5 1 0 9/ L 
 
 
≥ 7 0 0  1 0 3/ µ L 
≥ 7 0 0 1 0 9/ L 
Le u k oc ytes  
Male a n d Fe male  
≤ 2 .8 1 0 3/ µ L 
≤ 2. 8 1 0 9/ L 
 
 
≥ 1 6 1 0 3/ µ L 
≥ 1 6 1 0 9/ L 
E osi n o p hils  
Male a n d Fe male  
> 1. 0 1 0 3/ µ L 
> 1. 0 1 0 9/ L 
Ne utr o p hils  
Male a n d Fe male  
<  1. 5 1 0 3/ µ L 
<  1. 5 1 0 9/ L 
 


 
R D. 0 6. S P R. 1 1 2 1 9 9  
 
 
Pa ge 4 3  of 4 3  
St atistic al A n al ysis Pl a n  
 
Versi o n Fi n al 2. 0, 0 6 -A P R- 2 0 2 1  
1 4  
R E F E R E N C E S  
1.  
H ui pi n g Z ha n g , " Pr o p orti o n differe nce a n d c o nfi de nce i nter val base d o n C oc hra n -Ma ntel -Hae nszel met h o d i n 
stratifie d m ulti-ce nter cli nical trial" , P har ma S U G C hi na 2 0 1 6, Pa per 2 5 
2.  
R u bi n D. B. 1 9 8 7, " M ulti ple I m p utati o n f or N o nres p o nse i n S ur ve ys", Ne w Y or k: J o h n Wile y a n d S o ns.  
3.  
Li, K. -H., M e n g, X. -L., Ra g h u nat ha n, T. E., a n d R u bi n, D. B. 1 9 9 1, " Si g nifica nce le vels fr o m re peate d p -val ues 
wit h m ulti pl y -i m p ute d data", Statistica Si nica, 1( 1), 6 5-9 2.  
4.  
B o h da na  Ratitc h,  et  al.  " C o m bi ni n g  A nal ysis  Res ults  fr o m  M ulti pl y  I m p ute d  Cate g orical  Data",  2 0 1 3,  
P har ma S U G Pr ocee di n gs, Pa per S P -0 3.  
5.  
J o h n  W.  Gra ha m,  Allis o n  E. Olc h o ws ki,  Ta mi ka  D.  Gilreat h,  " H o w  Ma n y  I m p utati o ns are  Reall y  Nee de d? 
S o me  Practical  Clarificati o ns  of  M ulti ple  I m p utati o n  T he or y",  Pre v  Sci  ( 2 0 0 7)  8: 2 0 6 – 2 1 3  D OI 
1 0. 1 0 0 7/s 1 1 1 2 1 -0 0 7 -0 0 7 0 - 9 
6.  
Ya n g Y ua n, " Se nsiti vit y A nal ysis i n M ulti ple I m p utati o n f or Missi n g Data", S A S I nstit ute I nc., Pa per S A S 2 7 0 -
2 0 1 4