A Randomized, Open-Label, Clinical Study to Evaluate a Methodology to Assess Food Occlusion Efficacy of a Denture Adhesive in Healthy, Edentulous Subjects
Phase: NA
Conditions: Denture Retention
Sponsor: GlaxoSmithKline

S o di u m -calci u m mi xe d partial salt of p ol y( met h yl vi n y let her/ maleic aci d) a n d 
car b o x y met h ylcell ul ose
2 0 8 3 9 7
Fi nal Cli nical Pr ot oc ol, 2 0 Oct 2 0 1 7
Pr o pert y  of G S K C o ns u mer Healt hcare
C o nfi de ntial
Ma y  n ot be use d, di v ul ge d, p u blis he d or ot her wise discl ose d
wit h o ut t he c o nse nt of G S K
Te m plate Versi o n Effecti ve: 2 2 -J u n-2 0 1 7
Pa ge 1 of 6 2
C LI NI C A L P R O T O C O L
A R a n d o mi s e d, O p e n -L a b el, Cli ni c al St u d y t o E v al u at e a 
M et h o d ol o g y t o A s s e s s F o o d O c cl u si o n Effi c a c y of a D e nt ur e 
A d h e si v e i n H e alt h y, E d e nt ul o u s S u bj e ct s.
C o m p o u n d N a m e:  
S o di u m -c al ci u m mi x e d p arti al s alt of 
p ol y( m et h yl vi n yl et h er/ m al ei c a ci d) a n d 
c ar b o x y m et h yl c ell ul o s e
U nit e d St at e s ( U S) I n v e sti g ati o n al 
N e w Dr u g (I N D) N u m b er:
N/ A
E ur o p e a n Cli ni c al Tri al s D at a b a s e 
( E u dr a C T) N u m b er:
N/ A
Ot h er R e g ul at or y A g e n c y I d e ntifi e d 
N u m b er:
N/ A
Pr ot o c ol N u m b er:
2 0 8 3 9 7
P h a s e:
II
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
2 4- O ct- 2 0 1 7 0 8: 4 9: 0 5
 
2 0 8 3 9 7 Cli ni c al Pr ot o c ol 2. d o c x
el d o _ c o ntr oll e d
2. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d b 1 b 9 1
Pa ge 1 of 6 2

S o di u m -calci u m mi xe d partial salt of p ol y( met h yl vi n y let her/ maleic aci d) a n d car b o x y met h ylcell ul ose
2 0 8 3 9 7
Fi nal Cli nica l Pr ot oc ol, 2 0 Oct 2 0 1 7
Gla x o S mit h Kli ne C o ns u mer Healt hcare C o nfi de ntial
Te m plate Ver si o n Effecti ve: 2 2-J u n-2 0 1 7
Pa ge 2 of  6 2
S p o n s or i nf or m ati o n
S p o ns or Le g al Re gistere d A d dress
Gl a x o S mit h Kli ne Rese arc h & De vel o p me nt 
Li mite d
9 8 0 Great West R oa d
Br e ntf or d
Mi d dlese x, T W 8 9 G S
U K
S p o ns or C o nt act A d dress
Gla x o S mit h Kli ne C o ns u mer Healt hcare ( G S K C H)
1 8 4 Li bert y C or ner R oa d,
Warre n, NJ, 0 7 0 5 9
Tel: 
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
2 4- O ct- 2 0 1 7 0 8: 4 9: 0 5
 
2 0 8 3 9 7 Cli ni c al Pr ot o c ol 2. d o c x
el d o _ c o ntr oll e d
2. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d b 1 b 9 1
Pa ge 2 of 6 2
P P D

S o di u m -calci u m mi xe d partial salt of p ol y( met h yl vi n y let her/ maleic aci d) a n d car b o x y met h ylcell ul ose
2 0 8 3 9 7
Fi nal Cli nica l Pr ot oc ol, 2 0 Oct 2 0 1 7
Gla x o S mit h Kli ne C o ns u mer Healt hcare C o nfi de ntial
Te m plate Ver si o n Effecti ve: 2 2-J u n-2 0 1 7
Pa ge 3 of  6 2
D o c u m e nt Hi st or y
D oc u me nt
Versi o n D ate
S u m m ar y of C h a n ges 
Ori gi nal pr ot oc ol
2 0 Oct 2 0 1 7
N ot a p plica ble ( N/ A)
A me n d me nts i nc or p orate all re visi o ns t o date, i ncl u di n g a me n d me nts ma de at t he re q uest of 
c o u ntr y healt h a ut h orities, i nstituti o nal  re vie w b oar ds/et hics c o m mittees (I R Bs/ E Cs), etc.  
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
2 4- O ct- 2 0 1 7 0 8: 4 9: 0 5
 
2 0 8 3 9 7 Cli ni c al Pr ot o c ol 2. d o c x
el d o _ c o ntr oll e d
2. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d b 1 b 9 1
Pa ge 3 of 6 2

S o di u m -calci u m mi xe d partial salt of p ol y( met h yl vi n y let her/ maleic aci d) a n d car b o x y met h ylcell ul ose
2 0 8 3 9 7
Fi nal Cli nica l Pr ot oc ol, 2 0 Oct 2 0 1 7
Gla x o S mit h Kli ne C o ns u mer Healt hcare C o nfi de ntial
Te m plate Ver si o n Effecti ve: 2 2-J u n-2 0 1 7
Pa ge 4 of  6 2
P RI N CI P A L I N V E S TI G A T O R P R O T O C O L A G R E E M E N T P A G E

I c o nfir m a gree me nt t o c on d uct t he st u d y  in c o m p lia nce with t he pr ot oc ol a n d a n y 
a me n d me nts a n d acc or di n g t o t he c urre nt I C H G C P g ui deli nes.

I ac k n o wle d ge t hat I a m res p o nsi ble f or o verall st u d y  c o n d uct. I a gree t o pers o nall y 
c o n d uct or s u per vise t he descri be d st u d y.

I a gree t o e ns ure t hat all ass ociates, c ollea g ues a n d e m pl o yees assist i n g i n t he c o n d uct of 
t he st u d y are i nf or me d a b o ut t heir o bli gati ons. Mec ha nis ms are i n place t o e ns ure site staff 
recei ves all a p pr o priate i nf or mati on t hr o u g h o ut t he st u d y .

I a gree t o c o n d uct t his st u d y in f ull c o nf or ma nce with t he l a ws a n d re g ulati o ns of t he 
c o u ntr y in w hic h t he researc h is c o n d ucte d a n d t he Declarat i on of Helsi n ki.
I n vesti gat or Na me:
Jeffre y L. Mille ma n
I n vesti gat or Q ualificati ons:
D D S, M P A
I n vesti gat or Si g nat ure:
Date of Si g nat ure/ A gree me nt:
D D/ M M M/ Y Y Y Y
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
2 4- O ct- 2 0 1 7 0 8: 4 9: 0 5
 
2 0 8 3 9 7 Cli ni c al Pr ot o c ol 2. d o c x
el d o _ c o ntr oll e d
2. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d b 1 b 9 1
Pa ge 4 of 6 2
P P D

S o di u m -calci u m mi xe d partial salt of p ol y( met h yl vi n y let her/ maleic aci d) a n d car b o x y met h ylcell ul ose
2 0 8 3 9 7
Fi nal Cli nica l Pr ot oc ol, 2 0 Oct 2 0 1 7
Gla x o S mit h Kli ne C o ns u mer Healt hcare C o nfi de ntial
Te m plate Ver si o n Effecti ve: 2 2-J u n-2 0 1 7
Pa ge 5 of  6 2
T a bl e of c o nt e nt s
S p o ns or i nf or mati o n ........................................................................................................2
D oc u m e nt Hist or y........................................................................................................... 3
P RI N CI P A L I N V E S TI G A T O R P R O T O C O L A G R E E M E N T P A G E ..............................4
Ta ble of c o nte nts .............................................................................................................5
List of ta bles ...................................................................................................................9
S C H E D U L E O F A C TI VI TI E S .....................................................................................1 0
1
I N T R O D U C TI O N ........................................................................................................1 1
1. 1
Mec ha nis m of Act i on/I n dicat i on ........................................................................1 2
1. 2
Bac k gr o u n d a n d Rat i onale .................................................................................1 2
1. 2. 1
St u d y  Desi g n Rati onale ......................................................................1 2
1. 2. 2
Treat me nts .........................................................................................1 4
2
S T U D Y O BJ E C TI V E S A N D E N D P OI N T S ................................................................. 1 5
3
S T U D Y D E SI G N A N D S U BJ E C T P O P U L A TI O N ......................................................1 6
4
S U BJ E C T S E L E C TI O N ...............................................................................................1 7
4. 1
I ncl usi on Cri t eria ...............................................................................................1 7
4. 2
E xcl usi o n Cri t eria ..............................................................................................1 8
4. 3
Ra n d o misat i on Cri t eria ......................................................................................1 9
4. 4
Lifest yle G ui deli nes ...........................................................................................1 9
4. 4. 1
Meals a n d Dietar y  Restrict i ons ..........................................................1 9
4. 4. 2
C o ntrace pti o n ....................................................................................1 9
4. 5
Scree n Fail ures ..................................................................................................2 0
4. 6
S p o ns or’s Q ualifie d Me dical Pers o n nel ..............................................................2 1
5
S T U D Y T R E A T M E N T S ..............................................................................................2 1
5. 1
Bli n di n g a n d All ocat i on t o Treat m e nt/ Ra n d o misat i o n........................................2 1
5. 2
S u bject C o m plia nce ...........................................................................................2 2
5. 3
I n vesti gati onal Pr o d uct S u p plies ........................................................................2 2
5. 3. 1
D osa ge F or m a n d Pac ka gi n g ..............................................................2 3
5. 3. 2
Pre parati o n a n d Dis pe nsi n g ................................................................2 3
5. 4
A d mi nistrati o n ...................................................................................................2 3
5. 4. 1
Me dicat i on Err ors ..............................................................................2 3
5. 5
I n vesti gati onal Pr o d uct St ora ge ..........................................................................2 4
5. 6
I n vesti gati onal Pr o d uct Acc o u nta bilit y ...............................................................2 4
5. 6. 1
Destr ucti o n of I n vesti gati onal Pr o d uct S u p plies ................................. 2 5
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
2 4- O ct- 2 0 1 7 0 8: 4 9: 0 5
 
2 0 8 3 9 7 Cli ni c al Pr ot o c ol 2. d o c x
el d o _ c o ntr oll e d
2. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d b 1 b 9 1
Pa ge 5 of 6 2

S o di u m -calci u m mi xe d partial salt of p ol y( met h yl vi n y let her/ maleic aci d) a n d car b o x y met h ylcell ul ose
2 0 8 3 9 7
Fi nal Cli nica l Pr ot oc ol, 2 0 Oct 2 0 1 7
Gla x o S mit h Kli ne C o ns u mer Healt hcare C o nfi de ntial
Te m plate Ver si o n Effecti ve: 2 2-J u n-2 0 1 7
Pa ge 6 of  6 2
5. 7
C o nc o mita nt Treat me nts ....................................................................................2 5
5. 8
Resc ue Me dicat i on .............................................................................................2 5
6
S T U D Y P R O C E D U R E S ...............................................................................................2 6
6. 1
S T U D Y P E RI O D ..............................................................................................2 6
6. 1. 1
Scree ni n g - Vi sit 1 .............................................................................2 6
6. 1. 2
Vi sit 2................................................................................................2 6
6. 1. 3
Vi sit 3................................................................................................2 7
6. 1. 4
Vi sit 4................................................................................................2 8
6. 2
S u bject Wit h dra wal ............................................................................................2 9
7
A S S E S S M E N T S ...........................................................................................................3 0
7. 1
Scree ni n g ...........................................................................................................3 0
7. 1. 1
I nf or me d C o nse nt ..............................................................................3 0
7. 1. 2
De ntal  Hist or y ...................................................................................3 1
7. 1. 3
Well -Fi t Assess me nt, Ka p ur ( Ols ha n M o dificati on) I n de x .................3 1
7. 1. 4
Well Ma de Assess me nt ......................................................................3 2
7. 1. 5
F o o d Mi grati o n A de q uac y Deter mi nat i on ..........................................3 2
7. 2
Efficac y .............................................................................................................3 3
7. 2. 1
F o o d Occl usi o n  Testi n g I nc or p orati n g De nt ure Disl o d ge me nt 
Assess me nt ........................................................................................3 3
7. 2. 2
S u bject Q uesti o n naire ........................................................................3 5
7. 2. 3
De nt ure P h ot o gra p hs at Treat me nt Visits ...........................................3 5
7. 3
S af et y ................................................................................................................3 5
7. 3. 1
Or al  S oft Tiss ue ( O S T) E xa mi nat i on - E de nt ul o us .............................3 5
7. 3. 2
Pre g na nc y Testi n g ..............................................................................3 5
8
A D V E R S E E V E N T A N D O T H E R E V E N T S O F S P E CI A L I N T E R E S T 
R E P O R TI N G ................................................................................................................3 6
8. 1
Defi nit i ons of A d verse E ve nts a n d Seri o us A d verse E ve nts ...............................3 6
8. 1. 1
A d verse E ve nt ...................................................................................3 6
8. 1. 2
S eri o us A d verse E ve nt .......................................................................3 7
8. 2
Re p orti n g Peri o d ................................................................................................3 8
8. 2. 1
A d verse E ve nt ...................................................................................3 8
8. 2. 2
S eri o us A d verse E ve nt .......................................................................3 8
8. 3
Re p orti n g Pr oce d ures .........................................................................................3 8
8. 3. 1
A d verse E ve nt ...................................................................................3 9
8. 3. 2
S eri o us A d verse E ve nt .......................................................................3 9
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
2 4- O ct- 2 0 1 7 0 8: 4 9: 0 5
 
2 0 8 3 9 7 Cli ni c al Pr ot o c ol 2. d o c x
el d o _ c o ntr oll e d
2. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d b 1 b 9 1
Pa ge 6 of 6 2

S o di u m -calci u m mi xe d partial salt of p ol y( met h yl vi n y let her/ maleic aci d) a n d car b o x y met h ylcell ul ose
2 0 8 3 9 7
Fi nal Cli nica l Pr ot oc ol, 2 0 Oct 2 0 1 7
Gla x o S mit h Kli ne C o ns u mer Healt hcare C o nfi de ntial
Te m plate Ver si o n Effecti ve: 2 2-J u n-2 0 1 7
Pa ge 7 of  6 2
8. 3. 3
S p o ns or’s Re p orti n g Re q uire me nts t o Re g ulat or y  A ut h orities a n d 
Et hics C o m mit t e es .............................................................................4 0
8. 4
E val uat i n g A d verse E ve nts a n d Seri o us A d verse E ve nts ....................................4 1
8. 4. 1
Se verit y Assess me nt ..........................................................................4 1
8. 4. 2
Ca usalit y Assess me nt .........................................................................4 1
8. 5
Wit h dra wal D ue t o a n A d verse E ve nt a n d Seri o us A d verse E ve nts ....................4 2
8. 6
Pre g na nc y ..........................................................................................................4 2
8. 6. 1
Ti me Peri o d f or C ollect i n g Pre g na nc y I nf or mati on ............................4 2
8. 6. 2
A ct i on t o be Ta ke n if Pre g na nc y Occ urs ............................................4 2
8. 7
F o ll ow- u p of  A d verse E ve nts a n d Seri o us A d verse E ve nts................................. 4 3
8. 8
Defi nit i on o f a n d Pr oce d ure f or Re p orti n g Me dical De vice I nci de nts .................4 3
8. 8. 1
Defi nit i on o f a n I nci de nt ....................................................................4 4
8. 8. 2
Re p orti n g of a n I nci de nts a n d Malf u nct i ons .......................................4 4
8. 8. 3
F o ll ow- u p of  Me dical De vice I nci de nts..............................................4 5
8. 8. 4
Re g ulat or y  a n d Et hics Re p orti n g Re q uire me nts f or I nci de nts .............4 6
9
D A T A M A N A G E M E N T ..............................................................................................4 6
9. 1
S o urc e D oc u me nts/ Data ....................................................................................4 6
9. 2
Case Re p ort F or m ..............................................................................................4 6
9. 3
Data Ha n dli n g ....................................................................................................4 7
9. 3. 1
Q ueri es ..............................................................................................4 7
9. 4
Pr ocessi n g Patie nt Re p orte d O utc o mes ..............................................................4 7
9. 5
E xter nal Data .....................................................................................................4 8
1 0
S T A TI S TI C A L C O N SI D E R A TI O N S A N D D A T A A N A L Y S E S ................................. 4 8
1 0. 1
S a m ple Si ze Deter mi nat i on ................................................................................4 8
1 0. 2
Stati stical Met h o ds a n d A nal ytical Pla n .............................................................4 8
1 0. 2. 1
Defi nit i on o f A nal ysis P o p ulat i ons .....................................................4 9
1 0. 2. 2
E xcl usi o n of Data fr o m A nal ysis ........................................................4 9
1 0. 2. 3
D e m o gra p hic a n d Baseli ne C haracteristics .........................................4 9
1 0. 2. 4
Treat me n ts (st u d y dr u g/ pr o d uct, resc ue me dicati o n, ot her 
c o nc o mita nt t hera pies, c o m plia nce) ...................................................4 9
1 0. 2. 5
Pri mar y A nal ysis ...............................................................................4 9
1 0. 2. 6
S af et y A nal ysis ..................................................................................5 0
1 0. 2. 7
Ot her A nal yses ..................................................................................5 0
1 0. 2. 8
A d dit i onal A nal yses ...........................................................................5 0
1 0. 2. 9
Ha n dli n g of Dr o p o uts a n d Missi n g Data ............................................5 0
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
2 4- O ct- 2 0 1 7 0 8: 4 9: 0 5
 
2 0 8 3 9 7 Cli ni c al Pr ot o c ol 2. d o c x
el d o _ c o ntr oll e d
2. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d b 1 b 9 1
Pa ge 7 of 6 2

S o di u m -calci u m mi xe d partial salt of p ol y( met h yl vi n y let her/ maleic aci d) a n d car b o x y met h ylcell ul ose
2 0 8 3 9 7
Fi nal Cli nica l Pr ot oc ol, 2 0 Oct 2 0 1 7
Gla x o S mit h Kli ne C o ns u mer Healt hcare C o nfi de ntial
Te m plate Ver si o n Effecti ve: 2 2-J u n-2 0 1 7
Pa ge 8 of  6 2
1 0. 2. 1 0
I nteri m A nal ysis ................................................................................5 1
1 1
S T U D Y G O V E R N A N C E C O N SI D E R A TI O N S ...........................................................5 1
1 1. 1
Q ualit y C o ntr ol ..................................................................................................5 1
1 1. 2
Q ualit y Ass ura nce ..............................................................................................5 1
1 1. 3
Re g ulat or y  a n d Et hical C o nsi derati ons ...............................................................5 2
1 1. 3. 1
I nstituti o nal  Re vie w B oar d................................................................. 5 2
1 1. 3. 2
Et hical C o n d uct of t he St u d y ..............................................................5 2
1 1. 3. 3
S u bject I nf or mat i on a n d C o nse nt .......................................................5 2
1 1. 3. 4
S u bject Recr uit me nt ...........................................................................5 3
1 1. 3. 5
Re p orti n g of Safet y Iss ues a n d Serio us Breac hes of t he Pr ot o c o l or 
I C H G C P ...........................................................................................5 3
1 1. 4
P os ti n g of I nf or mati o n o n P u blicl y A vaila ble Cli nical Trial Re gisters................5 4
1 1. 5
Pr o visi o n of St u d y  Res ults t o I n vesti gat ors ........................................................5 4
1 1. 6
Rec or ds Rete nti o n ..............................................................................................5 4
1 1. 7
C o n di tio ns f or Ter mi nat i n g t he St u d y ................................................................5 5
1 1. 8
Defi nit i on o f St u d y  E n d/ E n d of St u d y...............................................................5 5
1 2
R E F E R E N C E S .............................................................................................................5 5
1 3
A P P E N DI C E S ..............................................................................................................5 7
1 3. 1
A B B R E VI A TI O N S ...........................................................................................5 7
1 3. 2
S u bject C o m plete d Q uesti o n naire ......................................................................5 9
1 3. 3
Pr o d uct A p plicat i on I nstr ucti o ns ........................................................................6 0
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
2 4- O ct- 2 0 1 7 0 8: 4 9: 0 5
 
2 0 8 3 9 7 Cli ni c al Pr ot o c ol 2. d o c x
el d o _ c o ntr oll e d
2. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d b 1 b 9 1
Pa ge 8 of 6 2

S o di u m -calci u m mi xe d partial salt of p ol y( met h yl vi n y let her/ maleic aci d) a n d car b o x y met h ylcell ul ose
2 0 8 3 9 7
Fi nal Cli nica l Pr ot oc ol, 2 0 Oct 2 0 1 7
Gla x o S mit h Kli ne C o ns u mer Healt hcare C o nfi de ntial
Te m plate Ver si o n Effecti ve: 2 2-J u n-2 0 1 7
Pa ge 9 of  6 2
Li st of t a bl e s
Ta ble 1 - 1
Sc he d ule of Act i vities........................................................................1 0
Ta ble 2 - 1
St u d y  O bjecti ves a n d E n d p oi nts.........................................................1 5
Ta ble 1 3 - 1
A b bre viat i on ......................................................................................5 7
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
2 4- O ct- 2 0 1 7 0 8: 4 9: 0 5
 
2 0 8 3 9 7 Cli ni c al Pr ot o c ol 2. d o c x
el d o _ c o ntr oll e d
2. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d b 1 b 9 1
Pa ge 9 of 6 2

S o di u m -calci u m mi xe d partial salt of p ol y( met h yl vi n y let her/ maleic aci d) a n d car b o x y met h ylcell ul ose
2 0 8 3 9 7
Fi nal Cli nica l Pr ot oc ol, 2 0 Oct 2 0 1 7
Gla x o S mit h Kli ne C o ns u mer Healt hcare C o nfi de ntial
Te m plate Ver si o n Effecti ve: 2 2-J u n-2 0 1 7
Pa ge 1 0 of  6 2
S C H E D U L E O F A C TI VI TI E S
T he sc he d ule of act i vities ta ble pr o vi des a n o ver vie w of t he pr ot oc ol visits a n d pr oce d ures.
T he i n vesti gat or ma y sc he d ule visi ts ( u n pla n ne d visit s) i n a d ditio n  to t hose liste d o n t he 
sc he d ule of  act i vities, i n or der t o c o n d uct e val uati o ns or assess me nts re q uire d t o pr otect t he 
well - bei n g of t he s u bject.
T a bl e 1- 1
S c h e d ul e of A cti viti e s
Pr o c e d ur e/ A s s e s s m e nt
S cr e e ni n g
St u d y P eri o d
Vi sit 1
B et w e e n 2- 3 0 d a y s
Vi sit 2
Tr e at m e nt 
P eri o d 1
B et w e e n 2- 3 0 d a y s
Vi sit 3
Tr e at m e nt 
P eri o d 2
B et w e e n 2- 3 0 d a y s
Vi sit 4
Tr e at m e nt 
P eri o d 3
Inf or m e d c o n s e nt
X
R e vi e w I n cl u si o n/ E x cl u si o n crit eri a
X
X
X
X
D e m o gr a p hi c s
X
M e di c al hi st or y 
X
C urr e nt / C o n c o mit a nt tr e at m e nt s
X
X
X
X
D e nt al hi st or y
X
O S T e x a mi n ati o n e d e nt ul o u s
X
X b
X b
X b
Cl e a n d e nt ur e s c
X
X
X
X
Crit eri a f or w ell m a d e a n d fitti n g 
d e nt ur e s (r et e nti o n, st a bilit y, 
cli ni c al a c c e pt a bilit y a n d d e nt ur e 
fi ni s h)
X
F o o d mi gr ati o n a d e q u a c y
X
S u bj e ct eli gi bilit y
X
Uri n e pr e g n a n c y t e st e
X
X d
X d
R a n d o mi s ati o n
X
S u bj e ct c o nti n u a n c e
X
X
X
Tr e at m e nt a p pli c ati o n a n d d e nt ur e 
i n s erti o na
X
X
X
Effi c a c y a s s e s s m e nt - F o o d 
o c cl u si o n t e sti n g
X
X
X
Effi c a c y a s s e s s m e nt - N u m b er of 
d e nt ur e di sl o d g e m e nt s
X
X
X
P h ot o gr a p h of d e nt ur e s ( su b s et of 
s u bj e ct s)
X
X
X
S u bj e ct -c o m pl et e d q u e sti o n n air e
X
X
X
A d v er s e e v e nt s
X
X
X
I n ci d e nt s
X
X
X
X
St u d y c o n cl u si o n
X
A b bre viati o ns: O S T = Oral S oft Tiss ue.
A n y seri o us a d verse e ve nt assesse d as relate d t o st u d y partici pati o n t hat occ urs s u bse q ue nt t o t he si g ni n g of i nf or me d c o nse nt a n d a n y 
a d verse e ve nt t hat occ urs s u bse q ue nt t o t he first d ose will be rec or de d.
a  T here will be a 6 0 5 mi n ute wait after de nt ures are i nserte d a n d t he c o m me nce me nt of t he f o o d occl usi o n testi n g.
b  At visits 2 -4 t h e O S T e xa mi nati o n will be perf or me d bef ore pr o d uct a p plicati o n a n d als o after t he de nt ure re m o val a n d pea n ut rec o ver y.
c  De nt ures will be clea ne d b ot h pri or t o a n d after t he f o o d mi grat or y a de q uac y ( V 1) or f o o d occl usi o n testi n g assess me nt ( V 2 -4).
d  Pre g na nc y testi n g at Visits 3 a n d 4 ar e o nl y r e q uir e d s h o ul d m ore t ha n 3 0 da ys h a v e el a ps e d b et w e e n t h e tr e at m e nt visit a n d t h e pr e vi o u s 
pre g na nc y test.
e  F or fe males of c hil d beari n g p ote ntial per Secti o n 7. 3. 2 .
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
2 4- O ct- 2 0 1 7 0 8: 4 9: 0 5
 
2 0 8 3 9 7 Cli ni c al Pr ot o c ol 2. d o c x
el d o _ c o ntr oll e d
2. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d b 1 b 9 1
Pa ge 1 0 of 6 2

S o di u m -calci u m mi xe d partial salt of p ol y( met h yl vi n y let her/ maleic aci d) a n d car b o x y met h ylcell ul ose
2 0 8 3 9 7
Fi nal Cli nica l Pr ot oc ol, 2 0 Oct 2 0 1 7
Gla x o S mit h Kli ne C o ns u mer Healt hcare C o nfi de ntial
Te m plate Ver si o n Effecti ve: 2 2-J u n-2 0 1 7
Pa ge 1 1 of  6 2
1
I N T R O D U C TI O N
De nt ure a d hesi ves ser ve t o i ncrease t he rete nti ve h ol d of  de nt ures t o t he oral muc osa a n d ma y 
als o re d uce t he i n gress of  fo o d particles u n der t he de nt ure.  Suc h parti cles ca n lea d t o 
irrit atio n of  the m uc osa a n d is of te n a maj or c o ncer n t o t he de nt ure wearer.  Curre nt 
u n dersta n di n g s u g gests t hat restrict i on of  fo o d parti cle i n gress is ac hie ve d t hr o u g h a tig hter 
de nt ure fit pr o vide d b y t he de nt ure a d hesi ve t hr o u g h its a bilit y t o b ot h a d here t he de nt ure t o 
t he m uc osa a n d t o o c clu de ga ps bet wee n t he de nt u re a n d t he m uc osa w hic h mi g ht ot her wise 
be s usce pti bl e t o fo o d p arti cle i n gress (Özca n, 2 0 0 5 ).  T he i ncrease d a d here nce t o t he m uc osa 
lea ds t o re d uce d m o ve me nt of  the de nt ure w hilst c he wi n g, lea di n g t o a re d ucti o n i n part icle 
mi grati o n u n der t he de nt ure (Tar bet, 1 9 8 0 ).  Ad diti o nall y , t he h y drat i on of  de nt ure a d hesi ves 
t hr o u g h c o ntact wit h sali va lea ds t o e x pa nsi o n of t he a d hesi ve, o c cl u di n g ga ps bet wee n t he 
de nt ure a n d t he u n derl yi n g m uc osa (Özca n, 2 0 0 5 ).  T he a d hesi ve ca n t heref ore be t ho u g ht of  
as f or mi n g a seal al o n g t he de nt ure b or ders w hic h pre ve nts i n gress o f s mall f o o d particles.
P u blis he d met h o d ol o gies f or e val uat i n g t he perf or ma nce of a de nt ure a d hesi ve at re d uci n g t he 
i n gress of f oo d p arti cles u n der t he de nt ure are rat her li mite d i n n u m bers.  Tar bet et al (Tar bet, 
1 9 8 0 ) ha d s u bjects s u bjecti vel y rate ( o n a te n-p oi nt scal e) w het her t he y e x perie nce d less f oo d
parti cles u n der t heir de nt ures aft er eat i n g f oo ds i ncl u di n g celer y, stea k, taff y a p ples a n d 
sa n d wic hes w he n usi n g a de nt ure a d hesi ve c o m p are d t o n o a d hesi ve.  This st u d y sh o we d a 
statisticall y si g nifica nt differe nce ( p < 0. 0 1) i n s u bjecti ve sc ore i n fav o ur of  use of  ad hesi ve 
c o mpare d t o n o a d hesi ve use.  Ah ma d et al (A h ma d, 2 0 0 9 ; A h ma d, 2 0 1 0 ) descri be d a 
q ua n titati ve met h o d ol o g y base d u p o n ha vi n g f ull y e de nt ulo us s u bjects c he w a prescri be d 
a mo u nt of  pea n uts w hile weari n g b ot h t heir ma xillar y a n d ma n di b ular de nt ures.  After 
c he wi n g t he pea n uts, t he s u bjects br us he d t heir de nt ures w hilst still weari n g t he m, ri ns e d wit h 
water t he n re m o v e d t h ei r d e nt ur es.  St u d y st aff t h e n r e mo v e d t h e p e a n ut p articles fr om t he fit 
s urfaces of  the de nt ures a n d a n y a d hesi ve fr o m t he de nt ures a n d t he de nt ure beari n g tiss ues, 
was he d a n d sie ve d t he pea n ut particles a n d dri e d t he particl es pri or t o wei g hi n g t he m.  This 
st u d y was a ble t o s h o w statisticall y si g nifica nt l o wer wei g ht of  pea n uts c ollecte d bet wee n 
s u bjects usi n g a n a d hesi ve c o m pare d t o n o a d hesi ve use.  The wei g ht of  pea n ut particles 
rec o vere d was n ot re p orte d i n f ull, h o we ver a mea n w ei g ht of  51 m g a n d 3 5 m g was f ou n d f or 
ma xillar y  de nt ures f or t he a d hesi ve a n d n o-a d hesi ve treat me nt gr o u ps res pecti vel y.
G S K 
ha ve pre vi o usl y s p o ns ore d st u dies at t he U ni versit y of  Buffal o usi n g a si milar 
met h o d ol o g y  to A h ma d (L 3 5 1 0 5 6 6, 2 0 0 8 ; M u n oz, 2 0 1 2 ).  The i ncl usi on crit erio n f or Ka p ur 
( Ols ha n m o difie d) was, h o we ver, less stri n ge nt, all o wi n g s u bjects wi t h a sc ore ≥6 t o be 
e nr o ll e d.  I n t his st u d y t w o cr e a m a d h esi v es a n d a strip a d hesi ve we r e c o mp ar e d t o t h e us e of 
n o a d hesi ve.  F or t he crea m  a d hesi ves, a t otal of 1. 6 g was use d s plit as 1. 0 g for m a xillar y a nd 
0. 6 g f or m a n di b ular de nt ures.  T he a d hesi ve was a p plie d as 3 s h ort strips o n t he ma xillar y a n d 
2 s h ort stri ps o n t he ma n di b ular de nt ur es.  For t he stri ps, 3 were use d f or t he ma xillar y 
de nt ures a n d 2 f or t he ma n di b ular de nt ures.  Pea n ut c o ns u m pt i on occ urre d 2 h o urs after 
de nt ure i nserti on.  This st u d y fo u n d t here was n o differe nce i n t he mass of  pea n ut particles 
mi grate d u n der t he de nt ur es bet wee n a n y of  the test gr o u ps, a n d t h at t he ma ss of particles 
rec o vere d was s mall, ≤2 0 m g f or c o m bi ne d mass fr o m b ot h ma xillar y a n d ma n di b ular de nt ures 
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
2 4- O ct- 2 0 1 7 0 8: 4 9: 0 5
 
2 0 8 3 9 7 Cli ni c al Pr ot o c ol 2. d o c x
el d o _ c o ntr oll e d
2. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d b 1 b 9 1
Pa ge 1 1 of 6 2

S o di u m -calci u m mi xe d partial salt of p ol y( met h yl vi n y let her/ maleic aci d) a n d car b o x y met h ylcell ul ose
2 0 8 3 9 7
Fi nal Cli nica l Pr ot oc ol, 2 0 Oct 2 0 1 7
Gla x o S mit h Kli ne C o ns u mer Healt hcare C o nfi de ntial
Te m plate Ver si o n Effecti ve: 2 2-J u n-2 0 1 7
Pa ge 1 2 of  6 2
f or eac h s u bject.  Furt her st u dies b y t he sa me pri nci ple i n vesti gat or ( PI) di d d e m o n strate t he 
a bilit y of  de nt ure a d hesi ves t o restrict t he i n gress of  fo o d u n der a de nt ures i n st u dies of  full 
(
; M u n oz -Vi ver os, 2 0 1 0 ) a n d parti al (M u n oz -Vi ver os, 
2 0 1 0 ; 
de nt ure wearers.  T hese st u di es use d mo difie d c he wi n g a n d la b orat or y 
pr oce d ures a n d m o re stri n ge nt i ncl usi on crit eria.  These st u dies all d e m o nstrate d statisticall y 
sig nifica nt re d ucti o ns i n f o o d particle e ntra p me nt w he n usi n g a n a d hesi ve c o m pare d t o t he use 
of  n o a d hesi ve.
F o ll owi n g t he l oss of  the cli nical facilit y at U ni versit y of  Buffal o, G S K s p o ns ore d a st u d y 
(2 0 5 9 1 5, 2 0 1 6 ) r u n at S alus Researc h usi n g a si milar met h o d ol o g y , but t hi s st u d y w as u n a bl e 
t o d e mo nstrate a differe nce i n pea n ut mi grat i on bet wee n use of  a n ad hesi ve a n d n o a d hesi ve.  
A ke y differe nce bet wee n t he Sal us st u d y  a nd t he pre vi o us B uffal o st u di es was t he met h o d of 
a p plicat i on of t he a d hesi ve t o t he de nt ure.
T he ai m of  this st u d y is t o esta blis h a relia ble met h o d ol o g y  that is a ble t o c haracterise t he 
perf or m a nce of  the a d hesi ve i n ter ms of  re d uci n g f oo d i n gress i n a f oo d occl usi o n 
met h o d ol o g y  w h er e s u bj e cts are as ke d t o e at p e a n uts i n a c o ntr olle d ma n ner a n d t he mass of 
pea n ut particles u n der t he de nt ure, p ost pea n ut c o ns u m pt i on, i s meas ure d a n d c o mpare d.
T his st u d y  will be c o n d ucte d at Salus Researc h i n t he U S A.
1. 1
M e c h a ni s m of A cti o n/I n di c ati o n
S o di u m -calci u m 
mi xe d 
partial  
salt 
of  
pol y( me t h yl vi n ylet her/ maleic 
aci d) 
a n d 
car b o x y met h ylcell ul ose is c urre nt l y i ncl u de d i n a de nt ure a d hesi ve mar kete d 
b y G S K.  
De nt ure a d hesi ves f u ncti on b y f or mi n g a n a d hesi ve la yer bet wee n t he de nt ure a n d g u m 
s urface t hat ca n act as a p h ysical s hiel d w hic h ca n help re d uce t he i n gress of f o o d particles.
T his st u d y  will be c o n d ucte d i n patie nts wit h c o m plete ma xillar y a n d ma n di b ular de nt ures.
1. 2
B a c k gr o u n d a n d R ati o n al e
T h e ai m of  t his met h o d de vel o p me nt st u d y  is t o assess if t he c ha n ges ma de t o t he o perati o nal 
pr oce d ures fr om st u d y 20 5 9 1 5 res ult i n a n i m pr o ve d s uccessf ul differe nt iati on bet wee n t he 
use of a de nt ure a d hesi ve a n d n o de nt ure a d hesi ve i n a m o del of f o o d occl usi o n.  
1. 2. 1
St u d y D e si g n R ati o n al e
Base d o n pre vi o us fi n di n gs, t he pea n ut occl usi o n met h o d ol o g y  has de mo n strate d t he a bility t o 
detect differe nces i n t he mass of  pea n ut parti c ulate meas ure d, a n d t his pr ot oc ol  will c o nti n u e 
t o use t he a d hesi ve diss ol uti o n a n d pea n ut retrie v al ste ps utilise d i n G S K st u dies 
 
  
W hilst t he o bj ecti ve meas ure of  pea n ut mass is t he pri mar y  en d p oi nt of  int erest i n t his st u d y, 
s u bject deri ve d o pi ni o n of efficac y will als o be meas ure d b y mea ns of a s u bject-c o mplete d
q uesti o n naire.  The n u m ber of  de nt ure disl o d ge me nts re p orte d b y t he s u bjects d uri n g t he 
c he wi n g of  the pea n uts will als o be c o llecte d a n d a nal yse d a n d t his, a n d t he q uest i on naire 
data, will be use d t o s u p p ort t he fi n di n gs of t he pea n ut mass meas ure.
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
2 4- O ct- 2 0 1 7 0 8: 4 9: 0 5
 
2 0 8 3 9 7 Cli ni c al Pr ot o c ol 2. d o c x
el d o _ c o ntr oll e d
2. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d b 1 b 9 1
Pa ge 1 2 of 6 2
C CI
C CI
C CI

S o di u m -calci u m mi xe d partial salt of p ol y( met h yl vi n y let her/ maleic aci d) a n d car b o x y met h ylcell ul ose
2 0 8 3 9 7
Fi nal Cli nica l Pr ot oc ol, 2 0 Oct 2 0 1 7
Gla x o S mit h Kli ne C o ns u mer Healt hcare C o nfi de ntial
Te m plate Ver si o n Effecti ve: 2 2-J u n-2 0 1 7
Pa ge 1 3 of  6 2
De nt u res are u ni q ue t o eac h i n di vi d ual.  Theref ore, t he m o st effic ie nt a p pr oac h t o e val uat i n g 
t heir p erf or m a nce wi t h differe nt a d hesi ves or ‘ n o a d hesi ve’ is a wi t hi n s u bject c o mparis o n 
(i.e. a cr oss o ver desig n).  De nt ure a d hesi ve is use d t o sec ure de nt ures i n t he m o ut h.  It f or ms a 
barrier t hat pre ve nts f oo d fr o m e nteri n g t he area bet wee n de nt ures a n d t he e de nt ulo us rid ge.  
T his st u d y will assess t he o bject i ve meas ure of  fo o d o c cl usi o n  while c he wi n g pea n uts as 
meas ure d 
b y mass of  pea n uts r etrie ve d, as well as s ubject i ve meas ures of  efficac y as 
meas ure d b y q uest i on naire data.
Pea n uts were c h ose n as t he m o d el  fo o d i n t his met h o d ol o g y  beca use t he y are a br ittle f oo d 
t hat, w he n masti c at e d, brea k i nto s mall particles t hat ca n be rec o vere d.  Pea n uts ha ve 
t heref ore bee n retai ne d as a m o d el  fo o d f or t hi s st u d y a nd t o allo w c o m par is o n wi t h pre vi o us 
data.
I n or der f or s u bjects t o be eli gi ble t he y must re p ort t hat t he y get f oo d tra p pe d u n der t heir 
de nt ures a n d t his m ust be e vi de nt f oll owi n g t he sta n dar dise d pea n ut mi grat i on a de q uac y 
testi n g at scree ni n g ( Visit 1).  This is t o e ns ure t hat meas ura ble a mo u nts of  pea n ut parti cles 
mi grate u n der t he de nt ure w he n n o de nt ure a d hesi ve is bei n g use d.  Whilst pea n ut aller g y is 
s pecific, pea n uts s u p plie d f or t his st u d y ma y t he msel ves be c o nta mi nate d wi t h ot her n uts 
o wi n g t o t he ma n ufact uri n g pr ocess.  Theref ore, s u bjects wi t h an y n ut aller g y are e xcl u de d 
fr om t his st u d y.  Su bjects wi t h te mp or o m a n di b ular j oi nt dis or ders are e xcl u de d s h o uld t he 
i n vesti gat or belie ves t hat t his c o uld affect t he s u bject’s partici pati o n, pri nci pall y re gar di n g t he 
a bilit y f or t he s u bject t o a de q uatel y c he w t he pea n uts.  Su bjects w h o use or ha ve e ver use d 
bis p h os p h o nate me d icati ons are s pecificall y e xcl u de d fr o m t his st u d y owi n g t o t he e n ha nce d 
ris k of  bis p h os p h o nat e-r elate d os t eo necr osi s of  the ja w ( B R O NJ) t hat is ass ociate d wi t h 
re d uce d tiss ue t oler a n c e t o f unct i on wi t h r e mo v a ble pr ost heses (Sal da n ha, 2 0 1 2 ).  S u bjects i n 
t his st u d y must be ha bi t ual wearers of  full de nt ures t o e ns ure t hat t he y are fa miliar wi t h 
c he wi n g wi t h their de nt ures i n place.  Su bjects w h o are xer ost o mic are e xcl u de d si nce t he 
pr o per f u nct i on of  de nt ure a d hesi ves re q uires a de q uate h ydrati o n f r o m sali va.
D uri n g t his st u d y, p h ot o gra p hs of  de nt ures wi t h pea n ut parti cles attac he d will be ta ke n.  The 
p ur p ose of  this is t o gat her re prese ntati ve p h ot o gra p hs of  the de nt ures t o ai d  in t he 
di sse mi nati on a n d i nter pretatio n of  t he r es ults, e. g. i n ma n uscri pt pre parati o n.  No pers o nall y 
i de ntifia ble i nf or mati on will be i ncl u de d i n t hese p h ot o gra p hs.  De m o gra p h y i nf or mat i on will 
be rec or de d as part of  this st u d y, i ncl u di n g a ge, race a n d ge n der.  I n acc or da nce wi t h t he 
U nite d States F o o d a n d Dr u g A d mi nistrati o n ( U S F D A) g ui deli nes (F D A, 2 0 0 5 ) t he et h ni cit y 
of  s u bjects will als o be ca pt ure d.
A n or al  sof t tiss ue ( O S T) e xa mi nat i on will b e c o n d ucte d at eac h tr e at me nt visi t bef ore 
treat me nt is a p plie d t o e ns ure t he s u bject’s or al  healt h is s ufficie nt t o all o w t he s u bject t o 
c o mplete t he assess me nts at t hat visit.  A furt her O S T e xa m will be p erf or m e d at eac h 
treat me nt visit after t he c o mpleti o n of  assess me nts t o assess f or p ossi ble A Es.
W hilst 
bli n di n g is a n i m p orta nt c o nsi derat i on f or a n y cli nical st u d y, t he o bj ecti ves of  this 
st u d y are n ot t o i n vesti gate pr o d uct efficac y, b ut t o de vel o p a met h o d ol o g y.   To f ulfil t he 
o bj ect i ves of  this st u d y it is n ot p ossi ble t o a de q uatel y mai nt ai n bli n di n g a n d t heref ore t his 
st u d y will be c o n d ucte d o pe n la bel.
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
2 4- O ct- 2 0 1 7 0 8: 4 9: 0 5
 
2 0 8 3 9 7 Cli ni c al Pr ot o c ol 2. d o c x
el d o _ c o ntr oll e d
2. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d b 1 b 9 1
Pa ge 1 3 of 6 2

S o di u m -calci u m mi xe d partial salt of p ol y( met h yl vi n y let her/ maleic aci d) a n d car b o x y met h ylcell ul ose
2 0 8 3 9 7
Fi nal Cli nica l Pr ot oc ol, 2 0 Oct 2 0 1 7
Gla x o S mit h Kli ne C o ns u mer Healt hcare C o nfi de ntial
Te m plate Ver si o n Effecti ve: 2 2-J u n-2 0 1 7
Pa ge 1 4 of  6 2
T he Ka p ur -Ols ha n i n de x is a c o m p osite sc ore base d u p o n sta bilit y an d rete nti on rati n gs f or 
t he ma xillar y a nd ma n di b ular de nt ures (Ka p ur, 1 9 6 7 ; Ols ha n, 1 9 9 2 ).  In t his st u d y, s u bject 
recr uit me nt will be tar gete d t o ac hie ve a p pr o xi matel y e q ual n u m bers of  su bjects i n t he l ow 
a n d hi g h Ka p ur -Ol s ha n gr o u ps.  The l ow Ka p ur -Ols ha n gr o u p is defi ne d as a c o mp osi t e 
Ka p ur -Ols ha n sc ore of  6- 1 4 (cli nicall y fair a n d g o o d de nt ures) a n d t he hi g h Ka p ur -Ols ha n 
sc ore as 1 5 - 1 8 (cli nicall y v er y  go o d de nt ures), val ues deri ve d fr om c o nsi deratio n of  pr e vio us 
st u d y data (2 0 5 9 1 5, 2 0 1 6 ).  The p ur p ose of  this a nal ysis is t o e x pl ore t he o pti m u m i ncl usi on 
criteria f or f ut ure st u dies.  Su bjects prese nt i n g wi t h a ver y l ow Ka p ur -Ol s ha n sc ore at 
Scree ni n g ( < 6), defi ne d as “ Cli nicall y P o or” ( Ols ha n, 1 9 9 2 ), will be e xcl u de d fr om t his st u d y.
De nt ure a d hesi ve ac hie ves its f unct i on b y p h ysical mea ns a n d o n c e c o mpletel y re m o v e d fr om 
t he de nt ure d oes n ot ha ve a n y resi d ual effects.  Theref ore, t he 2 - 3 0 da y p eri o d bet wee n eac h 
test da y is c o nsi dere d a deq uate rest f or t he oral s oft tiss ues fr om t he stresses of  masticat i on 
e nc o u ntere d i n t his st u d y.
Mar kete d de nt ure a d hesi ves are c o m m o nl y e xtr u de d b y t he c o ns u mer o nt o t he de nt ure eit her 
t hr o u g h a flat rib b o n n ozzl e wi t h instr ucti o ns f or use t o “ da b” t he pr o d u ct o nt o t he de nt ure 
(t he c o n ve nt i onal a p plicat i on patter n) or t hr o u g h a fi ner n ozzl e t hat e na bles t he a d hesi ve 
pr o d uct t o be m o re precisel y a p plie d s o all o wi n g a c o nt i n u o us bea d of  pr o d uct ar o u n d t he 
b or ders of  the de nt ures (c o nti n u o us strips a p plicatio n patter n).  In t his met h o d de vel o p me nt 
st u d y bot h  ap plicat i on met h o ds will be e v aluate d, wi t h the a d hesi ve a p plie d via a s yri n ge, t o 
assess if t he met h o d ol o g y  is c o m pat i ble wi t h either or b ot h a p plicat i on met h o ds.  The use of 
t he s yrin ge all o ws f or greate r c o ntr ol of  dose a n d a p plicat i on patter n a n d is c o nsiste nt wi t h 
pre vi o us st u dies.
1. 2. 2
Tr e at m e nt s
T hree treat me nt ar ms will be use d i n t his cr oss -o ver st u d y :-

S u per P oli gri p Free ( U S A mar ket place) a p plie d via a c o n ve nt i onal patter n.

S u per P oli gri p Free ( U S A ma r k et place) a p plie d via a c o nti n u o us strips patter n.

N o a d hesi ve.
A si n gle, c o m mo n  a d hesi ve will be use d ( S u per P oli grip F ree) wit h a c o m mo n d ose ( 1. 6 g) f or 
b ot h a p plicat i on met h o ds.  T he a d hesi ve will be e xtr u de d fr o m a pre -d ose d s yrin ge f oll owi n g 
t he a p plicati on i nstr uctio ns.  Su per P oli gri p Free has bee n selecte d as t he a d hesi ve i n t his 
st u d y as it is a c urre ntl y mar kete d pr o d uct a n d is c o nsi dere d a re prese ntati ve de nt ure a d hesi ve.  
1. 6 g of a d hesi ve per treat me nt will be a p plie d t o eac h s u bject’s de nt ures , a n a mo u nt c o nsiste nt 
wi t h that use d i n pre vi o us st u dies a n d will t heref ore facilitate c o mparis o n of  data fr om t his 
st u d y wi t h pre vi o us w or k.  This d ose will be s plit as 1. 0 0 ± 0. 0 5 g f or t he ma xillar y a n d 
0. 6 0 ± 0. 0 5 g f or t he ma n di b ular de nt ures i n acc or da nce wi t h c o ns u mer’s n or m al distri b uti on of 
a d hesi ve.
A n o a d hesi ve ne gat i ve c o ntr ol treat me nt has bee n c h ose n t o pr o vi de a c o nti n ual refere nce 
p oi nt t o all o w i nt er pretatio n of  t he r es ults a n d t o f a cilit at e c o mparis o n of  t he r es ults fr om t his 
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
2 4- O ct- 2 0 1 7 0 8: 4 9: 0 5
 
2 0 8 3 9 7 Cli ni c al Pr ot o c ol 2. d o c x
el d o _ c o ntr oll e d
2. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d b 1 b 9 1
Pa ge 1 4 of 6 2

S o di u m -calci u m mi xe d partial salt of p ol y( met h yl vi n y let her/ maleic aci d) a n d car b o x y met h ylcell ul ose
2 0 8 3 9 7
Fi nal Cli nica l Pr ot oc ol, 2 0 Oct 2 0 1 7
Gla x o S mit h Kli ne C o ns u mer Healt hcare C o nfi de ntial
Te m plate Ver si o n Effecti ve: 2 2-J u n-2 0 1 7
Pa ge 1 5 of  6 2
st u d y with pre vi o us w or k, a n d is re prese ntati ve of  a si g nifica nt n u m ber of  de nt ure wearers 
w h o c urre ntl y d o n ot use a n a d hesi ve.
C o m plete i nf or mati on f or t his c o m p o u n d 
ma y 
be f ou n d i n t he si n gle refere nce safety 
d oc u m e nt ( S R S D), w hic h for t his st u d y  is t he S af et y State me nt .
2
S T U D Y O B J E C TI V E S A N D E N D P OI N T S
T a bl e 2- 1
St u d y O bj e cti v e s a n d E n d p oi nt s
O bj e cti v e s
E n d p oi nt s
Pri m ar y
T o e v al u at e t h e m a s s of p e a n ut p arti cl e s t h at mi gr at e 
u n d er t h e d e nt ur e s d uri n g a f o o d o c cl u si o n 
m e t h o d ol o g y w h e n d e nt ur e a d h e si ve i s a p pli e d p er 
c o n v e nti o n al p att er n.
M a s s of p e a n ut s u n d er c o m bi n e d m a xill ar y 
a n d m a n di b ul ar d e nt ur e s.
E x pl or at or y
T o e v al u at e t h e m a s s of p e a n ut p arti cl e s t h at mi gr at e 
u n d er t h e d e nt ur e s d uri n g a f o o d o c cl u si o n 
m e t h o d ol o g y w h e n d e nt ur e a d h e si ve i s a p pli e d p er 
c o nti n u o u s stri p s p att er n a n d w h e n n o a d h e si v e i s 
u s e d.
M a s s of p e a n ut s u n d er c o m bi n e d m a xill ar y 
a n d m a n di b ul ar d e nt ur e s.
T o e v al u at e t h e m a s s of p e a n ut p arti cl e s t h at mi gr at e 
u n d er t h e m a xill ar y a n d m a n di b ul ar d e nt ur e s d uri n g a 
f o o d o c cl u si o n m et h o d ol o g y w h e n d e nt ur e a d h e si ve 
i s a p pli e d p er c o n ve nti o n al p att er n, c o nti n u o u s stri p s 
p att er n a n d w h e n n o a d h e si v e i s u s e d.
M a s s of p e a n ut s u n d er m a xill ar y d e nt ur e s.
M a s s of p e a n ut s u n d er m a n di b ul ar d e nt ur e s.
T o e v al u at e s u bj e ct r e s p o n s e s t o 2 q u e sti o n s d uri n g 
a f o o d o c cl u si o n m et h o d ol o g y w h e n d e nt ur e 
a d h e si v e i s a p pli e d p er c o n v e nti o n al p att er n, 
c o nti n u o u s stri p s p att er n a n d w h e n n o a d h e si v e i s 
u s e d.
S u bj e ct c o m pl et e d q u e sti o n n air e.
T o e x pl or e t h e p erf or m a n c e of a m ar k et e d d e nt ur e 
a d h e si v e w h e n a p pli e d p er c o n v e nti o n al p att er n t o n o 
a d h e si v e u s e f or s u bj e ct s i n t h e l o w a n d hi g h K a p ur -
Ol s h a n s u b gr o u p s.
M a s s of p e a n ut s u n d er c o m bi n e d m a xill ar y 
a n d m a n di b ul ar d e nt ur e s i n e a c h s u b gr o u p 
(l o w a n d hi g h K a p ur -Ol s h a n s c or e s).
T o e x pl or e t h e r el ati o n s hi p b et w e e n t h e n u m b er of 
s u bj e ct -r e p ort e d d e nt ur e di sl o d g e m e nt s w h e n 
d e nt ur e a d h e si v e i s a p pli e d p er c o n v e nti o n al p att er n, 
c o nti n u o u s stri p s p att er n a n d w h e n n o a d h e si v e i s 
u s e d.
T h e n u m b er of s u bj e c t r e p ort e d d e nt ur e 
di sl o d g e m e nt s d uri n g c h e wi n g.
S af et y
T o a s s e s s t h e t ol er a bilit y of m ar k et e d d e nt ur e 
a d h e si v e ( S u p er P oli gri p Fr e e).
Tr e at m e nt e m er g e nt a d v er s e e v e nt s.
T his st u d y  is a met h o d de vel o p me nt st u d y a n d t heref ore t here is n o f or mal s uccess crit erio n.
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
2 4- O ct- 2 0 1 7 0 8: 4 9: 0 5
 
2 0 8 3 9 7 Cli ni c al Pr ot o c ol 2. d o c x
el d o _ c o ntr oll e d
2. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d b 1 b 9 1
Pa ge 1 5 of 6 2

S o di u m -calci u m mi xe d partial salt of p ol y( met h yl vi n y let her/ maleic aci d) a n d car b o x y met h ylcell ul ose
2 0 8 3 9 7
Fi nal Cli nica l Pr ot oc ol, 2 0 Oct 2 0 1 7
Gla x o S mit h Kli ne C o ns u mer Healt hcare C o nfi de ntial
Te m plate Ver si o n Effecti ve: 2 2-J u n-2 0 1 7
Pa ge 1 6 of  6 2
3
S T U D Y D E SI G N A N D S U B J E C T P O P U L A TI O N
T his will be a si n gle ce ntre, c o nt r olle d, o pe n la bel, ra n d o mise d, t hree-treat me nt, t hree-peri o d, 
cr oss-o ver desi g n i n s u bjects wi t h full u p per a n d f ull l ower de nt ures.  Eac h tr e at me nt p eri o d 
will c o nsist of o n e da y of testi n g wit h at least t w o da ys bet wee n a djace nt treat me nt visits.
A p pr o xi matel y  4 8 ( ma xi m u m 50) healt h y s u bjects wi t h bot h  ma xillar y a n d ma n di b ular f ull 
de nt ures will be e nr olle d i n t his st u d y.  In t his st u d y, s u bject recr uitme nt  will be tar gete d t o 
ac hie ve a p pr o xi matel y e q ual n u m bers of  su bjects i n t he l ow a n d hi g h Ka p ur -Ols ha n gr o u ps.  
T he l ow Ka p ur -Ols ha n gr o u p is defi ne d as a c o mp osi t e Ka p ur -Ol s ha n sc ore of  6- 1 4 
(cli nicall y fair a n d g o o d de nt ures) a n d t he hi g h Ka p ur -Ols ha n sc ore as 1 5 - 1 8 (cli nicall y ver y 
g o o d de nt ures).
At  the scree ni n g visit, f oll owi n g a n O S T e xa mi nat i on, eac h s u bject’s de nt ures ( u p per a n d 
l ower) will be clea ne d t he n assesse d f or rete ntio n a n d sta bilit y usi n g t he Ka p ur I n de x ( Ols ha n 
M o dificat i on) (Ka p ur, 1 9 6 7 ; Ols ha n, 1 9 9 2 ) a n d w het her t he y are well ma de.  Onl y  th ose 
s u bjects wi t h de nt ures ( b ot h u p per a n d l ower) t hat satisf y b ot h of  these crit eria will u n der g o 
t he f oo d mi grat i on a de q uac y assess me nt t o pr o vi de e vi de nce of  ade q uate pea n ut particle 
mi grati o n u n der t he de nt ures aft er c he wi n g a p orti o n of  pea n uts.  A vis ual o b ser vati on a n d 
rati n g of l ocatio n a n d e xt e nt of  p e a n ut p article mi grati o n a de q uac y m ust i n dicate > 0 o n a 0 –
3 scale.  S u bjects meet i n g all t he i ncl usi on cri t eria wit h no e xcl usi o ns will  t he n be ra n d o mise d 
at Visit 2.  Su bject recr uitme nt  will be c o ntr olle d t o e ns ure 5 0 ± 1 0 % of  t he s u bjects will be i n 
eac h of t he l ow a n d hi g h Ka p ur -Ol s ha n gr o u ps [t he l ow Ka p ur -Ols ha n gr o u p is defi ne d as a 
c o mp osi te Ka p ur-Ols ha n sc ore of 6 -1 4 (cli nicall y fair a n d g o o d de nt ures) a n d t h e hig h Ka p ur -
Ol s ha n sc ore as 1 5 - 1 8 (cli nicall y ver y g o o d de nt ures)].  There will be bet wee n 2 - 3 0 da ys 
bet wee n t he scree ni n g visit a n d t he f or test da y .
O n eac h t est da y ( Visits 2 -4) s u bjects will u n der g o a n O S T e xa mi nat i on a n d ha ve t heir 
de nt ures clea ne d. Treat me nt  ( or n o tr e at me nt as per t he ra n d o misatio n sc he d ule) will t he n be 
a p plie d as per t he a p plicati o n i nstr uctio ns a n d t he de nt ures w or n b y t he s u bject.  The n, 6 0 5 
mi n utes aft er i nserti n g t heir de nt ures eac h s u bject will be gi ve n a sta n dar dise d p orti o n of 
pea n uts t o c o ns u me, f oll owi n g a prescri be d c he wi n g a n d s wall o wi n g met h o d. 
 
Whilst 
c he wi n g t he pea n uts s u bjects will rec or d t he n u m ber of  de nt ure di slo d ge me nts t hat occ ur 
d uri n g t he c he wi n g pr oce d ure.  Aft er t his, s u bjects will rinse t heir m o ut h wi t h water .  The 
e xa mi ner will t he n r e mo v e t he l ow er de nt ure a n d a n y pea n ut parti cles or a d hesi ve re mai ni n g 
o n t he ma n di b ular rid ge will be r e mo v e d usi n g ga uze.  T he e xa mi ner will t he n r e mo ve t he 
u p per de nt ure a n d a n y pea n ut particles or a d hesi ve re mai ni n g o n t he p al ate will be r e mo ve d 
usi n g ne w ga uze.   T h e s u bject will t he n c o m p lete a q uest i on naire o n efficac y a n d a f urt her 
O S T e xa mi nat i on will be perf or me d.
F or a s u bset of  su bjects t he fit surface of  their de nt ures will be p h ot o gra p he d bef ore pea n uts 
are c o llecte d fr om t he fit surf ace.  These s u bjects will be selecte d at t he discreti o n of  the 
I n vesti gat or, b ut all o w f or a v ari et y of  de nt ure sizes a n d fit to be re prese nte d.  It is e x pecte d 
t hat a p pr o xi matel y 5 sets of  de nt ures be p h ot o gra p he d per treat me nt gr o u p , a n d w here 
p ossi ble t hat c o nsiste nc y of  su bjects bet wee n tr e at me nts is mai ntai ne d (i.e. a s u bject will be 
i de ntifie d at visit  2 as bei n g s uita ble f or de nt ure i ma gi n g a n d will ha ve t heir de nt ures 
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
2 4- O ct- 2 0 1 7 0 8: 4 9: 0 5
 
2 0 8 3 9 7 Cli ni c al Pr ot o c ol 2. d o c x
el d o _ c o ntr oll e d
2. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d b 1 b 9 1
Pa ge 1 6 of 6 2

S o di u m -calci u m mi xe d partial salt of p ol y( met h yl vi n y let her/ maleic aci d) a n d car b o x y met h ylcell ul ose
2 0 8 3 9 7
Fi nal Cli nica l Pr ot oc ol, 2 0 Oct 2 0 1 7
Gla x o S mit h Kli ne C o ns u mer Healt hcare C o nfi de ntial
Te m plate Ver si o n Effecti ve: 2 2-J u n-2 0 1 7
Pa ge 1 7 of  6 2
p h ot o gra p he d at visits 2, 3 a n d 4 h o we ver, s h o uld s u bject dr o p o uts or ot her reas o ns 
necessitate, s u bjects ca n be s u bstit ute d).
Pea n ut parti cles will t he n be c ollecte d fr o m t he fit surf a c es of t he de nt ures a n d t he ga uzes a n d 
w ei g he d t o e val uate t he mass of f oo d particles t h at ha d mi grate d u n der t he de nt ure ( kee pi n g 
t he particles ass ociate d wit h t he u p per a n d l o wer de nt ures se parate).
T hese pr oce d ures will be re peate d i n a cr oss o ver ma n ner.  There will be bet wee n 2 - 3 0 da ys 
bet wee n treat me nt visits t o all o w f or rec o ver y  fr o m t he masticatio n pr oce d ures.
S af et y will be assesse d b y e xa mi nat i on of  the or al  sof t tiss ues at t he Scree ni n g Vis it an d 
bef ore a n d after eac h treat m e nt assess me nt has bee n c o mplete d at eac h of  t he treat me nt visits.  
A b n or m alities re p orte d aft er t he s u bject’s first use of  treat me nt will be c o nsi dere d as a d verse 
e ve nts ( A Es).  I nci de nts will be rec or de d fr o m t he first use of a me dical de vice.
4
S U B J E C T S E L E C TI O N
T his st u d y ca n f ulfil its o bject i ves o nl y if a p pr o priate s u bjects are e nr olle d.  The f oll o wi n g 
eli gi bilit y crit eria are desi g ne d t o select s u bjects f or w h o m part ici pati on i n t he st u d y is 
c o nsi dere d a p pr o priat e.  All r el e v a nt me d ical a n d n o n me dical c o n ditio ns s h o uld be ta ke n i nto 
c o nsi derati o n w he n deci di n g w het her a partic ular s u bject is s uita ble f or t his pr ot oc ol.
4. 1
I n cl u si o n Crit eri a
S u bject eli gi b ility s h o uld be assesse d a n d d oc u me nte d b y a n a p pr o priate me m ber of  the 
i n vesti gat or’s st u d y t e a m bef ore s u bjects are e nr olle d i n t he st u d y.
S u bjects m ust meet all of  t he f oll owi n g i ncl usi on criteria t o be eli gi ble f or e nr o l me nt i nt o t he 
st u d y:
1)
E vi de nce of a pers o nall y si g ne d a n d date d i nf or me d c o nse nt d oc u m e nt i n dicati n g t hat t h e 
s u bject has bee n i nf or me d of  all pert i ne nt as pects of  the st u d y befor e a n y assess me nt is 
perf or m e d.
2)
Male or fema le w h o , at  the ti me of  scree ni n g , are bet wee n t he a ges of  18 a n d 8 5 ye ars, 
i ncl usi ve.
3)
Willi n g 
a n d a ble t o c o m p l y wi t h sc he d ule d visit s, treat me nt pl a n, a n d ot h er stu d y 
pr oce d ures.
4)
Heal t h y, defi ne d as i n ge neral g o o d p h ysical healt h, as j u d ge d b y  t he i n vesti gat or.
5)
Self -re p orts e x perie nce of getti n g f o o d tra p pe d u n der t heir de nt ure.
6)
Is a n ha bit ual wearer of b ot h of  t heir de nt ures defi ne d as s u bjects w h o wear b ot h of  t heir 
de nt ures f or t he maj orit y of  t h eir ti me w hilst a wa ke.
7)
Fe male s of  chil d beari n g p ot e nti al an d at ris k f or pre g na nc y m ust a gree t o use a hi g hl y 
effect i ve met h o d of  c o ntrace ptio n t hr o u g h o ut t he st u d y  a nd f or 1 d a y aft er t h e last d ose of 
assi g ne d tr e at me nt.  Fe male s u bjects w h o are n ot of  chil d beari n g p ote nti al m ust me et 
re q uire me nts i n Sect i on 4. 4. 2 .
8)
Ha ve de nt ure pr ost hes es t hat f ulfil all of t he f oll o wi n g:
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
2 4- O ct- 2 0 1 7 0 8: 4 9: 0 5
 
2 0 8 3 9 7 Cli ni c al Pr ot o c ol 2. d o c x
el d o _ c o ntr oll e d
2. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d b 1 b 9 1
Pa ge 1 7 of 6 2

S o di u m -calci u m mi xe d partial salt of p ol y( met h yl vi n y let her/ maleic aci d) a n d car b o x y met h ylcell ul ose
2 0 8 3 9 7
Fi nal Cli nica l Pr ot oc ol, 2 0 Oct 2 0 1 7
Gla x o S mit h Kli ne C o ns u mer Healt hcare C o nfi de ntial
Te m plate Ver si o n Effecti ve: 2 2-J u n-2 0 1 7
Pa ge 1 8 of  6 2
a)
A q ualif yi n g c o n ve nt i onal acr ylic f ull de nt ure i n b ot h t he u p per a n d l o wer arc h.
b)
De nt ures are well fitti n g ( Ka p ur ( Ols ha n M o dificati o n) Rete nti o n a n d Sta bilit y I nde x 
S u m  Sc ore ≥6) (Ols ha n, 1 9 9 2 ) wit h n o i n di vi d ual sta bilit y or rete nti o n sc ores < 1.
c)
De nt ures are well m a de (acc or di n g t o t he well -ma de assess me nt).
d)
Has a pea n ut particle mi grati o n rat i n g > 0 f or eac h de nt ure.
4. 2
E x cl u si o n Crit eri a
S u bjects w h o m eet a n y of t he f ollo wi n g e xcl usi o n  criteria will n ot be eli gi ble f or e nr ol me nt i n 
t he st u d y:
1.
A n i n vesti gati o nal sit e staff me m ber di rectl y i n v ol ve d i n t he c o n d u ct of t he st u d y or t heir 
fa mil y me m ber, sit e staff me m bers ot h er wise s u per vise d b y t he i n vesti gat or, or a n 
e mpl o y ee of t he s p o ns or direct l y i n v ol ve d i n t he c o n d uct of t he st u d y.
2.
P arti cip ati o n i n a n y ot h er cli nical st u d y in v o l vi n g i n vesti gati onal dr u gs, c os met ics or 
me dical de vices wit hi n 3 0 da ys pri or t o st u d y  e ntr y a nd/ or d uri n g st u d y  partici pat i on.
3.
Ac ute or c hr o nic me dical or ps yc hiatric c o n diti o n or lab orat or y  ab n or m alit y that ma y 
i ncrease t he ris k ass o ciate d wit h 
st u d y partici pat i on or i n vesti gati onal pr o d uct 
a d mi nistrati o n or ma y i nterfere wi t h the i nter pretatio n of  st u d y res ults a n d, i n t h e 
j u d g me nt of  the i n vesti gat or, w o ul d ma ke t he s u bject i na p pr o priate f or e ntr y int o t his 
st u d y.
4.
Pre g na nt fe male s u bjects.
5.
Br eastfee di n g fe male s u bjects.
6.
K n o w n or s us pecte d i ntol era nce or h y perse nsit i vity t o t he st u d y materials ( or cl o sel y 
r elate d c o mp o u n ds) or a n y  of t heir state d i n gre die nts. 
7.
U n willi n g or u na ble t o c o m pl y wit h t he Lifest yle G ui deli nes descri be d i n t his pr ot oc o l. 
8.
Hi st or y of s wallo wi n g diffic ul ties or c h o ki n g.
9.
C urre nt l y ta ki n g or ha ve ta ke n a bis p h os p h o nate dr u g (i.e., F osa ma x® , Act o nel ® , B o ni va® ) 
f or treat me nt of oste o p or osis .
1 0. A n y cli nicall y si g nifica nt or rele va nt or al  ab n or m alit y (e. g. t e mp or o m a n di b ular j oi nt
[ T MJ] pr o ble ms) t hat, i n t he o pi ni o n of  the i n vesti gat or, c o ul d affect t he s u bject’s 
parti ci pat i on i n t he st u d y.
1 1. K n o w n aller g y  t o pea n uts or a n y ot her n ut.
1 2. A n y c o n di tio n or m e dicat i on w hic h, i n t he o pi ni o n of  t he i n vestig at or, i s c urre ntl y ca usi n g 
xer ost o mia.
1 3. Rece nt hist or y  ( wit hi n t he last year) of alc o h ol or ot her s u bsta nce a b use.
1 4. O S T e xa mi nat i on fi n di n gs s uc h as st o mat itis, o pe n s ores, lesio n s, re d ness or s welli n g 
w hic h i n t he o pi ni o n o f t he i n vest i gat or, w o ul d i nterfere wit h t he c o n d uct of t he st u d y.
                                               
® F osa ma x is a re gistere d tra de mar k of Merc k & C o.
® Act o nel is a re gistere d tra de mar k of War ner C hilc ott C o m pa n y, L L C.
® B o n i va is a re gistere d tra de mar k of Ge ne ntec h.
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
2 4- O ct- 2 0 1 7 0 8: 4 9: 0 5
 
2 0 8 3 9 7 Cli ni c al Pr ot o c ol 2. d o c x
el d o _ c o ntr oll e d
2. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d b 1 b 9 1
Pa ge 1 8 of 6 2

S o di u m -calci u m mi xe d partial salt of p ol y( met h yl vi n y let her/ maleic aci d) a n d car b o x y met h ylcell ul ose
2 0 8 3 9 7
Fi nal Cli nica l Pr ot oc ol, 2 0 Oct 2 0 1 7
Gla x o S mit h Kli ne C o ns u mer Healt hcare C o nfi de ntial
Te m plate Ver si o n Effecti ve: 2 2-J u n-2 0 1 7
Pa ge 1 9 of  6 2
1 5. Use of  an y me dicat i on t hat, i n t he o pi ni o n  of t he i n vesti gat or, w o ul d i nterfere wi t h the 
c o n d uct of t he st u d y.
1 6. A seri o us c hr o nic disease re q uiri n g i nter mitte nt h os pital visits.
1 7. Ha vi n g bee n pre vi o usl y  e nr olle d i n t his st u d y.
1 8. A n y s u bject w h o, i n t he o p i ni on of t he i n vest i gat or, s h o ul d n ot partici pate i n t he st u d y.
4. 3
R a n d o mi s ati o n Crit eri a
S u bjects will be ra n d o mise d i nto t he st u d y pr o vi de d t he y ha ve satisfie d all s u bject selecti on 
criteria.  S u bjects s h o uld be recr uite d s o t hat, at  scree ni n g, a p pr o xi mately 5 0 % ( 4 0-6 0 %) of 
t he s u bject p o p ulat i on attai ns a Ka p ur -Ols ha n S c or e of  6- 1 4 a n d a p pr o xi matel y 5 0 % ( 4 0-
6 0 %) attai ns a Ka p ur -Ol s ha n Sc ore of 1 5- 1 8.
4. 4
Lif e st yl e G ui d eli n e s
D uri n g t he e nt ire st u d y (scree ni n g – L S L V):

S u bjects will n ot be per mitte d t o ha ve a n y d e nt al / de nt ure w or k perf or me d d uri n g t he 
ti me t he y are i n t he st u d y, u nless di sc usse d a n d per mitte d b y t he e xa mi ner.  T his is t o 
ass ure t hat t he de nt ure fit will n ot be altere d d uri n g t he st u d y.

S u bjects are n ot per mitte d t o use of bis p h os p h o nates as per e xcl usi o n cri t erio n 9.
D uri n g t he treat me nt visit s ( Visits 2-4):

S u bjects will n ot be all o we d t o use t o bacc o or nic oti ne -c o ntai ni n g pr o d ucts f oll owi n g 
de nt ure i nserti o n u nt il aft er t heir de nt ures are ret ur ne d at c o mpl et i on of  the f oo d 
occl usi o n  t estin g .

S u bjects will n ot be a ble t o use a n y or al  healt hcare pr o d uct ot her t ha n t hose s u p plie d 
b y t he i n vesti gat or f oll owi n g de nt ure i nserti o n u ntil af t er t h eir de nt ures are ret ur ne d at 
c o mplet i on of t he f o o d occl usi o n testi n g.
4. 4. 1
M e al s a n d Di et ar y R e stri cti o n s
S u bje cts will n ot be all o we d t o c o ns u me a n y fo o d (i ncl u di n g c he wi n g g u m ) or dri n ks 
f oll owi n g de nt ure i nserti o n u nt il aft er t heir de nt ures are ret ur ne d at c o mpleti o n of  the f oo d 
occl usi o n  testin g ( wit h the e xce pt i on of  small si ps of  water t o alle viate t hirst, t o ai d c he wi n g 
t he pea n uts or t o assist wit h me dicat i on).
4. 4. 2
C o ntr a c e pti o n
All fe male s u bjects w h o are of  chil d beari n g p ote nt ial a n d are se x uall y acti ve a n d at ris k f or 
pre g na nc y m ust a gree t o use a hi g hl y effect i ve met h o d of  co ntrace pti o n c o nsiste nt l y a n d 
c orr ectl y f or t he d urati o n of  the act i ve st u d y perio d a n d f or 1 da y aft er t he last d ose of 
i n vesti gati onal pr o d uct.  The i n vesti gat or or desi g nee, i n c o ns ult atio n wi t h the s u bject, will 
c o nfir m ver ball y t hat t he s u bject is usi n g o ne of  the met h o ds of  co ntrace p tio n fr o m the 
per mitte d list of  co ntrace pti o n met h o ds (see bel o w) a n d has bee n i nstr ucte d b y a me dicall y 
q ualifie d i n di vi d ual i n its c o nsiste nt a n d c orrect use.  Su bjects nee d t o affir m t hat t he y meet 
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
2 4- O ct- 2 0 1 7 0 8: 4 9: 0 5
 
2 0 8 3 9 7 Cli ni c al Pr ot o c ol 2. d o c x
el d o _ c o ntr oll e d
2. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d b 1 b 9 1
Pa ge 1 9 of 6 2

S o di u m -calci u m mi xe d partial salt of p ol y( met h yl vi n y let her/ maleic aci d) a n d car b o x y met h ylcell ul ose
2 0 8 3 9 7
Fi nal Cli nica l Pr ot oc ol, 2 0 Oct 2 0 1 7
Gla x o S mit h Kli ne C o ns u mer Healt hcare C o nfi de ntial
Te m plate Ver si o n Effecti ve: 2 2-J u n-2 0 1 7
Pa ge 2 0 of  6 2
t he criteria f or t he c orrect use of  at least 1 of  the selecte d met h o ds of  co ntrace pti o n.  The 
i n vesti gat or or his or her desi g nee will disc uss wi t h the s u bject t he nee d t o use hi g hl y 
effect i ve c o ntrace ptio n c o nsiste ntl y a n d c orrectl y acc or di n g t o t he sc he d ule of  act i vities a n d 
d oc u m e nt s uc h c o n versat i on i n t he s u bject’s c hart.  In a d ditio n, t he i n vesti gat or or his or her 
desi g nee will i nstr uct t he s u bject t o call i m me diatel y if t he selecte d c o ntrace pti o n met h o d is 
di sc o nti n ue d or if pre g na nc y is k n o w n or s us pecte d i n t he s u bject. 
Hi g hl y  effecti ve met h o ds of  co nt race pti o n are t hose t hat, al o ne or i n c o m bi nat i on, res ult i n a 
fail ure rate of  less t ha n 1 % per year w he n use d c o nsiste nt l y a n d c orrectl y (i.e., perfect use) 
a n d i ncl u de t he f oll o wi n g:
1.
Esta blis he d use of oral , inserte d, i njecte d, tra ns der mal, or i m pla nte d h or m o nal met h o ds of 
c o ntrace pti o n is all o we d pr o vi de d t he s u bject pla ns t o re mai n o n t he sa me tr e at me nt 
t hr o u g h o ut t he e nt ire st u d y an d has bee n usi n g t hat h or m o nal c o ntrace pti ve f or a n 
a de q uate peri o d of ti me t o e ns ure effect i ve ness as dee me d a p pr o priate b y t he i n vesti gat or.
2.
C orrectl y  place d c o p per-c o nt ai ni n g i ntra uteri ne de vice (I U D). 
3.
Male c o n d o m  or fe m al e c o n d o m use d WI T H a s per mici de (i.e., f oa m, g el, fil m, crea m, or 
s u p p osit or y).  For c o u n tries w here s per mici de is n ot a vaila ble or c o n d o m  plus s per mici de 
is n ot acce pte d as hi g hl y effect i ve c o ntrace pti o n, t his o pti o n is n ot a p pr o priate.
4.
Male sterilisati o n wit h a bse nce of s per m i n t he p ost -vasect o m y ejac ulate.
5.
Bilateral t u bal li gati on / bilateral sal pi n gect o m y or bilateral t u bal o c cl usi ve pr oce d ur e 
( pr o vide d t hat occl usi o n  has bee n c o nfir me d i n acc or da nce wit h t he de vice’s la bel).
6.
Fe male w h o meets t he criteria f or n o n -c hil d beari n g p ote ntial as descri be d bel o w.  
Fe male s u bjects of  no n -c hil d beari n g p ote nti al m ust meet at least o ne of  the f oll owi n g 
criteria:
a.
Ac hie ve d p ost m e n o pa usal stat us, defi ne d as f oll o ws: cessat i on of  re g ular 
me nses f or at least 1 2 c o nsec uti ve m o nt hs wi t h n o alter nati ve pat h o l ogi cal or 
p h ysi o l ogical ca use; stat us ma y be c o nfir me d b y ha vi n g a ser u m fol licle-
sti m ulati n g h or m o ne ( F S H) le vel c o nfir mi n g t he p ost-me n o pa usal state;  
b.
Ha ve u n der g o ne a d oc u me nte d h ysterect o m y a n d/ or bilateral o o p h orect o m y;
c.
Ha ve me dicall y c o nfir me d o varia n fail ure.
All ot h er female s u bjects (i ncl u di n g fe males wi t h tu bal li gati ons) will be c o nsi dere d t o be of
c hil d beari n g p ote ntial.
4. 5
S cr e e n F ail ur e s
Scree n fail ures are defi ne d as s u bjects w h o c o nse nt t o p artici pate i n t he cli nical st u d y but ar e 
n ot s u bse q ue ntl y ra n d o mise d. T o e ns ure tra ns pare nt re p ortin g of scree n fail ure s u bjects, a 
mi ni mal set of scree n fail u r e i nfor m atio n will i ncl u de de m o gra p h y, scree n fail ure details (e. g., 
wi t hdra wal  of c o nse nt), eli gi bility cri t eria, a n d a n y serio us a d verse e ve nts ( S A Es). 
I n di vi d uals w h o d o n ot meet t he crit eria for p arti ci patio n i n t his st u d y  (scree n fail ure) ma y n ot 
be r e-scree ne d.
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
2 4- O ct- 2 0 1 7 0 8: 4 9: 0 5
 
2 0 8 3 9 7 Cli ni c al Pr ot o c ol 2. d o c x
el d o _ c o ntr oll e d
2. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d b 1 b 9 1
Pa ge 2 0 of 6 2

S o di u m -calci u m mi xe d partial salt of p ol y( met h yl vi n y let her/ maleic aci d) a n d car b o x y met h ylcell ul ose
2 0 8 3 9 7
Fi nal Cli nica l Pr ot oc ol, 2 0 Oct 2 0 1 7
Gla x o S mit h Kli ne C o ns u mer Healt hcare C o nfi de ntial
Te m plate Ver si o n Effecti ve: 2 2-J u n-2 0 1 7
Pa ge 2 1 of  6 2
4. 6
S p o n s or’ s Q u alifi e d M e di c al P er s o n n el
T he c o ntact i nf or mat i on f or t he s p o ns or's a p pr o priatel y q ualifie d me dical/ de ntal pers o n nel f or 
t he st u d y is d oc u me nte d i n t he st u d y c o ntact list locate d i n t he St u d y  File.
T he c o ntact n u m ber ca n be use d b y i n vesti gati onal staff if t he y are see ki n g a d vice o n 
me dical/ de ntal q uest i ons or pr o ble ms; h o we ver, it s h o ul d be use d o nl y i n t he e ve nt t hat t he 
esta blis he d c o m m u nicati o n pat h wa ys bet wee n t he i n vesti gati onal sit e a n d t he st u d y tea m are 
n ot a vaila ble. 
It is t heref ore i nte n de d t o a u g me nt, b ut n ot  re place, t he esta blis he d 
c o m m u nicat i on pat h wa ys bet wee n t he i n vesti gati o nal sit e a n d t he st u d y tea m f or a d vice o n 
me dical/ de ntal q uest i ons or pr o bl e ms t hat ma y arise d uri n g t he st u d y. T he c o ntact n u m ber is 
n ot i nte n de d f or use b y t he s u bject direct l y, a n d if a s u bject calls t hat n u m ber, he or s he will 
be directe d bac k t o t he i n vesti gat i onal site.
T o facilitate access t o a p pr o priatel y q ualifie d me dical/ de ntal pers o n nel  on st u d y-r elate d 
me dical/ de ntal q uest i ons or pr o ble ms, s u bjects are pr o vi de d wi t h a co ntact car d. T he c o ntact 
car d c o ntai ns, at a mi ni m u m, pr ot oc ol  ide nt ifiers, s u bject st u d y nu m bers, c o ntact i nf or mati on 
f or t he i n vesti gati onal sit e, a n d c o ntact details i n t he e ve nt t hat t he i n vesti gati onal sit e staff
ca n n ot be reac he d t o pr o vi de a d vice o n a me d ical quest i on or pr o ble m i de ntifie d fr om t he 
s u bject’s healt hcare pr ofessi o n al  ot her t ha n t he i n vesti gat or.
5
S T U D Y T R E A T M E N T S
5. 1
Bli n di n g a n d All o c ati o n t o Tr e at m e nt/ R a n d o mi s ati o n
Treat me nts will be pr o vi de d i n a n o pe n -la bel ma n ner.  N o me m bers of t he st u d y  tea m will b e 
bli n d e d t o t h e tr e at m e nt allo c ati o n.  T h e i n vesti gat or’s k n o wle d g e of t h e tr e at me nt s h o uld n ot 
i nfl ue nce t he decisi o n  to e nr ol a part ic ular s u bject or affect t he or der i n w hic h s u bjects are 
e nr o lle d.
I n Ve nti v Heal t h will pr o vi d e a ra n d omisati o n sc he d ule t o t he st u d y site.  This c o nsists of  a 
series of  ra n d o misat i on n u m bers.  Eac h ra n d o misati on n u m ber lists 3 c orres p o n di n g 
alp ha bet ic treat me nt c o des, wi t h a uni q ue c o de assi g ne d f or eac h of  the 3 tr e at me nt  perio ds 
(e. g. treat me nt peri o d 1 = B, treat me nt peri o d 2 = A, treat me nt peri o d 3 = C).  The sc he d ule will 
als o detail w hic h tr e at me nt c o de c orres p o n ds t o eac h of  the 3 treat me nts detaile d i n S e cti o n 
5. 3 .  At Vi sit 2, eac h s u bject w h o f ulfils all t he i ncl usi o n crit eria a n d n o ne of  the e xcl usio n 
criteria will be assi g ne d t he l ow est a vaila ble ra n d omisat i on n u m ber (eac h ra n d omisat i on 
n u m ber s h o uld o nl y be assi g ne d t o a si n gle s u bject).  The se q ue nce of  treatme nt s f or eac h 
ra n d omise d s u bject ca n t heref ore be rea d fr om t he ra n d omisat i on sc he d ule f or t hat s u bject’s 
ra n d omisat i on n u m ber.  The c orres p o n di n g ra n d o misati on tr e at me nt c o de will als o be pri nte d 
o n t he s u p plie d pr o d uct a p plicat i on i nstr uctio n s heets f or t he tr e at me nts e xce pt f or t he “ n o 
a d hesi ve” tr e at me nt.  Specific trai ni n g o n t his pr oce d ure will be carrie d o ut at  the Si t e 
I nitiatio n Visi t.
S u bject recr ui t me nt will be c o ntr olle d t o e ns ure 5 0 ± 1 0 % of t he s u bjects will be i n e a c h of t he 
l ow a n d hi g h Ka p ur -Ols ha n gr o u ps [t he l ow Ka p ur -Ols ha n gr o u p is defi ne d as a c o m p osite 
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
2 4- O ct- 2 0 1 7 0 8: 4 9: 0 5
 
2 0 8 3 9 7 Cli ni c al Pr ot o c ol 2. d o c x
el d o _ c o ntr oll e d
2. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d b 1 b 9 1
Pa ge 2 1 of 6 2

S o di u m -calci u m mi xe d partial salt of p ol y( met h yl vi n y let her/ maleic aci d) a n d car b o x y met h ylcell ul ose
2 0 8 3 9 7
Fi nal Cli nica l Pr ot oc ol, 2 0 Oct 2 0 1 7
Gla x o S mit h Kli ne C o ns u mer Healt hcare C o nfi de ntial
Te m plate Ver si o n Effecti ve: 2 2-J u n-2 0 1 7
Pa ge 2 2 of  6 2
Ka p ur -Ols ha n sc ore of  6- 1 4 (cli nicall y fair a n d g o o d de nt ures) a n d t he hi g h Ka p ur -Ols ha n 
sc ore as 1 5-1 8 (cli nicall y ver y g o o d de nt ures)].
5. 2
S u bj e ct C o m pli a n c e
St u d y  tr e at me nt will be a d mi nistere d u n der t he s u per visi on of  in vest i gat or sit e pers o n nel a n d 
d oc u m e nte d i n t he C R F.
5. 3
I n v e sti g ati o n al Pr o d u ct S u p pli e s
T he f o ll owi n g st u d y  pr o d ucts will be s u p plie d b y t he Cli nical S u p plies De part me nt, G S K C H:
Test Pr o d uct 
( C o n ve nti o n al 
A p plic ati o n)
Test Pr o d uct 
( C o nti n u o us Stri ps 
A p plic ati o n)
Ne g ati ve C o ntr ol
Pr o d uct N a me 
S u per P oli gri p ® Free 
De nt ure A d hesi ve 
Crea m  ( U S A 
Mar ket place)
S u per P oli gri p ® Free 
De nt ure A d hesi ve Crea m 
( U S A Mar ket place)
N o A d hesi ve
Pr o d uct 
F or m ul ati o n 
C o de
N/ A
D ose
1. 6 g of a d hesi ve 
a p plie d as 1. 0 g f or 
ma xillar y  de nt ure a n d 
0. 6 g f or m a n di b ular 
de nt ure.
1. 6 g of a d hesi ve a p plie d 
as 1. 0 g f or ma xillar y 
de nt ure a n d 0. 6 g f or 
ma n di b ular de nt ure.
N/ A
R o ute of 
A d mi nistr ati o n
A p plie d t o de nt ure 
w hic h is place d i n 
m o ut h
A p plie d t o de nt ure w hic h 
is place d i n m o ut h
N/ A
D osi n g 
I nstr ucti o ns
As per t he Pr o d uct 
A p plicat i on I nstr ucti o ns
As per t he Pr o d uct 
A p plicat i on I nstr ucti o ns
N/ A
Ot her ite ms t o be s u p plie d b y t he Cli nical S u p plies De part me nt, G S K C H:

Or al  B® De nt ure br us he s - t o clea n de nt ures.

P oli de nt ® De nt u Crè me De nt ure clea nsi n g paste ( U S A mar ket place) - t o clea n 
de nt ures.

S y rin ges - t o a p pl y a d hesi ve t o de nt ures.

S y rin ge ca ps - t o pr otect pre-fille d s yri n ges.

Pre g na nc y test kits.
                                               
® P oli gri p is a re gistere d tra de mar k of Gla x o S mit h Kli ne C o ns u mer Healt hcare.
® Oral B is a re gistere d tra de mar k of Pr oct or & Ga m ble.
® P oli de nt De nt u Crè me is a re gistere d tra de mar k of Gla x o S mit h Kli ne C o ns u mer Healt hcare.
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
2 4- O ct- 2 0 1 7 0 8: 4 9: 0 5
 
2 0 8 3 9 7 Cli ni c al Pr ot o c ol 2. d o c x
el d o _ c o ntr oll e d
2. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d b 1 b 9 1
Pa ge 2 2 of 6 2
C CI
C CI

S o di u m -calci u m mi xe d partial salt of p ol y( met h yl vi n y let her/ maleic aci d) a n d car b o x y met h ylcell ul ose
2 0 8 3 9 7
Fi nal Cli nica l Pr ot oc ol, 2 0 Oct 2 0 1 7
Gla x o S mit h Kli ne C o ns u mer Healt hcare C o nfi de ntial
Te m plate Ver si o n Effecti ve: 2 2-J u n-2 0 1 7
Pa ge 2 3 of  6 2
5. 3. 1
D o s a g e F or m a n d P a c k a gi n g
T he t est pr o d uct is i nte n de d f or or al  use, a n d will be a d mi nistere d orall y as detaile d i n t he 
Pr o d uct A p plicat i on I nstr uctio ns .  The t est pr o d uct will 
be s u p plie d b y G S K C H i n 
c o m merciall y mar kete d t u bes s o urce d fr om t he U S A mar ket place.  The c o nte nts of  the 
pr o d uct l a bel will be i n acc or da nce wit h all a p plica ble re g ulat or y re q uire me nts a n d will be t he 
res p o nsi bility of t he Gl o bal Cli nical S u p plies De part me nt, G S K C H.
All s u n dr y it e ms will be s u p plie d i n t heir c o m mercial pac ka gi n g f or use b y st u d y staff as 
re q uire d.
Care s h o ul d be ta ke n wi t h t he s u p plie d pr o d ucts a n d t heir la bels s o t hat t he y are mai ntai ne d i n 
g o o d c o n dit i on. It is i m p orta nt t hat all la bels re mai n i ntact a n d le gi ble f or t he d urat i on of  t he 
st u d y.
5. 3. 2
Pr e p ar ati o n a n d Di s p e n si n g 
T o e ns ure c o nsiste nc y of  treat me nt pr o d uct, p ri or t o t he first use of  eac h t u be of de nt ure 
a d hesi ve, t he first 1 - 2 i nc hes of  ad hesi ve s hall be e xtr u de d a n d di s p ose d.  S u p plie d s yri n ges 
will be fille d b y t he sit e pers o n nel s o t hat t he y c o ntai n 1. 0 0 ± 0. 0 5 g or 0. 6 0 ± 0. 0 5 g of  test 
de nt ure a d hesi ve f or a p plicat i on t o t he ma xillar y  an d ma n di b ular de nt ures res pecti vel y.  
S y rin ges ca n be pre -fille d i n a d va nce of  the a p plicati o n, b ut m u st be st ore d ca p pe d a n d m ust 
n ot b e st or e d f or l o n ger t ha n 4 h o urs after l oa di n g.  T he mass of a d hesi ve i n eac h s yrin ge, t he 
ti me of  loa di n g a n d t he time t he de nt ures are place d i n t he m o ut h will be rec or de d i n a 
di s pe nsi n g l og a n d t he C R F.  Syr i n ges will be la belle d wi t h t he s u bject or ra n d o misati on 
n u m ber a n d i de nt if yi n g te xt f or ma xillar y or ma n di b ular a p plicati o n.
5. 4
A d mi ni str ati o n
S u bject’s de nt ures will first be clea ne d pri or t o a p plicat i on of a d hesi ve, or n o a d hesi ve.  Usi n g 
t he s u p plie d de nt ure b r us h a n d clea nsi n g paste, b ot h t he u p per a n d l ower de nt ures will be 
t hor o u g hl y clea ne d t o re m o ve all traces of  de nt ure fi xati ve, pla q ue a n d partic ulates/ de bris.  
De nt ures s h o ul d t he n be drie d.
A d hesi ve is a p plie d t o de nt ures b y e xtr u di n g all of  the pre -wei g he d a d hesi ve fr om s yri n ges 
o nt o t he de nt ures per t he Pr o d uct A p plicat i on I nstr ucti o ns .  T he de nt ures will t he n be ret ur ne d 
t o t he s u bject w h o s h o uld r e p osi tio n t he de nt ures i n t hei r m o ut h a n d bit e d o w n t o sec ure h old.  
F or s u bjects o n t he “ n o a d hesi ve” treat me nt visit, t he de nt ures s h o uld be clea ne d a n d drie d as 
a b o ve, t he n refitte d b y t he s u bject.
5. 4. 1
M e di c ati o n Err or s
Me dicat i on err ors ma y res ult, i n t his st u d y , fr o m t he a d mi nistratio n or c o ns u m pti o n o f: 

t he wr o n g pr o d uct,

b y t he wr o n g s u bject, 

at t he wr o n g ti me, 
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
2 4- O ct- 2 0 1 7 0 8: 4 9: 0 5
 
2 0 8 3 9 7 Cli ni c al Pr ot o c ol 2. d o c x
el d o _ c o ntr oll e d
2. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d b 1 b 9 1
Pa ge 2 3 of 6 2

S o di u m -calci u m mi xe d partial salt of p ol y( met h yl vi n y let her/ maleic aci d) a n d car b o x y met h ylcell ul ose
2 0 8 3 9 7
Fi nal Cli nica l Pr ot oc ol, 2 0 Oct 2 0 1 7
Gla x o S mit h Kli ne C o ns u mer Healt hcare C o nfi de ntial
Te m plate Ver si o n Effecti ve: 2 2-J u n-2 0 1 7
Pa ge 2 4 of  6 2

or at t he wr o n g d osa ge a m o u nt ( ot her e xa m ples of c o ncer n ma y be a d de d base d o n 
t he i n vest i gati onal pr o d uct a d mi nistrati o n, s uc h as i na d verte nt e x p os ure).  
S uc h me dicat i on err ors occ urri n g t o a st u d y partici pa nt are t o be ca pt ure d i n t he C R F.  In t he 
e ve nt of me dicat i on d osi n g err or, t he s p o ns or s h o ul d be n otifie d i m me diatel y .
Me dicat i on err ors are re p orta ble irres pecti ve of t he prese nce of  an ass ociate d A E/ S A E, 
i ncl u di n g:

Me dicat i on err ors i n v o l vi n g s u bject e x p os ure t o t he i n vesti gati onal pr o d uct;

P ote nti al me dicat i on err ors or uses o utsi de of  what is f oresee n i n t he pr ot oc ol  t hat 
d o or d o n ot i n v o l ve t he partici pati n g s u bject.
W het her 
or n ot a me d icatio n err or is acc o m p a nie d b y a n A E, as deter mi ne d b y t he 
i n vesti gat or, t he me d icati on err or a n d, if a p plica ble, a n y ass ociate d a d verse e ve nt(s) is 
ca pt ure d o n a n a d verse e ve nt ( A E) C R F pa ge.
5. 5
I n v e sti g ati o n al Pr o d u ct St or a g e
T he i n vesti gat or, or a n a p pr o ve d re prese ntati ve will e ns ure t hat all i n vesti gati onal pr o d ucts 
are store d i n a sec ure d area wi t h co ntr olle d access u n der re q uire d st ora ge c o n dit i ons a n d i n 
acc or da nce wit h a p plica ble re g ulat or y re q uire me nts a n d pr o d uct la bel.  
Si t e s yste ms m ust be ca pa ble of  meas uri n g a n d d oc u m e nt i n g (for e xa m ple, via a l og), at a 
mi ni m u m, dail y mi ni m u m a n d ma xi m u m t e mperat ures f or all sit e st ora ge l ocatio ns (as 
a p plica ble, i ncl u di n g fr oze n, refri gerate d, a n d/ or r o o m-t e mperat ure pr o d ucts).  T hi s s h o uld be 
ca pt ure d fr o m t he time of  in vest i gati onal pr o d uct recei pt t hr o u g h o ut t he st u d y.  Eve n f or 
c o nti n u o us m o nit ori n g s yste ms, a l o g or si te pr oce d ure t hat e ns ures acti ve dail y e val uati o n f or 
e xc ursi o ns s h o uld be a vaila ble.  The o perati o n of  the t e mpe rat ure-m o nit ori n g de vice a n d 
st ora ge u nit (f or e xa m ple, r efrigerat or), as a p plica ble, s h o uld be re g ularl y i ns pecte d t o e ns ure 
it is mai ntai ne d i n w or ki n g or der. 
A n y e xc ursi o ns fr o m t he pr o d uct -label st ora ge c o n dit i ons s h o uld be re p orte d u p o n disc o ver y.  
T he sit e s h o uld acti vel y purs ue o pti o ns f or ret ur ni n g t he pr o d uct t o t he st ora ge c o n ditio ns as 
descri be d i n t he la belli n g, as s o o n as p ossi ble.  De viat i ons fr om t he st ora ge re q uire me nts, 
i ncl u di n g a n y acti ons ta ke n, m ust be d oc u me nte d a n d re p orte d t o t he S p o ns or.  
O nce a n e xc ursio n is i de ntifie d, t he i n vesti gati onal pr o d uct m ust be q uara nt i ne d a n d n ot use d 
u nt il t he S p o ns or pr o vid es d o c u m e ntatio n of  per missio n  t o us e t h e i n v estigat i onal pr o d u ct.  It 
will 
n ot be c o nsi dere d a pr ot oc ol de viat i on if t he s p o ns or a p pr o ves t he use of  the 
i n vesti gati onal pr o d uct aft er t he t e mperat ure e xc ursi o n.
Use of  the i n vesti gati o nal pr o d uct 
pri or t o s p o ns or a p pr o val will be c o nsi dere d a pr ot oc ol  de viat i on.  Specific details re gar di n g 
i nf or mat i on t he site s h o ul d re p ort f or eac h e xc ursi o n will be pr o vi de d t o t he site. 
5. 6
I n v e sti g ati o n al Pr o d u ct A c c o u nt a bilit y
All pr o d ucts s u p plie d are f or use o nl y i n t his cli nical st u d y an d s h o uld n ot be use d f or a n y 
ot her p ur p ose.
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
2 4- O ct- 2 0 1 7 0 8: 4 9: 0 5
 
2 0 8 3 9 7 Cli ni c al Pr ot o c ol 2. d o c x
el d o _ c o ntr oll e d
2. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d b 1 b 9 1
Pa ge 2 4 of 6 2

S o di u m -calci u m mi xe d partial salt of p ol y( met h yl vi n y let her/ maleic aci d) a n d car b o x y met h ylcell ul ose
2 0 8 3 9 7
Fi nal Cli nica l Pr ot oc ol, 2 0 Oct 2 0 1 7
Gla x o S mit h Kli ne C o ns u mer Healt hcare C o nfi de ntial
Te m plate Ver si o n Effecti ve: 2 2-J u n-2 0 1 7
Pa ge 2 5 of  6 2
St u d y  treat me nts m u st be recei ve d b y a desi g nate d pers o n at t he st u d y sites, ha n dle d a n d 
st ore d safel y a n d pr o perl y, a n d ke pt i n a sec ure d l ocatio n t o w hic h o nl y t he staff ha ve access. 
U p o n receipt, all st u d y treat me nts s h o uld be st ore d acc or di n g t o t he i nstr ucti o ns s pecifie d o n 
t he treat me nt la bels. Cli nical s u p plies are t o be dis pe nse d o nl y i n acc or da nce wi t h the 
pr ot oc ol .
T he cli nical st u d y site m ust ma i ntai n a de q uate rec or ds d oc u m e nt i n g t he recei pt, use, l oss, or 
ot her di s p ositio n of  t he i n vestigat i onal pr o d uct s u p plies.  All st u d y  pr o d ucts will be acc o u nte d 
f or usin g a dr u g acc o u nta bilit y f or m/rec or d. 
T he i n ve nt or y must be a vaila ble f or i ns pecti on b y t he st u d y mo ni t or d uri n g t he st u d y. 
M o ni t ori n g of  treat me nts acc o u nta bilit y will  be perf or m e d b y t he fiel d m o nit or d uri n g sit e 
visit s a n d at t he c o m pleti on of t he st u d y.
5. 6. 1
D e str u cti o n of I n v e sti g ati o n al Pr o d u ct S u p pli e s 
All i n vesti gati onal st u d y treat me nts s hi p pe d f or t his cli nical trial will be ret ur ne d t o t he 
S p o ns or at t he ter mi nati o n of  the st u d y.  At t he c o ncl usio n of  the st u d y, t he Pri nci pal 
I n vesti gat or or a n a p pr o priate desi g nee, a n d a re prese ntati ve of  GS K  CH will  in ve nt or y  all 
use d a n d u n use d i n vesti gati onal st u d y treat me nt.  The st u d y treat me nt i n ve nt or y rec or d f or 
ret ur ne d st u d y treat me nt will t he n be c o m p lete d. All i n vesti gati o nal pr o d uct f or t his cli nical 
stu d y (e m pty c o ntai ners), as well as all u n use d st u d y pr o d uct will be ret ur ne d t o t he 
desi g nate d ve n d or usi n g t he ret ur n s hi p pi n g i nstr ucti o ns pr o vi de d. 
5. 7
C o n c o mit a nt Tr e at m e nt s
Details of  an y rele va nt de ntal , me dical or s ur gical hist or y ( wit hi n t he last year ), i ncl u di n g 
aller gies or dr u g se nsit i vity, will be rec or de d i n t he C R F.  T he use of c o nc o mita nt me dicat i ons 
is per mi tt e d i n t his st u d y with t he e xce pt i on of  the use of  bis p h os p h o nate dr u gs (e xcl usi o n 
crit erio n 9) a n d me dicat i ons t hat i n t he o pi ni o n  of t he i n vesti gat or w o ul d i nterfere wi t h the 
c o n d uct of t his st u d y (e xcl usio n  crit erio n 1 5).
Treat me nts ta ke n aft er t he first d ose of  st u d y in vesti g ati o nal pr o d uct will be d o c u m e nte d as 
c o nc o mita nt treat me nts.
All c o nc o mit a nt treat me nts ta ke n d uri n g t he st u d y mu st be rec or de d wi t h in dicat i on, u ni t 
d ose, dail y d ose, a n d start a n d st o p dates of  ad mi nistrati o n.  All s u bjects will be q uest i one d 
a b o ut c o nc o mita nt treat me nt at eac h cli nic visit.
S u bjects will be as ke d n ot t o ha ve a n y n o n- e mer ge nc y de ntal / de nt ure w or k p erf or me d d uri n g 
t he ti me t he y are i n t he st u d y, u nless disc usse d a n d per mitte d b y t he e xa mi ner.  This is t o 
ass ure t hat t he de nt ure fit will n ot be altere d d uri n g t he st u d y.
5. 8
R e s c u e M e di c ati o n 
N o s pecific resc ue t hera p y is re q uire d i n t his st u d y.  Sh o ul d a s u bject s uffer a n a d verse 
reactio n t o t he pea n uts c o ns u me d i n t his st u d y t he n t h e st u d y staff will a d mi nister a p pr o priate 
first aid i ncl u di n g use of a dre nali ne i n t he case of a na p h yla xis.
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
2 4- O ct- 2 0 1 7 0 8: 4 9: 0 5
 
2 0 8 3 9 7 Cli ni c al Pr ot o c ol 2. d o c x
el d o _ c o ntr oll e d
2. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d b 1 b 9 1
Pa ge 2 5 of 6 2

S o di u m -calci u m mi xe d partial salt of p ol y( met h yl vi n y let her/ maleic aci d) a n d car b o x y met h ylcell ul ose
2 0 8 3 9 7
Fi nal Cli nica l Pr ot oc ol, 2 0 Oct 2 0 1 7
Gla x o S mit h Kli ne C o ns u mer Healt hcare C o nfi de ntial
Te m plate Ver si o n Effecti ve: 2 2-J u n-2 0 1 7
Pa ge 2 6 of  6 2
6
S T U D Y P R O C E D U R E S
6. 1
S T U D Y P E RI O D
6. 1. 1
S cr e e ni n g - Vi sit 1
T he f oll owi n g pr o ce d ures/assess me nts will ta ke pl ace i n t he or der liste d bel o w ( w here 
p ossi ble), a n d rec or de d i n t he C R F:

O btai n writte n i nf or me d c o nse nt.  

C ollect de m o gra p h y  ( year of birt h, ge n der, race a n d et h nicity) .

O btai n me dical hist or y , i ncl u di n g hist or y of ille gal dr u g, alc o h o l a n d t o bacc o use.

O btai n De ntal  Hist or y.

O btai n c o m p lete me d icati on hist or y of  all prescripti o n or n o n -prescri pt i on dr u gs, a n d 
di et ar y a n d her bal s u p ple me nts ta ke n wit hi n 3 0 da ys pri or t o t he pla n ne d first d ose.

Perf or m  O S T E xa mi nat i on- E de nt ul o us .

Cl ea n t he s u bject’s de nt ures usi n g t he s u p plie d de nt ure br us h a n d clea nsi n g paste, 
b ot h t he u p per a n d l ower de nt ures will b e t hor o u g hl y clea ne d t o r e mo ve all traces of  
de nt ure fi xat i ve, pla q ue a n d partic ulates/ de bris. De nt ures s h o ul d t he n be drie d.

Perf or m  t he Well -Ma de Assess me nt .

Perf or m  t he Well -Fi t Assess me nt.

Perf or m  t he F o o d Mi grati o n A de q uac y Assess me nt .

Re vie w I ncl usi o n a n d E xcl usi o n cri t eria.  Pre g na nc y stat us will be c o nfir me d ver ball y 
b y t he s u bject.

Assess s u bject eli gi bilit y.

A n y seri o us a d verse e ve nt assesse d as relate d t o st u d y partici pat i on t hat occ urs 
s u bse q ue nt t o t he si g ni n g of i nf or me d c o nse nt will be rec or de d.
T o pre pare f or st u d y parti ci pat i on, s u bjects will be i nstr ucte d o n t he use of  the Lifest yle 
G ui deli ne s a n d C o nc o mit a nt Treat me nt(s) secti o ns of t he pr ot oc ol.
6. 1. 2
Vi sit 2
S u bjects will be a d mitt e d t o t he cli nical sit e bet wee n 2 - 3 0 d a y s aft er Scree ni n g.  The 
f oll owi n g pr oce d ures will be c o m p lete d i n t he f oll owi n g or der ( w here ver p o ssi ble) a n d 
rec or de d i n t he C R F:

Re vie w I ncl usi o n a n d E xcl usi o n cri t eria.  Pre g na nc y stat us will be c o nfir me d ver ball y 
b y t he s u bject.

C ollect uri ne pre g na nc y test f or fe males of c hil d beari n g p ote ntial. 

C o nfir m pr o per c o ntrace pti o n is bei n g use d.

Re vie w c ha n ges i n t he s u bject’s me dical hist or y  incl u di n g me dicat i on hist or y  si nce 
Scree ni n g.

Perf or m  O S T E xa mi nat i on- E de nt ul o us .
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
2 4- O ct- 2 0 1 7 0 8: 4 9: 0 5
 
2 0 8 3 9 7 Cli ni c al Pr ot o c ol 2. d o c x
el d o _ c o ntr oll e d
2. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d b 1 b 9 1
Pa ge 2 6 of 6 2

S o di u m -calci u m mi xe d partial salt of p ol y( met h yl vi n y let her/ maleic aci d) a n d car b o x y met h ylcell ul ose
2 0 8 3 9 7
Fi nal Cli nica l Pr ot oc ol, 2 0 Oct 2 0 1 7
Gla x o S mit h Kli ne C o ns u mer Healt hcare C o nfi de ntial
Te m plate Ver si o n Effecti ve: 2 2-J u n-2 0 1 7
Pa ge 2 7 of  6 2

Assess s u bject eli gi bilit y.

Ra n d o mise s u bject t o treat me nt gr o u p.

Cl ea n t he s u bject’s de nt ures usi n g t he s u p plie d de nt ure br us h a n d clea nsi n g paste, 
b ot h t he u p per a n d l ower de nt ures will b e t hor o u g hl y clea ne d t o r e mo ve all traces of  
de nt ure fi xat i ve, pla q ue a n d partic ulates/ de bris. De nt ures s h o ul d t he n be drie d.

A p pl y treat me nt a n d i nsert de nt ures per t he Pr o d uct A p plicati o n I nstr ucti o ns .

6 0 ± 5 mi n utes 
aft er de nt ure i nserti o n, be gi n F o o d Occl usi o n Test i n g i ncl u di n g 
De nt ure Di slo d ge me nt Assess me nt .

Rec or d t he n u m ber of de nt ure disl o d ge me nts d uri n g pea n ut c he wi n g.

S u bjects c o m plete t he q uesti o n naire.

P h ot o gra p h de nt ures f or a s u bset of s u bjects.

Perf or m  O S T E xa mi nat i on- E de nt ul o us .

Ret ur n cl ea n de nt ures t o s u bject.

Rec or d A Es a n d i nci de nts. Assess s y m pt o ms b y s p o nta ne o us re p orti n g of  ad verse 
e ve nts a n d b y as ki n g t he s u bjects t o res p o n d t o a n o n- lea di n g q uest i on s uc h as “ H o w 
d o y o u feel?”  A n y a d verse e ve nt t hat occ urs s u bse q ue nt t o t he first d ose will be
rec or de d.
6. 1. 3
Vi sit 3
S u bjects will be a d mitt e d t o t he cli nical sit e bet wee n 2 - 3 0 da ys aft er Visi t 2.  The f oll owi n g 
pr oce d ures will be c o m p lete d i n t he f oll o wi n g or der ( w here ver p ossi ble) a n d rec or de d i n t he 
C R F:

Re vie w I ncl usi o n a n d E xcl usi o n cri t eria.  Preg na nc y  stat us will be c o nfir me d ver ball y 
b y t he s u bject.

C ollect uri ne pre g na nc y t est f or fe males of  chil d beari n g p ote nti al if re q uire d per 
Secti o n 7. 3. 2 .

Re vie w c ha n ges i n t he s u bject’s me dical hist or y  incl u di n g me dicat i on hist or y  si nce 
Scree ni n g.

Perf or m  O S T E xa mi nat i on- E de nt ul o us .

Assess s u bject eli gi bilit y.

Cl ea n t he s u bject’s de nt ures usi n g t he s u p plie d de nt ure br us h a n d clea nsi n g paste, 
b ot h t he u p per a n d l ower de nt ures will b e t hor o u g hl y clea ne d t o r e mo ve all traces of  
de nt ure fi xat i ve, pla q ue a n d partic ulates/ de bris. De nt ures s h o ul d t he n be drie d.

A p pl y treat me nt a n d i nsert de nt ures per t he Pr o d uct A p plicati o n I nstr ucti o ns .

6 0 ± 5 mi n utes 
aft er de nt ure i nserti o n, be gi n F o o d Occl usi o n Test i n g i ncl u di n g 
De nt ure Di slo d ge me nt Assess me nt .

Rec or d t he n u m ber of de nt ure disl o d ge me nts d uri n g pea n ut c he wi n g.

S u bjects c o m plete t he q uesti o n nair e.

P h ot o gra p h de nt ures f or a s u bset of s u bjects.
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
2 4- O ct- 2 0 1 7 0 8: 4 9: 0 5
 
2 0 8 3 9 7 Cli ni c al Pr ot o c ol 2. d o c x
el d o _ c o ntr oll e d
2. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d b 1 b 9 1
Pa ge 2 7 of 6 2

S o di u m -calci u m mi xe d partial salt of p ol y( met h yl vi n y let her/ maleic aci d) a n d car b o x y met h ylcell ul ose
2 0 8 3 9 7
Fi nal Cli nica l Pr ot oc ol, 2 0 Oct 2 0 1 7
Gla x o S mit h Kli ne C o ns u mer Healt hcare C o nfi de ntial
Te m plate Ver si o n Effecti ve: 2 2-J u n-2 0 1 7
Pa ge 2 8 of  6 2

Perf or m  O S T E xa mi nat i on- E de nt ul o us .

Ret ur n cl ea n de nt ures t o s u bject.

Rec or d A Es a n d i nci de nts. Assess s y m pt o ms b y s p o nta ne o us re p orti n g of  ad verse 
e ve nts a n d b y as ki n g t he s u bjects t o res p o n d t o a n o n-lea di n g q uest i on s uc h as “ H o w 
d o y o u f eel?”
6. 1. 4
Vi sit 4
S u bjects will be a d mitt e d t o t he cli nical sit e bet wee n 2 - 3 0 da ys aft er Visi t 3.  The f oll owi n g 
pr oce d ures will be c o m p lete d i n t he f oll o wi n g or der ( w here ver p ossi ble) a n d rec or de d i n t he 
C R F:

Re vie w I ncl usi o n a n d E xcl usi o n cri t eria.  Pre g na nc y stat us will be c o nfi r me d ver ball y 
b y t he s u bject.

C ollect uri ne pre g na nc y t est f or females of c hil d beari n g p ote nti al if re q uir e d per 
Secti o n 7. 3. 2 .

Re vie w c ha n ges i n t he s u bject’s me dical hist or y i ncl u di n g me dicati o n hist or y si nce 
Scree ni n g.

Perf or m  O S T E xa mi nat i on- E de nt ul o us .

Assess s u bject eli gi bilit y.

Cl ea n t he s u bject ’s de nt ures usi n g t he s u p plie d de nt ure br us h a n d clea nsi n g paste, b ot h 
t he u p per a n d l ower de nt ures will be t hor o u g hl y clea ne d t o re m o ve all traces of 
de nt ure fi xat i ve, pla q ue a n d partic ulates/ de bris. De nt ures s h o ul d t he n be drie d.

A p pl y treat me nt a n d i nse rt de nt ures per t he Pr o d uct A p plicati o n I nstr ucti o ns .

6 0 ± 5 mi n utes after de nt ure i nserti o n, be gi n F o o d Occl usi o n  Testi n g i ncl u di n g De nt ure 
Di slo d ge me nt Assess me nt .

Rec or d t he n u m ber of de nt ure disl o d ge me nts d uri n g pea n ut c he wi n g.

S u bjects c o m plete t he q uesti o n naire.

P h ot o gra p h de nt ures f or a s u bset of s u bjects.

Perf or m  O S T E xa mi nat i on- E de nt ul o us .

Ret ur n cl ea n de nt ures t o s u bject .

Rec or d A Es a n d i nci de nts. Assess s y m pt o ms b y s p o nta ne o us re p orti n g of a d verse 
e ve nts a n d b y as ki n g t he s u bjects t o res p o n d t o a n o n- lea di n g q uest i on s uc h as “ H o w 
d o y o u f eel?”

St u d y  c o nclusi o n .
If a s u bject has a n y cli nicall y si g nifica nt, st u d y-r elate d a b n or malit ies at t he c o nclusi o n  of a 
sc he d ule d i n patient  porti o n of  the st u d y, t he G S K C H me dical 
m o nit or ( or desi g nate d 
re prese ntati ve) s h o ul d be n otifie d a n d de pe n di n g o n t he a b n or mality,  t he s u bject ma y be as ke d 
t o r e mai n at t he cli nical sit e u nt il s uc h a b n or malit ies are dee me d n ot cli nicall y si g nifica nt, or 
it is s afe f or o ut pati e nt f oll ow- u p.  If t he s u bject is u na ble or u n willi n g t o re mai n at t he 
cli nical sit e a n d/ or w he n o ut pati e nt f oll ow- u p is dee m e d a p pr o priate, t he G S K C H me dica l 
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
2 4- O ct- 2 0 1 7 0 8: 4 9: 0 5
 
2 0 8 3 9 7 Cli ni c al Pr ot o c ol 2. d o c x
el d o _ c o ntr oll e d
2. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d b 1 b 9 1
Pa ge 2 8 of 6 2

S o di u m -calci u m mi xe d partial salt of p ol y( met h yl vi n y let her/ maleic aci d) a n d car b o x y met h ylcell ul ose
2 0 8 3 9 7
Fi nal Cli nica l Pr ot oc ol, 2 0 Oct 2 0 1 7
Gla x o S mit h Kli ne C o ns u mer Healt hcare C o nfi de ntial
Te m plate Ver si o n Effecti ve: 2 2-J u n-2 0 1 7
Pa ge 2 9 of  6 2
m o nit or ( or d esi g n ate d re prese ntati ve) s h o uld b e s o n otifie d, a n d t he i n vestigat or s h o ul d ma ke 
e ver y effort t o arra n ge f oll ow- u p e val uat i ons at a p pr o priate i nter vals t o d oc u me nt t he c o urse 
of  t he a b n or malities.
6. 2
S u bj e ct Wit h dr a w al
At  the e n d of  the st u d y su bjects will be e va l uate d t o deter mi ne if t he y c o m p lete d all st u d y 
pr oce d ures or if t he y were disc o nt i n ue d fr om t he st u d y earl y. If t he s u bject di sc o nti n ue d at 
a n y p o i nt d uri n g t he st u d y, t he pri mar y reas o n f or wit h dra wal s h o ul d be rec or de d o n t he St u d y 
C o ncl usi o n  pa ge of t he C R F b y selecti n g o ne of t he o pti o ns bel o w.
1. S u bj ect did n ot m eet st u d y crit eria
2. A d verse e ve nt
3. S u bj ect lost t o f oll o w u p
4. Pr ot oc ol  Viol at i on
5. Wi t hdra wal  of inf or me d c o nse nt
6. Ot her
S u bjects ma y wi t hdra w fr om t he st u d y at a n y time at t heir o w n re q uest, or t he y ma y be 
wi t hdra w n at a n y time 
at t he di screti on of  the i n vesti gat or or s p o ns or f or safety or, 
be ha vi o ural reas o ns, or t he i na bility of  the s u bject t o c o mpl y wi t h the pr ot oc ol -re q uir e d 
sc he d ule of st u d y visits or pr oce d ures at a gi ve n st u d y sit e.  
T he f oll owi n g circ u msta nces re q uir e disc o nt i n uati o n of  st u d y treat me nt a n d/ or pre mat ure 
s u bject wit h dra wal:

Pr ot oc ol  viol at i on t hat m a y i m pact t he o utc o me of t he s u bject’s safety

Wit h dra wal o f i nf or me d c o nse nt

S u bject l ost t o f oll o w - u p 

Pre g na nc y

Deat h
If a s u bject is disc o nt i n ue d or pre mat urel y wi t hdra ws fr om 
t he st u d y, reas o ns f or 
di sc o nti n uati on or wi t hdra wal  an d ass ociate d date m ust be d oc u me nte d i n t he rele va nt 
secti on(s) of t he C R F. 
If a s u bject d oes n ot ret ur n f or a sc he d ule d visit, e ver y eff ort s h o ul d be ma de t o c o ntact t he 
s u bject.  T he I n vesti gat or or site staff s h o ul d atte m pt t o c o ntact t he s u bject t wice.  After t w o 
atte mpts, cli nical  site staff m ust se n d a re gistere d letter.  If n o res p o nse is recei ve d fr om t he 
s u bject, t he s u bject will be c o nsi dere d l ost t o f o ll ow u p.  All atte m pts t o c o ntact t he s u bject 
a n d i nf or mat i on recei ve d d uri n g c o ntact atte m pts m ust be d oc u me nte d i n t he C R F.  I n a n y 
circ u msta nce, e ver y effort s h o ul d b e m a de t o d oc u me nt s u bject o utc o me, if p ossi ble.  T he 
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
2 4- O ct- 2 0 1 7 0 8: 4 9: 0 5
 
2 0 8 3 9 7 Cli ni c al Pr ot o c ol 2. d o c x
el d o _ c o ntr oll e d
2. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d b 1 b 9 1
Pa ge 2 9 of 6 2

S o di u m -calci u m mi xe d partial salt of p ol y( met h yl vi n y let her/ maleic aci d) a n d car b o x y met h ylcell ul ose
2 0 8 3 9 7
Fi nal Cli nica l Pr ot oc ol, 2 0 Oct 2 0 1 7
Gla x o S mit h Kli ne C o ns u mer Healt hcare C o nfi de ntial
Te m plate Ver si o n Effecti ve: 2 2-J u n-2 0 1 7
Pa ge 3 0 of  6 2
i n vestigat or s h o ul d i n q uire a b o ut t he reas o n f or wit h dra wal, re q uest t hat t he s u bject ret ur n f or 
a fi nal visit, if a p plica ble, a n d f o ll ow- u p wi t h t he s u bject re gar di n g a n y u nres ol ve d A Es.
It ma y be a p pr o priate f or t he s u bject t o r et ur n t o t he cli nical site f or final safet y assess me nts. 
S u bjects s h o uld be q uest i one d re gar di n g t heir reas o n f or wit h dra wal.  An O S T e xa mi nat i on 
ma y be c o n d ucte d at t he i n vest i gat or’s discreti on.
Lac k of  co m plet i on of  all or a n y of  the earl y ter mi nati on pr oce d ures will n ot be vie we d as 
p r ot oc ol de viati ons s o l o n g as t he s u bject’s safet y was preser ve d.
If t he s u bject wi t hdra ws fr om t he st u d y an d als o wi t hdra ws c o nse nt f or discl o s ure of  fut ure 
i nf or mat i on, n o f urt her e val uat i ons s h o uld be p erf or m e d a n d n o a d ditio nal data s h o uld be 
c ollecte d.  The s p o ns or ma y retai n a n d c o nt i n ue t o use a n y data c ollecte d bef ore s uc h 
wi t hdra wal  of c o nse nt.
7
A S S E S S M E N T S
E ver y  eff ort s h o uld be ma de t o e ns ure t hat pr ot oc ol -re q uire d tests a n d pr oce d ures are 
c o mplete d as descri be d.  Ho we ver, it is a nticipate d t hat fr o m ti me t o ti me t here ma y b e 
circ u msta nces, o utsi de t he c o ntr ol of t he i n vesti gat or t hat ma y ma ke it unfeasi ble t o perf or m 
t he t est.  I n t h es e c as es, t h e i n vesti gat or m ust ta ke all ste ps necessar y t o e ns ure t he safet y  a nd 
well -bei n g of  the s u bject.  
Whe n a pr ot oc ol -re q uire d t est ca n n ot be p erf or m e d, t he 
i n vesti gat or will d oc u me nt t he reas o n f or t he misse d t est a n d a n y c orrecti ve a n d pre ve ntati v e 
actio ns t hat he or s he has ta ke n t o e ns ure t hat re q uire d pr ocesses are a d here d t o as s o o n as 
p ossi ble.   T he s u bject s h o uld c o nt i n ue i n t he st u d y as l on g as t he safety of  the s u bject is n ot 
c o mpr o mise d   T he st u d y  tea m must be i nf or me d of t hese i nci de nts i n a ti mel y ma n ner.   
7. 1
S cr e e ni n g
T he f o ll owi n g assess me nts will be perf or m e d at ti mes defi ne d i n t he St u d y  Pr oce d ures secti o n 
of  t his pr ot oc ol.
7. 1. 1
I nf or m e d C o n s e nt
T he i n vesti gat or, or desi g nee, m u st o btai n wri tte n (sig ne d a n d date d b y t he s u bject) i nf or me d 
c o nse nt fr o m eac h s u bject parti ci pat i n g i n t his st u d y after a de q uate e x pla nati o n of t he ai ms, 
met h o ds, o bj ect i ves, a n d p ot e nti al hazar ds of  the st u d y. T he i n vesti gat or, or desi g nee, m ust 
als o e x plai n t o t he s u bjects t hat t he y are c o mpletel y  free t o ref use t o e nter t he stu d y or t o 
wi t hdra w fr om it  at a n y time. A p pr o pri ate f or ms f or d oc u m e nt in g a wri tte n c o nse nt will b e 
pr o vi de d b y t he i n vesti gat or or b y G S K C H. T he i n vesti gat or, or desi g nee, s h o uld si g n a n d 
date t he c o nse nt f or m to c o nfir m t hat t he c o nse nt pr ocess was c o m p lete d c orrectl y. T he 
s u bject, will be pr o vi de d wi t h a co p y  of t heir si gne d a n d date d c o nse nt f or m an d a n y ot h er 
wri tte n i nf or mati o n w hic h t he y s h o uld be i nstr ucte d t o retai n.  If, duri n g a s u bject’s 
parti ci pat i on i n t he st u d y, a n y ne w i nf or mati on bec o me s a vaila ble t hat ma y affect t he 
s u bject’s willi n g ness t o partici pate i n t he st u d y, eac h o n g oi n g s u bject s h o uld recei ve a c o p y  of 
t his ne w i nf or mati on a n d be r e-c o nse nte d i nto t he st u d y. S u bjects will be pr o vi de d wi t h a 
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
2 4- O ct- 2 0 1 7 0 8: 4 9: 0 5
 
2 0 8 3 9 7 Cli ni c al Pr ot o c ol 2. d o c x
el d o _ c o ntr oll e d
2. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d b 1 b 9 1
Pa ge 3 0 of 6 2

S o di u m -calci u m mi xe d partial salt of p ol y( met h yl vi n y let her/ maleic aci d) a n d car b o x y met h ylcell ul ose
2 0 8 3 9 7
Fi nal Cli nica l Pr ot oc ol, 2 0 Oct 2 0 1 7
Gla x o S mit h Kli ne C o ns u mer Healt hcare C o nfi de ntial
Te m plate Ver si o n Effecti ve: 2 2-J u n-2 0 1 7
Pa ge 3 1 of  6 2
c o p y of t he si g ne d a n d date d a me n de d c o nse nt f or m. T h e d at e of co nse nt will be rec or de d o n 
t he C R F.
7. 1. 2
D e nt al Hi st or y
T he I n vest i gat or, or me dicall y q ualifie d desi g nee, will ta ke a de ntal hist or y fr o m eac h s u bject.  
De ntal  hist or y will i ncl u de i nf or mati o n of  all pr ost heses i n t he m o ut h, ma xillar y 
a n d 
ma n di b ular y , as well as i nf or mati o n re gar di n g t he a ge of  the de nt ures, h o w l on g t he s u bject 
has w or n de nt ures, t he pr ost heti c teet h mat erial an d w het her t he s u bject is a re g ular user of  
de nt ure a d hesi ves. 
7. 1. 3
W ell -Fit A s s e s s m e nt, K a p ur ( Ol s h a n M o difi c ati o n) I n d e x
Eac h de nt ure ( u p per a n d l ower) will be e xa mi ne d f or rete nti o n a n d sta bilit y usi n g t he Ka p ur 
I n de x ( Ols ha n M o dificat i on) (Ka p ur, 1 9 6 7 ; Ols ha n, 1 9 9 2 ) b y a n e xa mi ner wi t h ex pert 
k n o wl e d ge of pr ost h o d o ntics.  A s u m sc ore ( u p per + l o wer) of ≥ 6 is re q uire d f or i ncl usi o n.
Rete nti o n:
Wit h gl o v e d ha n ds, t he e xa mi ner will att e mpt t o u n seat t he u p per a n d l ower de nt ure b y 
a p pl yi n g a n o p p osi n g verti cal f orce at t he ca ni ne/lateral i ncis or r e gio n of  the de nt ure.  The 
e xa mi ner will sc ore rete nti o n as 0 - 5 usi n g t he f o ll owi n g cri t eria:
5 = E xcelle nt - de nt ure offers e xcelle nt resista nce t o vert ical p ull a n d lateral f orce.
4 = Ver y  G o o d- de nt ure offers ver y g o o d resista nce t o vertical p ull a n d lateral f orce. 
3 = G o o d - de nt ure offers m o derate resista nce t o vertical p ull a n d lateral f orce.
2 = Fair - de nt ure offers m o derate resi sta nce t o vertical p ull a n d little or n o resista nce t o lateral 
f orces. 
1 = P o or - de nt ure offers sli g ht resista nce t o vertical p ull a n d little or n o resista nce t o lateral 
f orce.
0 = N o rete nti o n- w he n t he de nt ure is seate d i n place, it dis places itself. 
St a bility:
Wit h gl o v e d ha n ds, t he e xa mi ner will att e mpt t o r oc k t he seate d de nt ures b y placi n g al ter nate 
h ori z o nt al force at t he c us pi d a n d c o ntral ateral mol ar re gio n s of t he u p per a n d lo wer de nt ures.  
T he e xa mi ner will sc ore de nt ure st a bilit y as 0 - 4 usi n g t he f o ll owi n g cri t eria:
4 = E xcelle nt - w he n de nt ure base offers n o r oc ki n g o n its s u p p orti n g str uct ures u n der press ure.
3 = G o o d - w he n de nt ure base has ver y sli g ht r oc ki n g o n its s u p p orti n g str uct ures u n der 
press ure.
2 = Fair - w he n de nt ure base has sli g ht r oc ki n g o n its s u p p orti n g str uct ures u n der press ure.
1 = P o or - w he n de nt ure base has m o derate r oc ki n g o n its s u p p orti n g str uct ures u n der press ure.
0 = N o sta bilit y- w he n de nt ure base has e xtre me r oc ki n g u n der press ure.
S u m sc ore ( u p per + l o wer de nt ure) of < 6 = de nt ures wit h p o or rete nti o n a n d sta bilit y.
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
2 4- O ct- 2 0 1 7 0 8: 4 9: 0 5
 
2 0 8 3 9 7 Cli ni c al Pr ot o c ol 2. d o c x
el d o _ c o ntr oll e d
2. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d b 1 b 9 1
Pa ge 3 1 of 6 2

S o di u m -calci u m mi xe d partial salt of p ol y( met h yl vi n y let her/ maleic aci d) a n d car b o x y met h ylcell ul ose
2 0 8 3 9 7
Fi nal Cli nica l Pr ot oc ol, 2 0 Oct 2 0 1 7
Gla x o S mit h Kli ne C o ns u mer Healt hcare C o nfi de ntial
Te m plate Ver si o n Effecti ve: 2 2-J u n-2 0 1 7
Pa ge 3 2 of  6 2
S u m  sc ore ( u p per + lo wer de nt ure) 6 -9 = de nt ures wit h fair rete nti o n a n d sta bilit y.
S u m  sc ore ( u p per + lo wer de nt ure) 1 0 -1 4 = de nt ures wit h g o o d rete nti o n a n d sta bilit y.
S u m sc ore ( u p per + l o wer de nt ure) > 1 4 = de nt ures wit h ver y g o o d rete ntio n a n d sta bili t y.
S u bject recr ui t me nt will be c o ntr olle d t o e ns ure 5 0 ± 1 0 % of t he s u bjects will be i n e a c h of t he 
l ow a n d hi g h Ka p ur -Ols ha n gr o u ps [t he l ow Ka p ur -Ols ha n gr o u p is defi ne d a s a c o m p osite 
Ka p ur -Ols ha n sc ore of  6- 1 4 (cli nicall y fair a n d g o o d de nt ures) a n d t he hi g h Ka p ur -Ols ha n 
sc ore as 1 5-1 8 (cli nicall y ver y g o o d de nt ures)].
7. 1. 4
W ell M a d e A s s e s s m e nt
Cli nic al Acce pt a bility
Eac h de nt ure ( u p per a n d l ower) will be e xa mi ne d.  O nl y de nt ures ha vi n g a de q uate (as j u d ge d 
b y a n e xa mi ner wi t h e xpert k n o wl e d ge of  pr ost h o d o ntics) verti cal di me nsi o n , free wa y s pace, 
h ori z o nt al occlusal relati ons hi ps a n d b or der e xte nsi o n will 
be c o nsi dere d cli nicall y 
acce pta ble.  For eac h de nt ure ( u p per a n d l ow er), t he e xa mi ner will i n dicate acce pta ble or 
u nacce pta ble o n t he C R F.
De nt ure Fi nis h a n d C o nt o ur
T he c o nt o ur a n d fi nis h of  eac h de nt ure ( ma xillar y a n d ma n di b ular) will be e xa mi ne d.  Onl y 
de nt ures wit h acce pta ble (as j u d ge d b y a n e xa mi ner wi t h e x pert k n o wle d g e of pr ost h o d o ntics) 
p or osi t y, tiss ue s urfaces, p olis he d s urfaces, c olo ur a n d t hic k ness will be acce pte d.  For eac h 
de nt ure ( u p per a n d l o wer), t he e xa mi ner will i n dicate acce pta ble or u nacce pta ble o n t he C R F.
7. 1. 5
F o o d Mi gr ati o n A d e q u a c y D et er mi n ati o n
S u bjects m u st c o mplete t he f oo d mi grati o n a de q uac y assess me nt w hilst usi n g n o de nt ure 
a d hesi ves/fi xat i ves.  De nt ures s h o uld ha ve bee n clea ne d a n d drie d b y t he st u d y st aff an d 
r e place d i n t he s u bject’s m o ut h.  Su bjects will be pr o vi de d wi t h 30 - 3 2 gra ms (accuratel y 
w ei g he d) of  no n -salte d pea n uts, di vi de d i nto s maller p orti o ns of a p pr o xi matel y ei g ht pea n ut 
hal ves b y t he st u d y  staff.  E a c h p ortio n s h o ul d be c he we d b y t he s u bject f or a p pr o xi matel y 2 0 
sec o n ds, after w hic h t he s u bject will be i nstr ucte d t o s wall o w at a n yti me t he y are c o mf orta ble.  
S u bjects will be allo w e d s m all si ps of  water d uri n g t he pea n ut c o ns u mpt i on t o aid c he wi n g as 
a p pr o priate.  After c o mplet i on of  the pea n ut c o ns u m pt i on, t he s u bject will rinse t heir m o ut h 
wi t h water f or fi ve sec o n ds bef ore r e mo vi n g t heir d e nt ur e.  Su bjects will be as ke d t o r e mo ve 
t heir de nt ures (t he e xa mi ner ma y assist i n t his if re q uire d) a n d place t he m int o a l a belle d tra y 
( wit h su bject scree ni n g n u m ber) teet h side d o w n, a n d ma y r e mo ve a n y resi d ual pea n ut 
parti cles fr om t heir m o ut h wi t h water a n d a ga uze pa d ( n ot f or c ollecti o n).  The a mo u nt of 
f oo d parti cles o n eac h de nt ure will be vis uall y assesse d b y t he e xa mi ner acc or di n g t o t he scale 
bel o w a n d rec or de d i n t he C R F t o d eter mi ne if t here is e vi de nce of pea n ut parti cle mi g rati on 
u n der t he de nt ures.  T he f oll owi n g 0 – 3 assess me nt scale will be use d.  S u bjects w h o prese nt 
n o e vi de nce of  pea n ut particles u n der eit her t he u p per or l ower de nt ure (i.e. if eit her de nt ure 
sc ores as 0) will n ot be eli gi ble. 
T he l o c ati o n a n d e xte nt of  pea n ut particle mi grat i on will be rate d as f o ll ows:
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
2 4- O ct- 2 0 1 7 0 8: 4 9: 0 5
 
2 0 8 3 9 7 Cli ni c al Pr ot o c ol 2. d o c x
el d o _ c o ntr oll e d
2. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d b 1 b 9 1
Pa ge 3 2 of 6 2

S o di u m -calci u m mi xe d partial salt of p ol y( met h yl vi n y let her/ maleic aci d) a n d car b o x y met h ylcell ul ose
2 0 8 3 9 7
Fi nal Cli nica l Pr ot oc ol, 2 0 Oct 2 0 1 7
Gla x o S mit h Kli ne C o ns u mer Healt hcare C o nfi de ntial
Te m plate Ver si o n Effecti ve: 2 2-J u n-2 0 1 7
Pa ge 3 3 of  6 2
0 = N o ne – N o  pea n ut mi grati on u n der t he de nt ure.
1 = Mi ni mal – Sl i g ht mi grati o n of pea n uts u n der t he de nt ure.
2 = M o derate – Mi grati o n of  pea n uts o ver t he i nter nal walls of t he de nt ure.
3 = E xte nsi ve – P ea n uts mi grati o n o n t he crest of t he de nt ure.
De nt ures s h o ul d be clea ne d t h or o u g hl y b y t he st u d y staff pri or t o ret ur ni n g t o t he s u bject.
7. 2
Effi c a c y
T he f oll owi n g 
efficac y assess me nts will 
be p erf or m e d at ti mes defi ne d i n t he St u d y 
Pr oce d ures secti o n of t his pr ot oc ol.  
7. 2. 1
F o o d O c cl u si o n T e sti n g I n c or p or ati n g D e nt ur e Di sl o d g e m e nt 
A s s e s s m e nt
F o o d Occl usi o n will be meas ure d b y a trai ne d or e x perie nce d o perat or usi n g t he met h o d 
descri be d bel o w.  6 0 5 mi n utes after t he de nt ures ha ve b ee n i nserte d:
1.
T he s u bject will be i nstr ucte d t o bite d o w n firml y o n t h ei r de nt ures.  T he s u bject will t he n 
br iefl y rinse t heir m o ut h vi g or o usl y wi t h water.  The sit e staff will r e mo v e a n y a d hesi ve 
t hat is o ozi n g fr o m t he de nt ures.  N ote: T he s u bject must n ot eat a n y f o o d d uri n g t he 6 0 5 
mi n utes wai tin g p eri o d.  S u bj e cts ma y n ot dri n k d uri n g t his 6 0 5 m i n utes perio d wi t h t h e 
e xce pti o n of s mall si ps water.
2.
T he s u bject will be gi ve n 3 0 -3 2 g of  no n -salte d, dr y r oaste d pea n uts t o c he w a n d s wallo w.  
T he 3 2 g p orti o n of  pea n uts will be di vi de d b y t he sit e staff i n t o s maller p orti o ns of 
a p pr o xi matel y 8 pea n ut hal ves (a p pr o xi matel y 4g).  The s u bject will be as ke d t o c he w 
eac h pre -meas ure d p orti o n of  pea n uts f or at  least 2 0 sec o n ds, aft er w hic h t he y ma y 
s wall o w at a n y time t he y are c o mf o rta ble.  The s u bject ma y si p water d uri n g pea n ut 
c o ns u m pti o n.
3.
W hilst 
c o ns u mi n g t he pea n uts t he s u bject s h o uld n ote t he n u m ber of  ti mes t he y 
e x perie nce t heir de nt ure di slo d gi n g.  The t otal nu m ber of  de nt ure disl o d ge me nts f or t he 
s u bject sh o ul d be rec or de d b y  t he st u d y site staff i n t he C R F.
4.
After c o ns u mi n g all of  the pea n uts, t he s u bject will rinse t heir m o ut h wi t h water f or 
a p pr o xi matel y 5 sec o n ds (t o re mo ve a n y pea n ut parti cles n ot retai ne d u n der t he de nt ures).
5.
T he e xa mi ner will  caref ully r e mo v e t he s u bject’s l ower de nt ure a n d pl ace it on a s mall 
tr a y, teet h si de d o w n a n d r e mo ve a n y resi d ual a d hesi ve a n d/ or pea n ut parti cles fr om t he 
l ower g u m  with a pi ece of  ga uze t hat will be pl ace d i n a se parate bea ker c o de d wit h t he 
s u bject scree ni n g nu m ber, treat m e nt perio d a n d “ L” f or l o wer de nt ure.
6.
T he e xa mi ner will  caref ull y re mo v e t he s u bject’s u p per de nt ure a n d pl ace it on a s mall 
tr a y, teet h si de d o w n a n d r e mo ve a n y resi d ual a d hesi ve a n d/ or pea n ut parti cles fr om t he 
r o of of t h e mo ut h wi t h a piece of  ga uze t hat will be place d i n a se parate bea ker c o de d wit h 
t he s u bject scree ni n g n u m ber, treat me nt peri o d a n d “ U” f or u p per de nt ure.
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
2 4- O ct- 2 0 1 7 0 8: 4 9: 0 5
 
2 0 8 3 9 7 Cli ni c al Pr ot o c ol 2. d o c x
el d o _ c o ntr oll e d
2. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d b 1 b 9 1
Pa ge 3 3 of 6 2

S o di u m -calci u m mi xe d partial salt of p ol y( met h yl vi n y let her/ maleic aci d) a n d car b o x y met h ylcell ul ose
2 0 8 3 9 7
Fi nal Cli nica l Pr ot oc ol, 2 0 Oct 2 0 1 7
Gla x o S mit h Kli ne C o ns u mer Healt hcare C o nfi de ntial
Te m plate Ver si o n Effecti ve: 2 2-J u n-2 0 1 7
Pa ge 3 4 of  6 2
7.
All t he s urfaces of  the de nt ures will be c hec ke d f or resi d ual pea n uts.  If a n y is f ou n d o n 
a n y s urface ot h er t ha n t hose i n c o ntact wit h oral s oft tiss ue, it will be r e mo ve d wi t h a 
s pat ula a n d discar de d. 
8.
F or a s u bset of  ap pr o xi matel y 5 s u bjects at eac h treat me nt visit, a p h ot o gra p h of  the fit 
s urface of t he de nt ures will be ta ke n as per secti o n 7. 2. 3 .
9.
T he u p per a n d l ower de nt ures of eac h s u bject will be place d i n t he c o de d bea kers wit h t he 
ga uze ( u p per a n d l o wer se paratel y ).
1 0. I mme diatel y f oll o wi n g r e mo v al  of t he pr ost heses t he s u bject will c o m p lete t he st u d y 
q uesti o n naire per sect i on 7. 2. 2 .
1 1. I n t he la b orat or y, a p pr o xi mate l y 1 0 0 ml ( or e n o u g h t o c o ver t he pr ost heses) of  hot de-
i onise d water ( 9 0 ° C, ( 1 9 4 ° F)) will be a d de d t o eac h bea ker.  The bea kers will be 
s o nicate d f or 3 0 mi n utes t o l o ose n a n y a d heri n g pea n ut particles. 
1 2. After s o nicat i on, a n y pea n ut particles st ill re maini n g o n t he pr ost heses or t he ga uze will be 
was he d o ut i nto t he bea ker.  The ga uze pieces will be discar de d a n d t he de nt ures will be 
clea ne d a n d ret ur ne d t o t he s u bject. 
1 3. T he de nt ures s h o ul d be clea ne d t h or o u g hl y bef ore ret ur ni n g t o t he s u bject.
1 4. T he s ol utio ns i n t he bea kers ( mi xt ure of  water, a d hesi ve, sali va a n d pea n ut particles) will 
be heate d t o b oili n g wit h fre q ue nt stirri n g t o diss o l ve a n y u n diss ol ve d a d hesi ve.
1 5. T he h ot s ol ut i on i n eac h bea ker will be strai ne d t hr o u g h a sta n dar d testi n g sie ve, U S A # 6 0 
(c o de d wit h s u bject’s scree ni n g n u m ber, treat me nt c o de a n d U or L f or u p per a n d l ower 
de nt ures).
1 6. T he resid ue r e mai ni n g o n t he scree n will  be was he d re peate dl y wi t h hot water t o re m o ve 
a n y a d hesi ve or sali va.
1 7. T he c ollecte d pea n ut particles will be air -drie d o ver ni g ht o n t he scree n.
1 8. T he dri e d part icles will be tra nsferre d fr o m t he scree n t o pre -wei g he d c o de d (s u bject 
scree ni n g n u m ber, U p per/ L o wer a n d date) alu mi ni u m wei g hi n g pa ns usi n g a s pat ula a n d 
t he n will be drie d i n a n o ve n at 4 0° C ( 1 0 5° F) f or 5 h o urs.
1 9. T he pa ns will be r e mo ve d fr om t he o ve n, c o ole d t o r o o m te mperat ure a n d t he n wei g he d 
(in gra ms, t o 4 deci mal places) t o d eter mi ne t he mass of  t he part icles c o llecte d fr om eac h 
de nt ure.
Pri or t o c o m m e n ci n g t his testi n g t he su bjects will ha ve t he e ntir e f oo d occl usi o n a n d de nt ure 
di slo d ge me nt assess me nt pr oce d ure e x plai ne d t o t he m at eac h visit b y t he e xa mi ner or a 
desi g nee .  A sta n dar d scri pt will be use d t o e ns ure c o nsiste nc y i n pr oce d ures.
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
2 4- O ct- 2 0 1 7 0 8: 4 9: 0 5
 
2 0 8 3 9 7 Cli ni c al Pr ot o c ol 2. d o c x
el d o _ c o ntr oll e d
2. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d b 1 b 9 1
Pa ge 3 4 of 6 2

S o di u m -calci u m mi xe d partial salt of p ol y( met h yl vi n y let her/ maleic aci d) a n d car b o x y met h ylcell ul ose
2 0 8 3 9 7
Fi nal Cli nica l Pr ot oc ol, 2 0 Oct 2 0 1 7
Gla x o S mit h Kli ne C o ns u mer Healt hcare C o nfi de ntial
Te m plate Ver si o n Effecti ve: 2 2-J u n-2 0 1 7
Pa ge 3 5 of  6 2
7. 2. 2
S u bj e ct Q u e sti o n n air e
After t he f oo d occl usi o n  testi n g a n d f oll o wi n g r e mo val of  the de nt ures o n Test Da y s, t he 
s u bject will c o m p lete a q uest i on naire (Secti o n 1 3. 2 ) o n t heir e x perie nce d uri n g t he c he wi n g 
pr oce d ure.  The s u bject res p o nses s h o uld be tra nscri be d b y t he st u d y staff t o t he C R F.  T he 
st u d y st aff s ho ul d be mi n df ul t hat w hilst t he q uesti o n naire d oes n ot s olici t s af et y inf or m at i on,  
a n y i nf or mat i on o n safety o ut c o m es rec or de d b y s u bjects o n t he q uest i on naire s h o uld be 
e val uate d b y t he i n vesti gat or t o e ns ure all A Es are rec or de d.
7. 2. 3
D e nt ur e P h ot o gr a p h s at Tr e at m e nt Vi sit s
F or a s u bset of  su bjects, e xtra or al  di gital ph ot o gra p hs will be ta ke n of  the u n dersi de of  eac h 
de nt ure i m me diatel y aft er t heir r e mo v al  t o doc u me nt t he a p peara nce of  mi grate d particles f or 
s p o ns or re vie w.  S u bjects will be selecte d at t he discreti o n of  t he I n vesti gat or, b ut all o w f or a 
variet y of  de nt ure sizes a n d fit to be re prese nte d.  It is e x pecte d t hat a p pr o xi matel y 5 sets of 
de nt ures be p h ot o gra p he d per treat me nt gr o u p, a n d w here p ossi ble t hat c o nsiste nc y of  
s u bjects bet wee n tr e at me nts is mai ntai ne d (i.e. a s u bject will be i de ntifie d at visit 2 as bei n g 
s uita ble f or de nt ure i ma gi n g a n d will ha ve t heir de nt ures p h ot o gra p he d at visit 2, 3 a n d 4).  
S h o ul d s u bject dr o p o uts or ot her reas o ns necessitate, s u bjects ca n be s u bstit ut e d.  Di gital 
p h ot o gra p hs a n d t heir file na mes s h o uld n ot c o nt ai n a n y pers o nall y i de ntifia ble i nf or mati o n.  
T he di gi t al file s h o uld be a p pr o priatel y na me d t o i de ntif y t he s u bject scree ni n g n u m ber a n d 
t he treat me nt peri o d.  T his pr oce d ure s h o ul d be u n der ta ke n b y t he e xa mi ner or desig nee.
7. 3
S af et y
T he f oll owi n g safety assess me nts will be p erf or m e d at ti mes defi ne d i n t he St u d y  Pr oce d ures
secti on of t his pr ot oc ol.  
7. 3. 1
Or al S oft Ti s s u e ( O S T) E x a mi n ati o n - E d e nt ul o u s
T he O S T e xa mi nat i on s h o uld be p erf or m e d b y a q ualifie d de nt ist an d i deall y t he sa me 
e xa mi ner s h o uld be use d T he O S T 
E xa m -E de nt ul o us will 
i ncl u de t he la bial m uc osa 
(incl u di n g li ps), b uccal m uc osa, t o n g ue, gi n gi val m uc osa, s u bli n g ual area, har d a n d s oft 
p al ates, m uc o gi n gi val f ol ds, s u b ma n di b ular area, sali var y gla n ds, t o nsilar a n d p har y n geal 
areas.  Obser vat i ons will be ma de of  an y er yt he ma, des q ua mat i on a n d ulcerat i ons, a n d ot h er 
r ele va nt cli nical o bser vati o ns.  The res ults of  t he e xa mi nat i on will be rec or de d i n t he C R F as 
eit her n or m al or a b n or mal.  The l ocat i on a n d br ief descri pt i on of  an y a b n or malities will als o 
be rec or de d.
7. 3. 2
Pr e g n a n c y T e sti n g
F or female s u bjects of  chil d beari n g p ote nti al, a uri ne pre g na nc y t est, will be p erf or m e d at 
Vi sit 2 a n d t he n a gai n at Visits 3 a n d 4 i n t he e ve nt t hat more t ha n 3 0 da ys ha ve ela pse d si nce 
t heir pre vi o us Pre g na nc y test. Res ults will be o btai ne d pri or t o d osi n g d uri n g eac h peri o d.  
A ne gat i ve pre g na nc y  res ult is re q uire d bef ore t he s u bject ma y recei ve t he i n vesti gati onal 
pr o d uc t.  Pre g na nc y tests will als o be d o ne w he ne ver o ne me nstr ual c ycle is misse d d uri n g t he 
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
2 4- O ct- 2 0 1 7 0 8: 4 9: 0 5
 
2 0 8 3 9 7 Cli ni c al Pr ot o c ol 2. d o c x
el d o _ c o ntr oll e d
2. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d b 1 b 9 1
Pa ge 3 5 of 6 2

S o di u m -calci u m mi xe d partial salt of p ol y( met h yl vi n y let her/ maleic aci d) a n d car b o x y met h ylcell ul ose
2 0 8 3 9 7
Fi nal Cli nica l Pr ot oc ol, 2 0 Oct 2 0 1 7
Gla x o S mit h Kli ne C o ns u mer Healt hcare C o nfi de ntial
Te m plate Ver si o n Effecti ve: 2 2-J u n-2 0 1 7
Pa ge 3 6 of  6 2
acti ve st u d y p eri o d ( or w he n p ot e nti al pre g na nc y is ot h er wise s us pecte d). Pre g na nc y tests 
ma y als o be re peate d as per re q uest of I R Bs/ E Cs or if re q uire d b y l ocal re g ula tio ns.
I n t he case of a p osi tive c o nfir me d pre g na nc y , t he s u bject will 
be wi t hdra w n fr o m 
a d mi nistrati o n of i n vest i gati onal pr o d uct a n d fr o m t he st u d y .
If a uri ne sa m ple is c ollecte d as part of t he pre g na nc y testi n g it will be dis p ose d of 
i m me diatel y aft er t he c o nclusi o n  of t he test
8
A D V E R S E E V E N T A N D O T H E R E V E N T S O F S P E CI A L 
I N T E R E S T R E P O R TI N G
8. 1
D efi niti o n s of A d v er s e E v e nt s a n d S eri o u s A d v er s e E v e nt s
8. 1. 1
A d v er s e E v e nt
A n A E is a n y unt o war d me d ical occ urre nce i n a cli nical st u d y partici pa nt, t e mp orall y 
ass ociate d w ith t he use of a n i n vesti g ati o n al  or was h o ut pr o d uct or me dical de vice, w het her or 
n ot c o nsi dere d rel ate d t o t he i n vest i gati onal or was h o ut pr o d uct or me dical de vice.
N O T E: A n A E ca n t heref ore be a n y u nfa v o ura 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 ( ne w or e xacer bate d) te m p orall y ass ociate d wi t h t he 
use of a st u d y  tr e at me nt.
E ve nts Meeti n g
t he A E Defi niti o n:  

A n y a b n or mal safet y assess me nts (e. g., O S T fi n di n gs, i ncl u di n g t hose t hat w o rse n 
fr om baseli ne, c o nsi dere d cli nicall y si g nifica nt i n t he me d ical a n d scie ntific j u d g me nt 
of  t he i n vesti gat or (ie, n ot relate d t o pr o gressi o n of u n derl yi n g disease)).

E xacer bat i on of  a chr o nic or i nter mitte nt pre -e xisti n g c o n ditio n  incl u di n g eit her a n 
i ncrease i n fre q ue nc y a n d/ or i nte nsit y of  t he c o n ditio n .

Ne w c o n ditio ns detecte d or dia g n ose d aft er st u d y treat me nt a d mi nistrati o n e ve n 
t ho u g h it m a y ha ve bee n prese nt bef ore t he start of t he st u d y.

Si g ns, s y m pt o ms, or t he cli nical se q uelae of a s us pecte d dr u g -dr u g i nteracti o n .

Si g ns, s y m pt o ms, or t he cli nical se q uelae of  a sus pecte d o ver d ose of  either st u d y 
treat me nt or a c o nc o mita nt me d icati on. O ver d ose per se will n ot be re p orte d as a n 
A E/ S A E u nless it is a n i nte ntio nal o ver d ose ta ke n wi t h p ossi ble s uici dal/self-har mi n g 
i nte nt . S uc h o ver d oses s h o ul d be re p orte d re gar dless of se q uelae.

" Lac k of efficac y" or "f ail ure of  ex pecte d p har m a c olo gi cal act i on" per se will n ot be 
re p orte d as a n A E 
or S A E. S uc h i nsta nces will 
be ca pt ure d i n t he efficac y 
assess me nts. H o we ver, t he si g ns, sy m pt o m s, a n d/ or cli nical se q uelae res ultin g fr om 
lac k of efficac y will be re p orte d as A E or S A E if t he y f ulfil t he defi nitio n of  a n AE or 
S A E. 
E ve nts N O T meeti n g t he A E defi niti o n: 
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
2 4- O ct- 2 0 1 7 0 8: 4 9: 0 5
 
2 0 8 3 9 7 Cli ni c al Pr ot o c ol 2. d o c x
el d o _ c o ntr oll e d
2. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d b 1 b 9 1
Pa ge 3 6 of 6 2

S o di u m -calci u m mi xe d partial salt of p ol y( met h yl vi n y let her/ maleic aci d) a n d car b o x y met h ylcell ul ose
2 0 8 3 9 7
Fi nal Cli nica l Pr ot oc ol, 2 0 Oct 2 0 1 7
Gla x o S mit h Kli ne C o ns u mer Healt hcare C o nfi de ntial
Te m plate Ver si o n Effecti ve: 2 2-J u n-2 0 1 7
Pa ge 3 7 of  6 2

A n y 
cli nicall y si g nifica nt a b n or mal la b orat or y fi n di n gs (if a p plica ble) o r ot her 
a b n or mal safet y assess me nts w hic h are ass ociate d wi t h the u n derl yi n g disease, u nless 
j u d ge d b y t he i n vesti gat or t o be m ore se vere t ha n e x pecte d f or t he s u bject’s c o n diti on. 

T he disease/ dis or der bei n g st u di e d or e x pecte d pr o gressio n, si g ns, or s y m p t o ms of t he 
di sease/ dis or der bei n g st u die d, u nless m o re se vere t ha n e x pecte d f or t he s u bject’s 
c o n ditio n. 

Me dical or s ur gical pr oce d ure (e. g., e n d osc o p y, a p pe n dect o m y) is n ot t he A E. T he 
c o n ditio n t hat l ea ds t o t he pr oce d ure is a n A E (e. g., a p pe n dicit is).

Si t u atio ns w here a n u nt o war d me d ical occ urre nce di d n ot occ ur (s ocial a n d/ or 
c o n ve nie nce a d missi o n t o a h os pital).

A nt ici pate d d a y -t o-d a y  fl uct uatio ns of  pre-e xist i n g di sease(s) or c o n dit i on(s) prese nt 
or detecte d at t he start of t he st u d y  t hat d o n ot w orse n. 
8. 1. 2
S eri o u s A d v er s e E v e nt
If a n e ve nt is n ot a n A E per defi ni tio n  ab o ve, t he n it ca n n ot be a n S A E e ve n if serio us 
c o n ditio ns are met (e. g., h os pitalisat i on f or si g ns/s y m pt o ms of  t he disease u n der st u d y, d e at h 
d ue t o pr o gressi o n of disease).
A seri o us a d v erse e ve nt is a n y u nt o war d me dical occ urre nce at a n y d ose t hat:

Res ults i n de at h

Is life-t hre ate ni n g

T he t er m 'life-t hreate ni n g' i n t he defi ni tio n of  'seri o us' r efers t o a n eve nt i n w hic h 
t he partici pa nt was at ris k of  deat h at t h e ti me of  t he e ve nt. It d oes n ot refer t o a n 
e ve nt, w hic h h y p ot heticall y mi g ht ha ve ca use d deat h, if it were m ore se vere;

Re q uires i n p atie nt h os pit alis ati o n or pr ol o n g ati o n of e xisti n g h os pit alis ati o n

I n ge neral , h os pi talisati on si g nifies t hat t h e parti ci pa nt has bee n detai ne d ( us uall y 
i n v ol vi n g at least a n o ver ni g ht st a y) at t he h os pi t al or e mer ge nc y war d f or 
o bser vat i on a n d/ or treat me nt t hat w o ul d n ot ha ve bee n a p pr o priate i n t he 
p h ysicia n’s of fice or o ut pati e nt setti n g. C o m plicat i ons t hat occ ur d uri n g 
h os pi talisati on are A E. If a c o mplicati o n pr o l on gs h os pi talisati on or f ulfils a n y 
ot her serio us crit eria, t he e ve nt is serio us. W he n 
i n d o u bt as t o w het her 
“ h os pitalisat i on” occ urre d or was necessar y , t he A E s h o uld be c o nsi dere d seri o us.

H os pitalisat i on f or elect i ve treat me nt of a pre -e xisti n g c o n dit i on t hat di d n ot 
w orse n fr o m baseli ne is n ot c o nsi dere d a n A E.

Res ults i n persiste nt or si g nific a nt dis a bilit y/i nc a p acit y

T he t er m disa bilit y mea ns a s u bsta ntial disr u pt i on of  a pers o n’s a bilit y t o c o nd uct 
n or m al lif e fu nct i ons.

T his d ef i niti on is n ot i nte n de d t o i ncl u de e x perie nces of  relati vel y mi n or me d ical 
sig nifica nce s uc h as u nc o m p licate d hea dac he, na usea, v o mit i n g, di arr h oea, 
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
2 4- O ct- 2 0 1 7 0 8: 4 9: 0 5
 
2 0 8 3 9 7 Cli ni c al Pr ot o c ol 2. d o c x
el d o _ c o ntr oll e d
2. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d b 1 b 9 1
Pa ge 3 7 of 6 2

S o di u m -calci u m mi xe d partial salt of p ol y( met h yl vi n y let her/ maleic aci d) a n d car b o x y met h ylcell ul ose
2 0 8 3 9 7
Fi nal Cli nica l Pr ot oc ol, 2 0 Oct 2 0 1 7
Gla x o S mit h Kli ne C o ns u mer Healt hcare C o nfi de ntial
Te m plate Ver si o n Effecti ve: 2 2-J u n-2 0 1 7
Pa ge 3 8 of  6 2
i nfl ue nza, a n d acci de ntal tra u ma (e. g., s prai ne d a n kle) w hic h ma y i nterfere wit h or 
pre ve nt e ver y d a y  lif e fu nct i ons b ut d o n ot c o nstit ute a s u bsta nt ial disr u pti o n

Res ults i n c o n ge nit al a n o m al y/ birt h defect

Ot her sit u ati o ns

Me dical 
or scie nt ific j u d g me nt s h o uld be e xercise d i n deci di n g w het her S A E 
re p orti n g is a p pr o priate i n ot h er sit u atio ns s uc h as i m p orta nt me dical e ve nts t hat 
ma y n ot be i m me diatel y life-t hreate ni n g or res ult i n deat h or h os pi talisati on b ut 
ma y je o par dize t he parti ci pa nt or ma y re q uire me di cal or s ur gical i nter ve nt i on t o 
pre ve nt o ne of  the ot h er o utc o m es liste d i n t he a b o ve defi ni tio n . T hese e ve nts 
s h o uld us uall y be c o nsi dere d seri o us.

E xa m ples of  suc h e ve nts i ncl u de i n vasi ve or ma li g na nt ca ncers, i nte nsi ve 
treat me nt i n a n e mer ge nc y r o o m or at h o me f or aller gic br o nc h os pas m, bl o o d 
d y scrasias or c o n v ulsi o ns t hat d o n ot res ult i n h os pi talisati on, or de vel o p me nt of 
dr u g de pe n de nc y  or dr u g a b use.
8. 2
R e p orti n g P eri o d
8. 2. 1
A d v er s e E v e nt
A Es will be c o llecte d fr o m t he first use of i n vesti gati o nal treat me nt at  Visit 2 a n d u nt il 5 d a ys 
f oll owi n g last a d mi nistrati o n of treat me nt . 
Me dical 
occ urre nces t hat be gi n bef ore t he start of  st u d y treat me nt b ut aft er o btai ni n g 
i nf or me d c o nse nt will be rec or de d o n t he Me dical Hist or y / C urre nt Me dical C o n dit i ons sect i on 
of  t he case re p ort f or m ( C R F) n ot t he A E secti on.
8. 2. 2
S eri o u s A d v er s e E v e nt
S A Es assesse d as rel ate d t o stu d y pa rtici pat i o n (e. g., i n vesti gati onal pr o d uct, pr ot oc ol 
ma n date d pr oce d ures, i n vasi ve tests, or c ha n ge i n e xist i n g t hera p y) or relate d t o a G S K 
c o nc o mita nt me d icati on will be rec or de d fr om t he ti me a s u bject pr o vi des i nf or me d c o nse nt, 
w hic h is o btai ne d pri or t o t he s u bject’s partici pat i o n i n t he st u d y, i. e., prior t o u n der g oi n g a n y 
st u d y-relate d pr oce d ure a n d/ or recei vi n g i n vesti gatio nal pr o d uct a n d u ntil 5 da ys f oll owi n g 
last a d mi nistrati o n of t he i n vesti gati onal pr o d uct.
S A Es assesse d as n ot rel ate d t o st u d y partici p ati o n  (e. g., i n vesti gati onal pr o d uct, pr ot oc ol 
ma n date d pr oce d ures, i n vasi ve tests, or c ha n ge i n e xist i n g t hera p y) or n ot relate d t o a G S K 
c o nc o mita nt me d icatio n will be rec or de d fr om t he ti me t he s u bjects pr o vi des i nf or me d 
c o nse nt a n d u nt il 5 da ys fol l owi n g last a d mi nistrati o n of t he i n vest i gati o nal pr o d uct. 
8. 3
R e p orti n g Pr o c e d ur e s
T he i n vesti gat or a n d a n y desi g nees are res p o nsi ble f or detecti n g, d oc u me nti n g a n d re p orti n g 
e ve nts t hat me et t he defi nit i on of  an A E or S A E a n d re mai n res p o nsi ble f or f oll owi n g u p o n 
A Es t h at ar e s eri o us, c o nsi d er e d r elate d t o t he st u d y  tr e at me nt or t h e st u d y, or t h at c a us e d t h e 
parti ci pa nt t o disc o nti n ue t he st u d y treat me nt. 
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
2 4- O ct- 2 0 1 7 0 8: 4 9: 0 5
 
2 0 8 3 9 7 Cli ni c al Pr ot o c ol 2. d o c x
el d o _ c o ntr oll e d
2. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d b 1 b 9 1
Pa ge 3 8 of 6 2

S o di u m -calci u m mi xe d partial salt of p ol y( met h yl vi n y let her/ maleic aci d) a n d car b o x y met h ylcell ul ose
2 0 8 3 9 7
Fi nal Cli nica l Pr ot oc ol, 2 0 Oct 2 0 1 7
Gla x o S mit h Kli ne C o ns u mer Healt hcare C o nfi de ntial
Te m plate Ver si o n Effecti ve: 2 2-J u n-2 0 1 7
Pa ge 3 9 of  6 2
T he i n vesti gat or is t o r e p ort all di r e ctl y o bser ve d A Es a n d all A Es s p o nta ne o usl y re p orte d b y 
t he st u d y s u bject. I n a d diti on, eac h st u d y  s u bject will be q uest i one d a b o ut A Es. 
Eac h A E is t o be assesse d t o deter mi ne if it meets t he criteria f or S A Es.  If a n S A E occ urs, 
e x pe dite d re p orti n g will f o ll ow l ocal a n d i nter nat i onal re g ulat i ons, as a p pr o priate.
W he n 
a n A E/ S A E 
occ urs, it is t he res p o nsi bility of  the i n vesti gat or t o re vie w all 
d oc u m e nt atio n (e. g., h os pi t al pr o gress n otes, la b orat or y, a n d dia g n ostics re p orts) relate d t o t he 
e ve nt.
T he i n vesti g at or or si te staff will t he n rec or d all rele va nt i nf or matio n re gar di n g a n A E/ S A E i n 
t he C R F.
It is n ot acce pta ble f or t he i n vesti gat or t o se n d p h ot oc o pi es of  the parti ci pa nt’s me dical 
rec or ds t o G S K i n lie u of c om p leti o n of t he G S K / A E/ S A E C R F pa ge.
T here ma y be i nsta nces w he n c o pies of  me dical rec or ds f or cert ai n cases are re q ueste d b y 
G S K.  I n t his i nsta nce, all s u bject i de nt ifiers, wit h t he e xce pti on o f t he s u bject n u m ber, will be 
bli n de d o n t he c o pies of t he me dical rec or ds pri or t o s u b missi o n t o G S K.
T he i n vesti gat or will att e mpt t o esta blis h a di a g n osis of t he e ve nt base d o n sig ns, s y m pt o ms, 
a n d/ or ot her cli nical i nf or mati o n.  In s uc h cases, t he di a g n osis will be d o c u m e nte d as t he 
A E/ S A E a n d n ot t he i n di vi d ual si g ns/s y m pt o ms. Cli nical A E s will be descri be d b y dia g n osis 
a n d n ot b y s y m pt o ms w he n p ossi ble (e. g., u p per res pir at or y tract i nfecti on, seas o nal aller g y, 
etc. i nstea d of r u n n y n ose).
Me dical 
c o n ditio n s re p orte d pri or t o t he ti me p eri o d f or re p orti n g A Es/ S A Es s h o uld be 
rec or de d as part of t he s u bject’s me dical hist or y.
A Es elicite d b y t he i n vesti gat or in a sta n dar d ma n ner at t he st u d y visits s h o uld als o b e 
rec or de d i n t he A E secti on of  the C R F. Care will be ta ke n n ot t o i ntr o d uce bias w he n 
detecti n g A E a n d/ or S A E. O pe n -e n de d a n d n o n- lea di n g ver bal q uest i oni n g of  the partici pa nt 
is t he preferre d met h o d t o i n q uire a b o ut A E occ urre nce.
8. 3. 1
A d v er s e E v e nt
All A Es will be re p orte d o n t he A E pa ge(s) of  the C R F b y t he i n vesti gat or or sit e staff.  It 
s h o uld be n ote d t hat t he f or m for c o llecti on of S A E i nf or mati on is n ot t he sa me as t he A E  
C R F.  
Where t he sa me data are c ollecte d, t he f or ms m u st be c o m p lete d i n a c o nsiste nt 
ma n ner.  For e xa m ple, t he sa me A E t er m sh o ul d be use d o n b ot h f or ms.  AE s h o uld be 
re p orte d usi n g c o ncise me dical ter mi n ol og y o n t he C R F as well as o n t he f or m for c oll e cti o n 
of  S A E i nf or mat i on.
8. 3. 2
S eri o u s A d v er s e E v e nt
A pa per c o p y of t he S A E f or m pr o vi de d i n t he i n vesti gat or stu d y master file s h o uld be 
c o mplete d as f ull y as p ossi ble. 
It is esse ntial t o e nter t he f oll o wi n g i nf or mati on: 
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
2 4- O ct- 2 0 1 7 0 8: 4 9: 0 5
 
2 0 8 3 9 7 Cli ni c al Pr ot o c ol 2. d o c x
el d o _ c o ntr oll e d
2. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d b 1 b 9 1
Pa ge 3 9 of 6 2

S o di u m -calci u m mi xe d partial salt of p ol y( met h yl vi n y let her/ maleic aci d) a n d car b o x y met h ylcell ul ose
2 0 8 3 9 7
Fi nal Cli nica l Pr ot oc ol, 2 0 Oct 2 0 1 7
Gla x o S mit h Kli ne C o ns u mer Healt hcare C o nfi de ntial
Te m plate Ver si o n Effecti ve: 2 2-J u n-2 0 1 7
Pa ge 4 0 of  6 2

Pr ot oc ol  a n d s u bject ide nt ifiers

S u bject’s de m o gra p h y

Descri pt i on o f e ve nts, wit h dia g n osis if a vaila ble

I n vesti gat or o pi ni on of relati o ns hi p t o st u d y  pr o d uct 

Cri t erio n f or s eri o us ness.
T he f oll owi n g are desira ble a n d are of  partic ul ar rele va nce f or i n vesti gat or a n d G S K C H 
assess me nt of t he S A E re p ort:

Date of o nset of A E 

Date A E st o p pe d, if rele va nt

St u d y  pr o d uct start date

St u d y  pr o d uct e n d date if rele va nt

Act i on ta ke n o n st u d y  pr o d uct

O utc o m e if k n o w n
T he S A E f or m, c o m p lete d as f ull y as p ossi ble, m ust be e- ma ile d t o t he G S K C H Cli nical 
O perati o ns Sa fety Re p orti n g e mail b o x wi t h the st u d y nu m ber a n d s u bject n u m ber i n t he 
s u bject li ne of  the e mail i m me di atel y a n d u n der n o circ u mst a nce s h o ul d t his e xcee d 2 4 
h o urs aft er st u d y site pers o n nel lear n of  the e ve nt. T he i n vesti gat or will s u b mit a n y u p date d 
S A E data t o t he s p o ns or, i m me di atel y a n d u n der n o circ u mst a nce s h o ul d t his e xcee d 2 4 
h o urs of  it bei n g a vaila ble. T h e G S K C H St u d y Ma na ger 
s h o uld als o be n otifie d of  the 
sit u atio n b y  t ele p h o ne or e mail.
E m ail Seri o us A d verse E ve nts t o:
T h e G S K C H St u d y  M a n a g er or d esig n e e will  be res p o nsi ble f or f or war di n g t he S A E f or m t o 
t he Case Ma na ge me nt 
Gr o u p, 
Gl o bal 
Cli nical S af et y a n d P h ar mac o vi gila nce mail b o x 
T he i nitial re p ort will be f oll owe d u p wi t h mor e i nf or mat i on as rele va nt, or as re q ueste d b y 
t he G S K C H st u d y ma na ger.
8. 3. 3
S p o n s or’ s R e p orti n g R e q uir e m e nt s t o R e g ul at or y A ut h oriti e s a n d 
Et hi c s C o m mitt e e s
G S K has a le gal res p o nsi bility t o n otif y, as a p pr o priate, t he l ocal re g ulat or y aut h ori t y an d 
ot her re g ul at or y a ut h orities a b o ut t h e s af et y of a pr o d uct u n der cli nical i n vesti gati on.  Pr o m pt 
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
2 4- O ct- 2 0 1 7 0 8: 4 9: 0 5
 
2 0 8 3 9 7 Cli ni c al Pr ot o c ol 2. d o c x
el d o _ c o ntr oll e d
2. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d b 1 b 9 1
Pa ge 4 0 of 6 2
P P D
P P D

S o di u m -calci u m mi xe d partial salt of p ol y( met h yl vi n y let her/ maleic aci d) a n d car b o x y met h ylcell ul ose
2 0 8 3 9 7
Fi nal Cli nica l Pr ot oc ol, 2 0 Oct 2 0 1 7
Gla x o S mit h Kli ne C o ns u mer Healt hcare C o nfi de ntial
Te m plate Ver si o n Effecti ve: 2 2-J u n-2 0 1 7
Pa ge 4 1 of  6 2
n otificati o n of  SA Es b y t he i n vesti gat or t o G S K is esse nt ial s o t hat le gal o bli gat i ons a n d 
et hical res p o nsi bilit ies t o war ds t he safety of  s u bjects are met.
G S K will c o m pl y wi t h c o u ntr y specific re g ulat or y re q ui re me nts relat i n g t o s afet y re p orti n g t o 
t he re g ulat or y a ut h orit y, I R B/ E C a n d i n vesti gat ors.
I n vesti gat or safety re p orts m u st be pre pare d f or s us pecte d u ne x pecte d serio us a d verse 
reactio ns ( S U S A R) acc or di n g t o l ocal re g ulat or y re q uire me nts a n d s p o ns or p olic y a n d 
f or war de d t o i n vesti gat ors as necessar y.
A n i n vesti gat or w h o recei ves a n i n vesti gat or safet y r e p ort descri bi n g a S A E or ot h er s pecific 
safety i nf or mati o n e. g., s u m mar y or listi n g of S A E) f r o m t he s p o ns or will re vie w a n d t he n file 
it alo n g wi t h t he I n vesti gat or’s Br oc h ure a n d will n otif y t he I R B/I E C, if a p pr o priate acc or di n g 
t o lo c al  r e q uire me nts.
8. 4
E v al u ati n g A d v er s e E v e nt s a n d S eri o u s A d v e r s e E v e nt s
8. 4. 1
S e v erit y A s s e s s m e nt
T he i n vesti gat or or desi g nee will ma ke a n assess me nt of  se v erit y for eac h A E a n d S A E 
re p orte d d uri n g t he st u d y a n d will assig n i t t o o ne of t he f oll o wi n g cate g ories:

Mil d:  A n e ve nt t hat i s easil y t olerate d b y t he s u bject, ca usi n g mi ni mal disc o mf ort a n d 
n ot i nterferi n g wit h e ver y da y act i vities.

M o derate: 
 An e ve nt t hat is s ufficie ntl y disc o mf orti n g t o i nterfere wi t h nor m al 
e ver y da y act i vities

Se vere:  A n e ve nt t hat pre ve nts n or mal e ver y da y acti vit ies. 
N ote: A n A E t hat is as sesse d as se vere will  not be c o nf use d wi t h an S A E. Se verit y is a 
cate g or y utilise d f or rati n g t he i nte nsit y of a n e ve nt; a n d b ot h A Es a n d S A Es ca n be assesse d 
as se vere. F or e xa m ple, a hea dac he ma y be se vere (i nterferes si g nifica ntl y wi t h the s u bject's 
us u al fu nct i on) b ut w o ul d n ot be classifie d as s erio us u nless it met o ne of  the criteria f or 
S A Es, liste d a b o ve. 
8. 4. 2
C a u s alit y A s s e s s m e nt
T he ca usalit y assess me nt is o ne of  the criteria use d w he n deter mi ni n g re g ulat or y re p ortin g 
re q uire me nts. F or eac h A E/ S A E, t he i n vesti gat or m ust
d o c u m e nt i n t he me dical n otes t hat 
he/s he has re vie we d t he A E/ S A E 
a n d has pr o vi de d a n assess me nt of  ca usalit y. T h e 
i n vesti gat or’s assess me nt of ca usalit y must be pr o vi de d f or all A Es (seri o us a n d n o n- serio us); 
t he i n vest i gat or m ust rec or d t he ca usal relati ons hi p i n t he C R F, as a p pr o priate, a n d re p ort s uc h 
a n assess me nt i n acc or da nce wit h t he S A E re p orti n g re q uire me nts if a p plica ble.
A "reas o na ble p ossi bilit y" of  a relatio ns hi p c o n ve ys t hat t here are facts, e vide nce, a n d/ or 
ar g u me nts t o s u g gest a ca usal r elat i ons hi p, rat her t ha n a relati ons hi p ca n n ot be r ule d o ut. 
Ge nerall y, t he facts (e vi de nce) or ar g u me nts t o s u g gest a ca usal relatio ns hi p s h o uld be 
pr o vi de d.
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
2 4- O ct- 2 0 1 7 0 8: 4 9: 0 5
 
2 0 8 3 9 7 Cli ni c al Pr ot o c ol 2. d o c x
el d o _ c o ntr oll e d
2. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d b 1 b 9 1
Pa ge 4 1 of 6 2

S o di u m -calci u m mi xe d partial salt of p ol y( met h yl vi n y let her/ maleic aci d) a n d car b o x y met h ylcell ul ose
2 0 8 3 9 7
Fi nal Cli nica l Pr ot oc ol, 2 0 Oct 2 0 1 7
Gla x o S mit h Kli ne C o ns u mer Healt hcare C o nfi de ntial
Te m plate Ver si o n Effecti ve: 2 2-J u n-2 0 1 7
Pa ge 4 2 of  6 2
T he i n vesti gat or will use cli nical j u d g me nt t o deter mi ne t he relatio ns hi p a n d will als o c o ns ult 
t he I n vesti gat or Br oc h ure (I B), Safet y St at e m e nt a n d/ or Pr o d uct I nf or mati on, f or mar kete d 
pr o d ucts, i n t he deter mi nat i on of  his/ her assess me nt.  Alter nati ve ca uses, s uc h as u n derl yi n g 
di sease(s), c o nc o mit a nt t hera p y, ot her ris k fact ors, a n d t he t e mp or al  relat i ons hi p of  the e ve nt 
t o t he st u d y pr o d uct will be c o nsidere d a n d i n vest i gate d.
T here ma y be sit u atio ns w he n a n S A E has occ urre d a n d t he i n vesti gat or has mi ni ma l 
i nf or mat i on t o i ncl u de i n t he i nitial re p ort t o G S K.  H o we ver, it is ver y i m p ort a nt t h at t he 
i nvesti g at or al w a ys m a ke a n assess me nt of c a us alit y f or e ver y e ve nt p r i or t o t he i niti al 
tr a ns missi o n of t he S A E d at a t o G S K. T he i n vesti gat or ma y c ha n ge his/ her o pi ni o n of  
ca usalit y i n li g ht of f oll o w-u p i nf or mat i on a n d se n d a n S A E f oll o w -u p re p ort wi t h t he u p date d 
ca usalit y assess me nt. 
8. 5
Wit h dr a w al D u e t o a n A d v er s e E v e nt a n d S eri o u s A d v er s e 
E v e nt s
Wit h dra wal d ue t o A Es s h o uld be dist i n g uis he d fr om wi t hdra wal  due t o ot her ca uses, 
acc or di n g t o t he defi nit i on of  AE n ote d earlier, a n d rec or de d o n t he a p pr o priat e A E C R F
pa ge. 
W he n a s u bject wi t hdra ws beca use of  a n S AE, t he S A E m ust be re p orte d i n acc or da nce wi t h 
t he re p orti n g re q uire me nts defi ne d bel o w.
8. 6
Pr e g n a n c y
8. 6. 1
Ti m e P eri o d f or C oll e cti n g Pr e g n a n c y I nf or m ati o n
Pre g na nc y i nf or mat i on will be c o llecte d o n all pr e g na ncies re p orte d f oll owi n g a d mi nistratio n 
of  an y i n vesti gati onal pr o d uct or was h o ut 
pr o d uct a n d u nt il 5 da ys f oll owi n g 
last 
a d mi nistrati o n of t he i n vesti gat i onal pr o d uct. 
8. 6. 2
A cti o n t o b e T a k e n if Pr e g n a n c y O c c ur s
T he i n vest i gat or will c ollect pre g na nc y i nf ormati o n o n a n y s u bject w h o bec o mes pre g na nt 
w hile partici pat i n g i n t he st u d y after a d mi nistratio n of  t he i n vesti gati o nal pr o d uct or was h o ut 
pr o d uct. T he i n vest i gat or will rec or d pre g na nc y i nf or mati o n o n t he a p pr o priate f or m a n d e-
mail it t o t he G S K C H Cli ni cal O perat i ons Safet y Re p orti n g e mail b o x 
wi t hi n 2 4 h o urs of lear ni n g of t he s u bject bec o mi n g pre g na nt. T he G S K 
C H St u d y  Ma na ger or desi g nee will be res p o nsi ble f or f or war di n g t he S A E f or m t o t he Case 
Ma na ge me nt Gr o u p, Gl o bal Cli nical Safet y a n d P har mac o vi gila nce mail b o x 
T he s u bject will be f oll owe d t o deter mi ne t he o ut c o m e of  the pre g na nc y. I nfor m at i on o n t he 
stat us of  t he m o t her a n d i nfa nt / ne o nate (incl u di n g c o nc o mit a nt me d icatio ns ta ke n b y t he 
m o t her d uri n g t he pre g na nc y) will be f or war de d b y t he i n vesti gat or t o t he G S K C H Cli nical 
O perati o ns Safet y Re p orti n g e mail bo x a n d t he G S K C H St u d y  Ma na ger or desi g nee will 
f or war d t his i nf or mat i on t o t he Case Ma na ge me nt 
Gr o u p, Gl o bal Cli nical S af et y a n d 
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
2 4- O ct- 2 0 1 7 0 8: 4 9: 0 5
 
2 0 8 3 9 7 Cli ni c al Pr ot o c ol 2. d o c x
el d o _ c o ntr oll e d
2. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d b 1 b 9 1
Pa ge 4 2 of 6 2
P P D
P P D

S o di u m -calci u m mi xe d partial salt of p ol y( met h yl vi n y let her/ maleic aci d) a n d car b o x y met h ylcell ul ose
2 0 8 3 9 7
Fi nal Cli nica l Pr ot oc ol, 2 0 Oct 2 0 1 7
Gla x o S mit h Kli ne C o ns u mer Healt hcare C o nfi de ntial
Te m plate Ver si o n Effecti ve: 2 2-J u n-2 0 1 7
Pa ge 4 3 of  6 2
P har mac o vi gila nce gr o u p ma il b ox at G S K 
. Ge nerall y, foll o w -u p will 
be n o l on ger t ha n 6 t o 8 w e e ks f oll owi n g t he esti mated deli ver y date. A n y ter mi nati on of  t he 
pre g na nc y will be re p orte d.
W hile 
pre g na nc y itself is n ot c o nsi dere d t o be a n A E, a b n or mal pre g na nc y  outc o mes (e g, 
s p o nta ne o us a b ortio n, f oet al deat h, still birt h, c o n ge nital a n o ma lies, ect o pic pre g na nc y) are 
c o nsi der e d t o be a n d s h o ul d be rec or de d as a n S A E.
A n y fe male part ici pa nt w h o bec o mes pre g na nt w hile partici pati n g will be with dra w n fr o m t he 
st u d y.
8. 7
F oll o w -u p of A d v er s e E v e nt s a n d S eri o u s A d v er s e E v e nt s
After t he i nitial re p ort, t he i n vesti gat or is re q uire d t o proacti vel y f oll o w u p wi t h e a c h s u bj e ct 
a n d pr o vi de f urt her i nf or mati o n o n t he s u bject’s c o n dit i on.
All A E s/ S A Es will be f oll owe d u nt il res ol uti on, u ntil t he c o n dit i on sta bilises, u ntil t he e ve nt is 
ot her wi se e x plai ne d, or u ntil t he s u bject is l ost t o f oll o w-u p.  
T he i n vesti gat or is o bli gate d t o perf or m or arra n ge f or t he c o n d uct of  su p ple me ntal 
meas ure me nts a n d/ or e val uati o ns as ma y be i n dicate d or as re q ueste d b y G S K t o eluci date as 
f ull y as p ossi ble t he nat ure a n d/ or ca usalit y of  the A E or S A E. T his ma y incl u de a d ditio n al 
la b orat or y tests or i n vesti gati ons, hist o pat h ol o gical  exa mi nat i ons, or c o ns ultati o n wi t h ot her 
healt h care pr ofessi o nals.
Ne w or u p date d i nf or mat i on will be rec or de d i n t he ori gi nall y c o m p lete d C R F.
T he i n vesti gat or will s u b mit a n y u p date d S A E data t o G S K wi t hi n 2 4 h o urs of  receipt of  the 
i nf or mat i on.
I n vesti gat ors are n ot o bli ge d t o acti vel y see k A Es or S A Es i n f or mer s u bjects.  Ho we ver, if 
t he i n vesti gat or learns of  an y S A E, i ncl u di n g t he deat h, at a n y time aft er a s u bject has bee n
di sc har ge d fr om t he st u d y, a n d c o nsi ders t he e ve nt reas o na bl y relate d t o t he i n vesti gati onal 
pr o d uct or stu d y partici pati o n, t he i n vesti gat or will pr o m pt l y n otif y G S K b y e maili n g t he 
i nf or mat i on t o t he G S K C H Cli nical O perati o ns S af et y Re p orti n g e mail b o x
. T h e G S K C H St u d y Ma na ger 
or desi g nee will be res p o nsi ble f or 
f or war di n g t he i nf or mat i on t o t he Case Ma na ge m e nt Gr o u p, Gl o bal Cli nical S af et y a n d 
P har mac o vi gila nce gr o u p ma il b ox at G S K 
T he i n vesti gat or will s u b mit a n y u p date d S A E data t o G S K wi t hi n t he desi g nate d re p orti n g 
ti me fra mes.
8. 8
D efi niti o n of a n d Pr o c e d ur e f or R e p orti n g M e di c al D e vi c e 
I n ci d e nt s
Me dical de vice s are bei n g pr o vi de d b y G S K C H f or use i n t his st u d y na mel y t he Test De nt ure 
A d hesi ve, t he de nt ure br us hes a n d t he de nt ure clea nsi n g paste.
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
2 4- O ct- 2 0 1 7 0 8: 4 9: 0 5
 
2 0 8 3 9 7 Cli ni c al Pr ot o c ol 2. d o c x
el d o _ c o ntr oll e d
2. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d b 1 b 9 1
Pa ge 4 3 of 6 2
P P D
P P D
P P D

S o di u m -calci u m mi xe d partial salt of p ol y( met h yl vi n y let her/ maleic aci d) a n d car b o x y met h ylcell ul ose
2 0 8 3 9 7
Fi nal Cli nica l Pr ot oc ol, 2 0 Oct 2 0 1 7
Gla x o S mit h Kli ne C o ns u mer Healt hcare C o nfi de ntial
Te m plate Ver si o n Effecti ve: 2 2-J u n-2 0 1 7
Pa ge 4 4 of  6 2
8. 8. 1
D efi niti o n of a n I n ci d e nt
A me dical de vice i nci de nt is a n y malf u nct i on or deteri orati o n i n t he c haracteristics a n d/or 
perf or m a nce of  a d e vi c e as well as a n y i na de q uac y i n t he la belli n g or t h e i nstr uctio ns f or use 
w hic h, 
di rectl y or i n directl y, mi g ht 
lea d t o or mi g ht 
ha ve le d t o t he deat h of  a 
parti ci pa nt/ user/ ot her pers o n or t o a seri o us deteri orati o n i n his/ her state of  healt h.
N ot all i nci de nts lea d t o deat h or seri o us deteri orati o n i n healt h. T he n o n-occ urre nce of s uc h a 
res ult mi g ht ha ve bee n d ue t o ot her f ort u nate cir c u msta nces or t o t he i nter ve nti o n of  healt h 
care pers o n nel.
It is s ufficie nt t h at:

A n i nci de nt associate d wi t h a de vice ha p pe ne d a n d

T he i nci de nt was s uc h t hat, if it occ urre d a gai n, mi g ht lea d t o deat h or a seri o us 
deteri or ati o n i n healt h.
A seri o us deteri orati o n i n state of healt h ca n i ncl u de a n y  of t h e fol l owi n g:

Life -t hreate ni n g ill ness

P er m a ne nt im pair me nt of b o d y  fu ncti o n or per m a ne nt da ma ge t o b o d y str uct ure

C o n di tio n necessitat i n g me d ical or s ur gical i nter ve nt i on t o pre ve nt o ne of t he a b o ve 

F oetal  distress, f oetal deat h, or a n y c o n ge nit al a b n or malit y or bi rt h defects
E x a m ples of i nci de nts:

A p artici pa nt, user, care gi ver, or healt hcare pr ofessi o nal is i nj ure d as a res ult of a 
me dical de vice fail ure or its mis use.

A partici pa nt’s st u d y  tr e at me nt is i nterr u pte d or c o m pr o mise d b y a me dical de vice 
fail ure.

A mis dia g n osis d ue t o me dical de vice fail ur e lea ds t o i na p pr o priate treat me nt.

A partici pa nt’s healt h deteri orates d ue t o me dical de vice fail ure.
8. 8. 2
R e p orti n g of a n I n ci d e nt s a n d M alf u n cti o n s

All i nci de nts m ust be re p orte d t o G S K wit hi n 2 4 h o urs ( or s o o ner if p ossi ble) of 
t he i n vesti g at or or desi g nee bec o mi n g a w are of t he sit u ati o n.

A n y me dical de vice i nci de nt occ urri n g d uri n g t he st u d y will be d oc u me nte d i n t he 
s u bject's me dical 
rec or ds, i n acc or da nce wi t h the i n vesti gat or's n or m al cli nical 
practi ce, a n d o n t he a p pr o priate I nci de nt Re p ort F or m .  In a ddi tio n, f or i nci de nts 
f ulfilli n g t he defi nit i on of a n A E  or a n S A E, t he a p pr o priate A E C R F pa ge or S A E 
f or m will be c o mplete d a n d re p orte d as per t he A E a n d S A E re p orti n g secti o ns.
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
2 4- O ct- 2 0 1 7 0 8: 4 9: 0 5
 
2 0 8 3 9 7 Cli ni c al Pr ot o c ol 2. d o c x
el d o _ c o ntr oll e d
2. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d b 1 b 9 1
Pa ge 4 4 of 6 2

S o di u m -calci u m mi xe d partial salt of p ol y( met h yl vi n y let her/ maleic aci d) a n d car b o x y met h ylcell ul ose
2 0 8 3 9 7
Fi nal Cli nica l Pr ot oc ol, 2 0 Oct 2 0 1 7
Gla x o S mit h Kli ne C o ns u mer Healt hcare C o nfi de ntial
Te m plate Ver si o n Effecti ve: 2 2-J u n-2 0 1 7
Pa ge 4 5 of  6 2

T he I nci de nt Re p ort F o r m will be c o m p lete d as t h or o u g hl y as p ossi ble a n d si g ne d b y 
t he i n vesti gat or bef ore tra ns mittal t o G S K C H.  It is v er y  im p orta nt 
t hat t he 
i n vesti gat or descri bes a n y c orrecti ve or re me dial actio ns ta ke n t o pre ve nt rec urre nce of 
t he i nci de nt.

T he c o m p lete d I nci de nt Re p ort F or m  sh o ul d be e maile d t o t he G S K C H Cli nical 
O perati o ns Safet y Re p orti n g e mail b o x wi t h the st u d y nu m ber a n d s u bject n u m ber i n 
t he s u bject li ne of t he e mail as s o o n as p ossi ble, b ut n ot l ater t h a n 2 4 h o urs aft er 
st u d y site pers o n nel lear n of  the e ve nt. If t here is an S A E, t he c o mplete d S A E pa ges 
s h o uld be se nt t o get her wit h t his r e p ort for m .  H o we ver, if a c o p y of t he S A E re p ort is 
se nt wit h t his f or m, t his d oes n ot re place t he pr oce d ure t o re p ort a n S A E.  T he origi nal 
I nci de nt Re p ort F or m will re mai n with t he s u bject’s rec or ds.

T he G S K C H St u d y  Ma na ger s h o uld be n otifie d of t he sit uati o n b y  t ele p h o ne or e mail.
E m ail t he I nci de nt Re p ort F or ms t o:

T he G S K C H St u d y  
Ma na ger or desi g nee will be res p o nsi ble f or f or war di n g t he 
I nci de nt Re p ort F or m t o t he Case Ma na ge me nt Gr o u p, Gl o bal Cli nical Safet y a n d 
P har mac o vi gila nce gr o u p ma il b ox 
, res p o nsi ble f or t he st u d y 
a n d ot her G S K C H pers o n nel as a p pr o priate.

T he i nitial re p ort will be f oll o we d u p wi t h mor e i nf or mati on as rele va nt, or as 
re q ueste d b y t he G S K C H st u d y ma na ger.
T he i n vesti gat or will f oll o w t he f oll owi n g directi o ns re gar di n g t he re p orti n g of  a de vice 
fail ure ( malf u ncti on):

N otif y G S K C H i m me diatel y ( b y  fol l owi n g t he pr ocess descri be d a b o ve).

Sc he d ule t he s u bject t o ret ur n t o t he site pr o m pt l y t o ret ur n t he faile d de vice.

Rec or d a n y i nci de nts o n t he C R F a n d I nci de nt Re p ort F or m  fol l owi n g i nstr uctio ns 
gi ve n i n t he sect i on a b o ve.

Ret ur n t he faile d de vice t o t he s p o ns or as s o o n as p ossi ble, i ncl u di n g d oc u me ntati o n of 
t he details of t he fail ure 
8. 8. 3
F oll o w -u p of M e di c al D e vi c e I n ci d e nt s

All me dical de vice i nci de nts i n v o l vi n g a n A E will be f oll owe d a n d re p orte d i n t he 
sa me ma n ner as ot her A Es. T his a p plies t o all partic i pa nts, i ncl u di n g t h ose w h o 
di sc o nti n ue st u d y tr e at me nt or t he st u d y.

T he i n vest i gat or is res p o nsi ble f or e ns uri n g t hat f oll o w-u p i ncl u des a n y s u p ple me ntal 
i n vesti gati ons as i n dicate d t o el uci date t he nat ure a n d/ or ca usalit y of  t he i nci de nt.

Ne w or u p date d i nf or mati o n will  be rec or de d o n t he ori gi nall y c o m p lete d f or m with 
all c ha n ges si g ne d a n d date d b y t he i n vesti gat or.
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
2 4- O ct- 2 0 1 7 0 8: 4 9: 0 5
 
2 0 8 3 9 7 Cli ni c al Pr ot o c ol 2. d o c x
el d o _ c o ntr oll e d
2. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d b 1 b 9 1
Pa ge 4 5 of 6 2
P P D
P P D

S o di u m -calci u m mi xe d partial salt of p ol y( met h yl vi n y let her/ maleic aci d) a n d car b o x y met h ylcell ul ose
2 0 8 3 9 7
Fi nal Cli nica l Pr ot oc ol, 2 0 Oct 2 0 1 7
Gla x o S mit h Kli ne C o ns u mer Healt hcare C o nfi de ntial
Te m plate Ver si o n Effecti ve: 2 2-J u n-2 0 1 7
Pa ge 4 6 of  6 2
8. 8. 4
R e g ul at or y a n d Et hi c s R e p orti n g R e q uir e m e nt s f or I n ci d e nt s

I n or der t o f ulfil re g ulat or y re p orti n g o bli gati o ns w orl d wi de, t he i n vesti gat or is 
res p o nsi ble f or t he detecti o n a n d d oc u me ntati o n of  eve nts meet i n g t he defi nit i ons of  
i nci de nt or ma lf u ncti o n t hat o c c ur d uri n g t he st u d y wi t h suc h de vices. Me dical de vice 
i nci de nts or malf u nct i ons of t he de vice t hat res ult i n a n i nci de nt will be detecte d, 
d oc u m e nte d, a n d re p orte d d uri n g all p eri o ds of  t h e st u d y in w hic h t he me dical de vice 
is use d. 

T he i n vest i gat or will pr om pt l y re p ort all i nci de nts occ urri n g wit h a n y me dical de vice 
pr o vi de d f or use i n t he st u d y  in or der f or t he s p o ns or t o f ulfil t he le gal res p o nsi bilit y t o 
n otif y a p pr o priate re g ulat or y  a ut h orities a n d ot her e ntities a b o ut certai n safety 
i nf or mat i on rel at i n g t o me dical de vices bei n g use d i n cli nical st u dies.

T he i n vesti gat or, or res p o nsi ble pers o n acc or di n g t o lo c al  re q uire me nts (e. g., t he hea d 
of  the me dical 
i nstituti o n), will 
c o mpl y wi t h the a p plica ble l ocal re g ulat or y 
re q uire me nts relat i n g t o t he re p orti n g of i nci de nts t o t he I R B/I E C.
9
D A T A M A N A G E M E N T
As use d i n t his pr ot oc ol, t he ter m C R F s h o uld be u n derst o o d t o refer t o ei t her a pa per f or m or 
a n electr o nic data rec or d or b ot h, de pe n di n g o n t he data c ollecti o n met h o d use d i n t his st u d y . 
F or t hi s st u d y s u bject data will be e ntere d i nt o a n electr o nic C R F, usi ng a vali date d s y st e m.
9. 1
S o ur c e D o c u m e nt s/ D at a
T he s o urce d oc u m e nts (e. g., h os pi t al rec or ds, cli nical a n d of fice c harts, lab orat or y n otes, 
me m ora n da, s u bjects’ diari es or e v al u atio n c hec klists, p har m ac y dis pe nsi n g rec or ds, rec or de d 
data fr o m a ut o mate d i nstr u me nts, micr ofic hes, p h ot o gra p hic ne gati ves, micr ofil m or ma g netic 
me dia, x- ra ys, s u bject files a n d rec or ds ke pt at  the p har mac y , at t he lab orat or y  an d at t he 
me dic o -tec h nical de part me nts i n v ol ve d i n t he cli nical st u d y) w hic h c o ntai n t he s o urce of d ata 
rec or de d i n t he C R F s h o uld be s pecifie d i n Sect i o n 6 .  The C R F ca n be use d as a s o urce 
d oc u m e nt at t he discreti on of data ma na ge me nt.
Eac h s u bject will be assi g ne d a n d i de ntifie d b y a u ni q ue N u m ber. A n y refere nce ma de t o a n 
i n di vi d ual s u bject wit hi n t he st u d y must be d o ne usi n g t he u ni q ue Scree ni n g N u m ber.
9. 2
C a s e R e p ort F or m
A C R F is a pri nte d, o pti c al, or electr o nic d oc u me nt desi g ne d t o rec or d all of  the pr ot oc ol 
re q uire d i nf or mat i on t o be re p orte d t o t he s p o ns or o n eac h trial s u bject.
F or eac h s u bject w h o h as gi ve n i nf or me d c o nse nt/asse nt a n d has bee n scree ne d, C R F m u st b e 
c o mplete d a n d si g ne d b y t h e Pri n ci p al I n v esti gat or ( or a ut h orise d desi g nee) t o certif y t hat t he 
data are c o m plete a n d c orrect.  
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
2 4- O ct- 2 0 1 7 0 8: 4 9: 0 5
 
2 0 8 3 9 7 Cli ni c al Pr ot o c ol 2. d o c x
el d o _ c o ntr oll e d
2. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d b 1 b 9 1
Pa ge 4 6 of 6 2

S o di u m -calci u m mi xe d partial salt of p ol y( met h yl vi n y let her/ maleic aci d) a n d car b o x y met h ylcell ul ose
2 0 8 3 9 7
Fi nal Cli nica l Pr ot oc ol, 2 0 Oct 2 0 1 7
Gla x o S mit h Kli ne C o ns u mer Healt hcare C o nfi de ntial
Te m plate Ver si o n Effecti ve: 2 2-J u n-2 0 1 7
Pa ge 4 7 of  6 2
Ma na ge me nt of  cli nical data will be p erf or m e d i n acc or dance wi t h T hir d P art y  BD M Ve n d or 
a p plica ble sta n dar ds a n d data clea ni n g pr oce d ures wi t h oversi g ht b y G S K C H t o e ns ure 
i nte grit y of t he data e. g., re m o vi n g err ors a n d i nc o nsiste ncies i n t he data.
I n or der t o pr otect t he pri vac y of  su bjects, n o Pers o nall y I d ent ifia ble I nf or matio n ( PII) 
(incl u di n g t he s u bject's na me or i nitials or f ull birt h date) is t o be rec or de d i n t he C R F or as 
part of t he q uer y  te xt.
All C R F pa ges s h o uld be c o m p lete d d uri n g a s u bject assess me nt w he n t he C R F has bee n 
desi g nate d as t he s o urc e.  Data t hat is s o urce d else w here s h o uld be e ntere d i nt o t he C R F i n a n 
a gree d u p o n ti mefra me bet wee n t he I n vest i gat or a n d S p o ns or.  
G S K C H will o btai n a n d retai n all C R Fs a n d ass ociate d st u d y data at t he c o mplet i on of  the 
st u d y. 
9. 3
D at a H a n dli n g
D oc u m e ntat i on of  all data ma na ge me nt acti vit ies s h o uld allo w ste p- b y-ste p retr os pecti ve 
assess me nt of data q ualit y a n d st u d y p erfor ma nce. 
A n y c ha n ges or c o rrecti o ns t o data will be p erf or me d i n t he El ectr o nic Data Ca pt ure ( E D C) 
S y st e m, a n d it will i ncl u de r atio nale f or c ha n ges. T he E D C s yste m has a n a u dit trail, w hic h 
will pr o vi de a c o m plete rec or d of t he c ha n ges a n d c orrecti o ns e n d orse d b y  t he I n vesti gat or.
A n y c orrectio ns t o t he e ntries ma de t o pa per s ource d oc u m e nts m ust be date d, i nitialle d, a n d 
e x plai ne d (if ne cessar y) a n d s h o uld n ot o bsc ure t he ori gi nal e ntr y . 
A d verse e ve nts will be c o de d usi n g Me d D R A ( M e dical Dict i onar y f or Re g ul at or y Act i vities) 
a n d c o nc o mit a nt me d icati ons t er ms (if a p plica ble) usi n g a n i nter nal vali date d me d icati on 
di ct i onar y , G S K Dr u g.  
9. 3. 1
Q u eri e s
Pr o gra m me d e di t c h e c ks will be ge nerate d a ut o m aticall y, as t h e d at a is b ei n g e nt er e d i nto t h e 
s yste m. Data Ma na ge me nt will als o r u n re p orts a n d listi n gs o n t he C R F data, i n a d diti on t o t he 
q ueri es alrea d y pr o gra m me d a n d ge nerate d b y t h e s yste m, t o raise ma n ual q ueries as nee de d 
f or sit e clarificat i on or c orrectio n. T he Cli nical Di ct i onar y De vel o p me nt a n d Ma na ge me nt 
Gr o u p will raise q ueries as nee de d o n safety d at a t o c o de t he t er ms ( Ad verse E ve nts a n d 
Dr u gs) a p pr o priatel y . 
T he st u d y mo ni t or at  the st u d y sit e will re vie w t he C R Fs i n acc or da nce wi t h the m o nit ori n g 
pl a n, a n d a n y q ueries will be ge nerate d i n t he E D C S y st e m to t he I n vesti gat or or desi g nee, 
e na bli n g t he err ors t o be a d dresse d i n parallel wi t h Data Ma na ge me nt re vie w. T h e st u d y 
m o nit or ca n als o r u n re p orts a n d listi n gs o n t he C R Fs, t o raise ma n ual q ueries as nee de d f or 
sit e clarificatio n or c orrecti o n.
9. 4
Pr o c e s si n g P ati e nt R e p ort e d O ut c o m e s
P ati e nt re p orte d o utc o m e ( P R O) data ma y be c o llecte d fr o m diar y car ds, q uesti o n n ai res, etc, 
a n d e ntere d i nto t he s p o ns or’s cli nical data ma na ge m e nt s yste m (D M S).  In i nsta nces w here 
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
2 4- O ct- 2 0 1 7 0 8: 4 9: 0 5
 
2 0 8 3 9 7 Cli ni c al Pr ot o c ol 2. d o c x
el d o _ c o ntr oll e d
2. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d b 1 b 9 1
Pa ge 4 7 of 6 2

S o di u m -calci u m mi xe d partial salt of p ol y( met h yl vi n y let her/ maleic aci d) a n d car b o x y met h ylcell ul ose
2 0 8 3 9 7
Fi nal Cli nica l Pr ot oc ol, 2 0 Oct 2 0 1 7
Gla x o S mit h Kli ne C o ns u mer Healt hcare C o nfi de ntial
Te m plate Ver si o n Effecti ve: 2 2-J u n-2 0 1 7
Pa ge 4 8 of  6 2
t he P R O data is e ntere d i nto t h e D M S b y G S K C H, t he P R Os will be a n o n y mise d as a gree d 
a n d d o c u m e nte d pri or t o stu d y i nitiati on. P R Os t hat are s o urce will be retai ne d b y t he 
i n vesti gat or a n d certifie d c o pies will be se nt t o G S K C H. 
I n or der t o pr otect t he pri vac y of  su bjects, n o Pers o nall y I de ntifia ble I nf or matio n ( PII) 
(incl u di n g t he s u bject's na me or i nitials or bi rt h d at e) is t o be rec or de d o n all P R O’s t hat will 
be f or war de d t o G S K C H.
All P R O s o urce data s h o uld be re vie we d b y t he st u d y staff/st u d y mo ni t or (as a p pr o priate) t o 
e ns ure t hat a n y p ot e ntial A Es re p orte d o n t hese d oc u me nts are re prese nte d i n t he D M S.
9. 5
E xt er n al D at a 
E xter nal D at a are s u bject data o btai ne d e xter nall y t o t h e C R F . T hese data are ge nerate d fr o m 
la b orat or y i nstr u me nts, c o mp uters or ot her s o urces a n d t he n tra nscri be d i nto a fil e a n d f or mat 
a gree d u p o n b y G S K C H t o ide ntif y t he su bject a n d time p oi nt r efere nce d i n t he C R F a n d/ or 
pr ot oc ol . 
A n a gree d u p o n q ualit y c o ntrol pr ocess is perf or me d a gai nst t he tra nscri be d data t o t he s o urce 
t o e ns ure t he acc urac y of  the tra nscript i on. T he tra nscri be d d at a is tra ns mitte d i n a n a gree d 
u p o n f or m at t o G S K C H. 
Rec o nciliat i on will be p erf or m e d bet wee n t he tra nscri be d data a n d t he c li nical data base t o 
e ns ure s u bject a n d ti me p oi nt refere nce d i n t he Cli nical Data base mat c h bef ore Cli nical 
Data base Freeze (l oc ki n g of t he data base) ca n occ ur.
1 0
S T A TI S TI C A L C O N SI D E R A TI O N S A N D D A T A A N A L Y S E S
1 0. 1
S a m pl e Si z e D et er mi n ati o n
Si nce t his is a n e x plor a t or y 
met h o d olo g y  de v elo p m e nt st u d y, n o f or mal sa m ple size 
calc ulat i on was c o n d ucte d.
 
 
 
 
T heref ore, a p pr o xi matel y 4 8
( ma xi m u m 5 0) heal t h y s u bjects wi t h bot h  
ma xillar y a n d 
ma n di b ular f ull de nt ures will be e nr olle d i n t his st u d y.  S u bj e ct r e cr uit me nt will be c o ntr olle d 
t o e ns ure 5 0 ± 1 0 % of  the s u bjects will be i n eac h of  the l ow a n d hi g h Ka p ur -Ol s ha n gr o u ps 
[t he l ow Ka p ur -Ols ha n gr o u p is defi ne d as a c o mp osi t e Ka p ur -Ol s ha n sc ore of  6- 1 4 
(cli nicall y fair a n d g o o d de nt ures) a n d t he hi g h Ka p ur -Ols ha n sc ore as 1 5 - 1 8 (cli nicall y ver y 
g o o d de nt ures)].
1 0. 2
St ati sti c al M et h o d s a n d A n al yti c al Pl a n
A d dit i onal details of  the pr o p ose d statistical a nal ysis will be d o c u m e nte d i n t he statistical 
a na l ysis pla n ( S A P), w hic h will be wri tte n f oll owi n g fi nalisati on of  the pr ot oc ol  an d pri or t o 
st u d y u n bli n di n g / a nal ysis (as a p pr o priate).
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
2 4- O ct- 2 0 1 7 0 8: 4 9: 0 5
 
2 0 8 3 9 7 Cli ni c al Pr ot o c ol 2. d o c x
el d o _ c o ntr oll e d
2. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d b 1 b 9 1
Pa ge 4 8 of 6 2
C CI

S o di u m -calci u m mi xe d partial salt of p ol y( met h yl vi n y let her/ maleic aci d) a n d car b o x y met h ylcell ul ose
2 0 8 3 9 7
Fi nal Cli nica l Pr ot oc ol, 2 0 Oct 2 0 1 7
Gla x o S mit h Kli ne C o ns u mer Healt hcare C o nfi de ntial
Te m plate Ver si o n Effecti ve: 2 2-J u n-2 0 1 7
Pa ge 4 9 of  6 2
1 0. 2. 1
D efi niti o n of A n al y si s P o p ul ati o n s

All assess me nts of safet y will be base d o n t he safet y  p o p ulatio n, defi ne d as all s u bjects 
w h o are ra n d o mise d a n d recei ve at least o ne d os e of  st u d y tr e at me nt d uri n g t he st u d y. 
S af et y p o p ul at i on s u m maries will be prese nte d b y  tr e at me nt recei ve d.

T he pri mar y p o p ul at i on f or efficac y assess me nt will be t he i nte nt -t o-treat (I T T) 
p o p ul at i on, defi ne d as all s u bjects w h o are ra n d o mise d, recei ve t he st u d y treat me nt at 
least o nce a n d pr o vi de at least o ne assess me nt of efficac y.

T he P P p o p ul at i on i ncl u des all s u bjects w h o f ull y c o m p l y wi t h all st u d y pr oce d ures 
a n d restricti o ns.
1 0. 2. 2
E x cl u si o n of D at a f r o m A n al y si s 
E xcl usi o n of  an y d at a fr om t he a nal yses will be deter mi ne d d uri n g a Bli n d D at a Re vie w 
Meet i n g pri or t o data base loc k. A n y reas o ns f or e xcl usi o n f r o m a n a nal ysis p o p ulat i on will be 
liste d, if a p plica ble.
T he Per Pr ot oc ol ( P P) p o p ulat i on will b e a s u bset of t he I T T p o p ulat i on. 
S u bjects wit h a pr ot oc ol vi o lati on t hat is dee me d t o affect efficac y f or all efficac y assess me nts 
will be e xclu de d fr o m t he P P p o p ul at i on. S u bjects wi t h a pr ot oc ol vi olati on t hat is dee me d t o 
affect efficac y for o nl y  so m e ( but n ot all) of  the efficac y assess me nts will be part of  the P P 
p o p ul at i on, b ut t heir data will be e xcl u de d fr o m t he assess me nt at w hic h t he pr ot oc ol vi olat i on 
occ urre d. A P P a nal ysis will be p erf or m e d o nl y if 1 0 % or m o re I T T s u bjects are e xcl u de d 
fr om P P p o p ul at i on. 
1 0. 2. 3
D e m o gr a p hi c a n d B a s eli n e C h ar a ct eri sti c s
Descri pt i ve st atistics ( n u m ber of  su bjects, mea n, sta n dar d de viati o n, me dia n, mi ni m u m a n d 
ma xi m u m f or c o nt i n u o us v ari a bles, a n d fre q ue nc y a n d perce nta ge f or cate g orical varia bles) 
will be pr o vi de d f or d e m o gra p hic a n d baseli ne c haracteristics. Me dical hist or y  an d c urre nt 
me dical c o n dit i ons will be liste d.
1 0. 2. 4
Tr e at m e nt s ( st u d y dr u g/ pr o d u ct, r e s c u e m e di c ati o n, ot h er 
c o n c o mit a nt t h er a pi e s, c o m pli a n c e)
Pri or me d icati ons, c o nc o mit a nt me d icati ons a n d sig nifica nt n o n- dr u g t hera pies ta ke n d uri n g 
treat me nt will be liste d f or t he safety p o p ul at i on. C o m plia nce t o t he st u d y pr o d ucts will als o  
be s u m marise d.
1 0. 2. 5
Pri m ar y A n al y si s
F o o d occl usi o n  will be meas ure d b y wei g ht of  pea n ut parti cles ( mass of  retrie ve d pea n uts i n
gr a m s). Descri pti ve st atistics (Ra w mea ns, sta n dar d de viat i ons, sta n dar d err ors, mi ni m u m  a nd 
ma xi m u m val ues) of  c o m bi ne d masses of  pea n uts rec o vere d fr om ma n di b ular a n d ma xillar y 
de nt ures a n d t heir ass ociate d ga uzes will be pr o vi de d b y  tr e at me nt gr o u p.
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
2 4- O ct- 2 0 1 7 0 8: 4 9: 0 5
 
2 0 8 3 9 7 Cli ni c al Pr ot o c ol 2. d o c x
el d o _ c o ntr oll e d
2. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d b 1 b 9 1
Pa ge 4 9 of 6 2

S o di u m -calci u m mi xe d partial salt of p ol y( met h yl vi n y let her/ maleic aci d) a n d car b o x y met h ylcell ul ose
2 0 8 3 9 7
Fi nal Cli nica l Pr ot oc ol, 2 0 Oct 2 0 1 7
Gla x o S mit h Kli ne C o ns u mer Healt hcare C o nfi de ntial
Te m plate Ver si o n Effecti ve: 2 2-J u n-2 0 1 7
Pa ge 5 0 of  6 2
1 0. 2. 6
S af et y A n al y si s
All A Es will be c o de d usi n g Me d D R A. A Es will be cate g orise d as or al  an d n o n- or al  by t he
Cli nical Researc h Di r e ct or/ Scie nt ist or desi g nee pri or t o data base l oc k. Treat m e nt -e mer ge nt 
a d verse e ve nt ( Oral AEs as w ell as all A Es) will be ass oci at e d with t he m o st r e c e nt tr e at me nt 
recei ve d. T he n u m ber of A Es a n d n u m ber of s u bjects wit h AEs will be liste d a n d ta b ulate d b y 
treat me nt. T he res ults of O S T e xa ms will be liste d. I nci de nts will be liste d.
1 0. 2. 7
Ot h er A n al y s e s
Descri pt i ve st atistics (Ra w mea ns, 
sta n dar d
de viati ons, sta n dar d err ors, mi ni m u m 
a n d 
ma xi m u m v al ues) of  masses of  pea n uts rec o vere d fr om ma n di b ular, ma xillar y  an d c o m bi ne d 
de nt ures will be pr o vi de d b y treat me nt gr o u p.
Descri pt i ve st atistics (Ra w mea ns, 
sta n dar d de viat i ons, sta n dar d err ors, mi ni m u m 
a n d 
ma xi m u m val ues) of  c o m bi ne d masses of  pea n uts rec o vere d fr om ma n di b ular a n d ma xillar y 
de nt ures will be pr o vi de d b y tr e at me nt gr o u p i n l ow a n d hi g h Ka p ur -Ols ha n gr o u ps of 
s u bjects.
Descri pt i ve st atistics (Ra w mea ns, 
sta n dar d de viat i ons, sta n dar d err ors, mi ni m u m 
a n d 
ma xi m u m val ues) will als o be pr o vi de d f or t he n u m ber of de nt ure di slo d ge me nts b y treat me nt 
gr o u p. Mass of  pea n uts will als o be pl ott e d a gai nst t he n u m ber of  disl o d ge me nts o verall a n d 
b y tr e at me nt gr o u p.
F or t he s u bjects’ res p o nses t o q uesti o n n aires, descri pt i ve st atistics ( nu m ber of  su bjects a n d 
perce nta ges) will be pr o vi de d f or eac h q uesti o n b y treat me nt gr o u p.
1 0. 2. 8
A d diti o n al A n al y s e s
F or f ut ure de vel o p me nt w or k, 
a djuste d mea ns 
of  masses 
of  pea n uts rec o vere d fr om 
ma n di b ular, ma xillar y a n d c o m bi ne d
de nt ures , al o n g wi t h 95 % c o nfi de nce i nter val will als o 
be re p orte d b y tr e at me nt gr o u p. T hese will be deri ve d fr om a mi xe d m o del wi t h perio d a n d 
treat me nt as fi xe d effects a n d s u bject as a r a n d o m effect. Treat me nt differe nces a n d 9 5 % 
c o nfi de nce i nter vals o f treat me nt differe nces will be re p orte d .
Usi n g t he sa me m o del as a b o ve, a s u b gr o u p a nal ysis will  be als o c o n d ucte d i n l ow a n d hi g h 
Ka p ur -Ols ha n gr o u ps of  su bjects . A d j uste d mea ns of  c o m bi ne d masses of  pea n uts rec o vere d 
fr om ma n di b ular a n d ma xillar y de nt ur e, alo n g wi t h 95 % c o nfi de nce i nter val will b e re p orte d 
b y treat me nt gr o u p s f or eac h s u b-gr o u p.
T hese res ults will be re p orte d i n t he statistical a p pe n di x as part of t he C S R.
1 0. 2. 9
H a n dli n g of Dr o p o ut s a n d Mi s si n g D at a 
S u bjects w h o wi t hdra w fr o m t he st u d y earl y will be i ncl u de d i n t he st u d y anal ysis u p t o t he 
p oi nt of  wit hdra wal. S u bjects w h o wi t hdra w will n ot be r e place d. N o data will be i m p ute d i n 
t he case of dr o p o uts or missi n g data.
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
2 4- O ct- 2 0 1 7 0 8: 4 9: 0 5
 
2 0 8 3 9 7 Cli ni c al Pr ot o c ol 2. d o c x
el d o _ c o ntr oll e d
2. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d b 1 b 9 1
Pa ge 5 0 of 6 2

S o di u m -calci u m mi xe d partial salt of p ol y( met h yl vi n y let her/ maleic aci d) a n d car b o x y met h ylcell ul ose
2 0 8 3 9 7
Fi nal Cli nica l Pr ot oc ol, 2 0 Oct 2 0 1 7
Gla x o S mit h Kli ne C o ns u mer Healt hcare C o nfi de ntial
Te m plate Ver si o n Effecti ve: 2 2-J u n-2 0 1 7
Pa ge 5 1 of  6 2
1 0. 2. 1 0
I nt eri m A n al y si s 
N o i nt eri m a nal ysis is pla n ne d f or t his st u d y.
1 1
S T U D Y G O V E R N A N C E C O N SI D E R A TI O N S
1 1. 1
Q u alit y C o ntr ol 
I n acc or da nce wi t h a p plica ble re g ulati ons i ncl u di n g G C P, a n d G S K pr oce d ures, G S K or 
desi g nee (i.e. t hir d part y  ve n d or) mo ni t ors will c o ntact t he sit e prior t o t he start of t he st u d y  t o 
re vie w wi t h t he sit e staff t he pr ot o c ol , st u d y re q uire me nts, a n d t heir res p o nsi bilities t o s atisf y 
re g ulat or y, et hical, a n d G S K re q uire me nts.
W he n 
re vie wi n g data c ollecti o n pr oce d ures, t he disc ussi o n will 
i ncl u de i de ntificati on, 
a gree me nt a n d d oc u me ntati o n of  data ite ms f or w hic h t he C R F will ser ve as t he s o urce 
d oc u m e nt.
G S K or desi g nee will m o nit or t he st u d y  a n d site acti vit y t o verif y t hat t he:

Data are a ut he ntic, acc urate, a n d c o m plete.

S af et y a n d rig hts of  s u bjects are bei n g pr otecte d.

St u d y  is c o n d ucte d i n acc or da nce wi t h the c urre ntl y a p pr o ve d pr ot oc ol  an d a n y ot h er 
st u d y a gree me nts, G C P, a n d all a p plica ble re g ulat or y re q uire me nts.
T he e xte nt a n d nat ure of  mo ni t ori n g will  be descri be d i n a wri tte n m o nit ori n g pl a n o n file at 
G S K C H. T he i n vesti gat or ( or desi g nee) a grees t o all o w t he m o nit or direct access t o all 
r ele va nt d oc u m e nts a n d a grees t o c o -o perate wit h t he m o nit or t o e ns ure t hat a n y pr o bl e ms 
detecte d i n t he c o urse of t hese m o nit ori n g visit s are res ol ve d.
1 1. 2
Q u alit y A s s ur a n c e
T o e ns ure c o mplia nce wi t h GC P a n d all a p plica ble re g ulat or y re q uire me nts, G S K ma y 
c o n d uct a q ualit y ass ura nce assess me nt a n d/ or a u dit of  the sit e rec or ds, a n d t he re g ulat or y 
a ge ncies ma y c o n d uct a re g ulat or y ins pect i on at a n y time d uri n g or aft er c o mpleti o n of  the 
st u d y. 
I n t he e ve nt of a n assess me nt, a u dit or i ns pectio n, t he i n vest i gat or (a n d i nstituti o n) m ust a gree 
t o gra nt t he a d vis or(s), a u dit or(s) a n d i ns pect or(s) direct access t o all rele va nt d oc u m e nts a n d 
t o all ocate t heir time a n d t he time of  their staff t o disc uss t he c o n d uct of  the st u d y, a n y 
fi n di n gs/rele va nt iss ues a n d t o i m ple me nt a n y c orrecti ve a n d/ or pre ve ntati ve a ctio ns t o 
a d dress a n y fi n di n gs/iss ues i de ntifie d.
T he i n vest i gat or(s) will n otif y G S K C H or its a ge nts i m me diatel y of a n y re g ulat or y ins pecti o n 
n otificati o n i n relati on t o t he st u d y. F urt her m or e, t he i n vesti gat or will c o o perate wit h G S K 
C H or its a ge nts t o pre pare t he st u d y site f or t he i ns pecti on a n d will allo w G S K C H or its 
a ge nt, w he ne ver feasi ble, t o be prese nt d uri n g t he i ns pecti on. T he i n vesti gat or will pr o m pt l y 
a p pl y c o pies of t he i ns pecti o n fi n di n g t o G S K C H or its a ge nt. Before res p o nse s u b missi o n  t o 
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
2 4- O ct- 2 0 1 7 0 8: 4 9: 0 5
 
2 0 8 3 9 7 Cli ni c al Pr ot o c ol 2. d o c x
el d o _ c o ntr oll e d
2. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d b 1 b 9 1
Pa ge 5 1 of 6 2

S o di u m -calci u m mi xe d partial salt of p ol y( met h yl vi n y let her/ maleic aci d) a n d car b o x y met h ylcell ul ose
2 0 8 3 9 7
Fi nal Cli nica l Pr ot oc ol, 2 0 Oct 2 0 1 7
Gla x o S mit h Kli ne C o ns u mer Healt hcare C o nfi de ntial
Te m plate Ver si o n Effecti ve: 2 2-J u n-2 0 1 7
Pa ge 5 2 of  6 2
t he re g ulat or y aut h ori t y, t he i n vesti gat or will pr o vi de G S K C H or its a ge nts wi t h a n 
o p p ort u nit y t o re vie w a n d c o m me nt o n res p o nses t o a n y s uc h fi n di n gs. 
T he s p o ns or will be a vaila ble t o hel p i n vesti gat ors pre pare f or a n i ns pecti o n.
1 1. 3
R e g ul at or y a n d Et hi c al C o n si d er ati o n s
As per t he Re g ulat or y  Deter mi nati on f or t his st u d y, t he de nt ure a d hesi ve pr o d uct t o be use d i n 
t his st u d y is alr e a d y mar kete d i n t he U S. T he st u d y is n ot i nte n de d t o assess safety a n d 
efficac y, t ho u g h safety is a sec o n dar y object i ve i n t hat treat me nt e mer ge nt A Es will b e 
c ollecte d, as per a n y cli nical st u d y. We d o n ot a ntici pate a n y ris k ass ociate d wi t h the use of 
t he s yrin ge f or a d hesi ve a p plicati o n i nstea d of  ap pl yi n g di rectl y fr om t u be as d o ne f or t he 
mar kete d pr o d uct. As s uc h, t his st u d y is a n ID E e xe m pt me d ical de vice st u d y as p er 2 1 C F R 
8 1 2. 2(c)( 1) a n d 2 1 C F R 8 1 2. 2(c)( 4). T hi s st u d y d o es not r e q ui re re g ulat or y a p pr o val pri or t o 
c o n d ucti n g t he st u d y.
1 1. 3. 1
I n stit uti o n al R e vi e w B o ar d 
It is t he res p o nsi bility of  the i n vesti gat or t o ha ve pr os pecti ve a p pr o val of t he st u d y pr ot oc ol , 
pr ot oc ol  a me n d me nts, i nf or me d c o nse nt d oc u m e nts, safet y state me nt (incl u di n g a n y u p dates) 
a n d ot h er r ele va nt d oc u me nts, e. g., recr uit me nt a d vert ise me nts, if a p plica ble, fr om t he I R B.  
All c orres p o n de nce wi t h the I R B s h o uld be retai ne d i n t he i n vesti gat or file.  Co pi es of I R B 
a p pr o vals s h o uld be f or war de d t o G S K C H pri or t o t h e i nitiati on of t he st u d y, a nd als o w he n 
s u bse q ue nt a me n d me nts t o t he pr ot oc ol are ma de.
T he o nl y circ u msta nce i n w hic h a n a me n d me nt ma y be i nit iate d pri or t o I R B a p pr o val is 
w here t he c ha n ge is necessar y  t o eli mi nate a p pare nt i m me diate hazar ds t o t he s u bjects.  I n t hat 
e ve nt, t he i n vesti gat or m ust n otif y t he I R B a n d G S K C H i n wri tin g i m me diatel y aft er t he 
i m ple me ntati o n.
1 1. 3. 2
Et hi c al C o n d u ct of t h e St u d y
T he st u d y will be c o n d ucte d i n acc or da nce wi t h le g al a nd re g ulat or y re q uire me nts, as well as 
t he ge neral  princi ples set f ort h in t he I nter natio nal Et hical G ui deli nes f or Bi o m e dical 
Researc h I n v ol vi n g H u ma n S u bjects ( C o u ncil f or I nter nati o nal Or ga nizat i ons of  
Me dical 
S ci e nces 2 0 0 2), g ui deli nes f or G C P ((I C H, 1 9 9 6 ) a n d re visi on 2), a n d t he Declarat i on of 
Helsi n ki ( (W o rld Me dical Ass oci at io n, 2 0 0 8 )). 
I n a d diti on, t he st u d y  will be c o n d ucte d i n acc or da nce wit h t he pr ot oc ol, t he I C H g ui deli ne o n 
G C P, a n d a p plica ble l ocal re g ulat or y  re q uire me nts a n d la ws.
1 1. 3. 3
S u bj e ct I nf or m ati o n a n d C o n s e nt
All p arti es will e ns ure pr otecti o n of  su bject pers o na l data a n d will n ot i ncl u de s u bject na mes 
or ot her i de ntifia ble d at a i n a n y re p orts, p u blicati o ns, or ot her di sclos ures, e xce pt w here 
re q uire d b y la ws. 
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
2 4- O ct- 2 0 1 7 0 8: 4 9: 0 5
 
2 0 8 3 9 7 Cli ni c al Pr ot o c ol 2. d o c x
el d o _ c o ntr oll e d
2. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d b 1 b 9 1
Pa ge 5 2 of 6 2

S o di u m -calci u m mi xe d partial salt of p ol y( met h yl vi n y let her/ maleic aci d) a n d car b o x y met h ylcell ul ose
2 0 8 3 9 7
Fi nal Cli nica l Pr ot oc ol, 2 0 Oct 2 0 1 7
Gla x o S mit h Kli ne C o ns u mer Healt hcare C o nfi de ntial
Te m plate Ver si o n Effecti ve: 2 2-J u n-2 0 1 7
Pa ge 5 3 of  6 2
W he n st u d y data are c o m p ile d f or tra nsfer t o G S K C H a n d ot h er a ut h orize d parti es, s u bject 
na mes, a d dresses, a n d ot her i de ntifia ble data will be re place d b y n u merical c o des base d o n a 
n u m beri n g s yste m pr o vi de d b y  G S K C H i n or der t o de-i de ntif y st u d y s u bjects.  
T he st u d y site will mai ntai n a c o nfi de nt ial list of  su bjects w h o partici pate d i n t he st u d y, 
li n ki ng eac h s u bject’s n u merical c o de t o his or her act ual i de ntity.   In case of  data tra nsfer, 
G S K C H will mai ntai n hi g h sta n dar ds of  co nfi de nt iality a n d pr otecti o n of  su bjects’ pers o nal 
data c o nsiste nt wit h a p plica ble pri vac y la ws.
T he i nf or me d c o nse nt d oc u m e nts m u st be i n c o m plia nce wi t h IC H G C P, l ocal re g ulat or y 
re q uire me nts, a n d le gal re q uire me nts, i ncl u di n g a p plica ble pri vac y la ws.
T he i nf or me d c o nse nt d oc u me nts use d d uri n g t he i nf or me d c o nse nt pr ocess m ust be re vie we d 
a n d a p pr o ve d b y t he s p o ns or, a p pr o ve d b y t he I R B/ E C bef ore use, a n d a vaila ble f or 
i ns pecti o n.
T he i n vesti gat or m u st e ns ure t hat eac h st u d y su bject, is full y i nf or me d a b o ut t he nat ure a n d 
o bj ect i ves of t he st u d y a n d p ossi ble ris ks ass ociate d wit h partici pati on. 
T he i n vesti gat or, or a pers o n de sig nate d b y t he i n vesti gat or, will o btai n wri tte n i nf or me d 
c o nse nt fr o m eac h s u bject bef ore a n y st u d y-s pecific acti vit y is p erf or m e d.  The i n vesti gat or 
will retai n t he ori gi nal o f eac h s u bject's si g ne d i nf o r me d c o nse nt d oc u me nt.
1 1. 3. 4
S u bj e ct R e cr uit m e nt 
A d vert ise me nts a p pr o ve d b y I R Bs a n d i n vesti gat or data bases ma y be use d as recr uit me nt 
pr oce d ures.   Use of I R B a p pr o ve d, ge neric, pre- scree ni n g q uesti o n naire t o assess basic s u bject 
c haracterist ics t o deter mi ne ge neral eli gi bilit y f or t his st u d y is allo we d.
T his ge neric 
q uesti o n naire ma y be use d b y sit es as a p h o ne s cript a n d/ or t o re vie w i nter nal data bases t o 
i de ntif y s u bjects.  
G S K C H will ha ve a n o p p ort u ni t y t o re vie w a n d a p pr o ve t he c o nte nt of a n y st u d y recr uit me nt 
materi als directe d t o p ote ntial st u d y s u bjects bef ore s uc h materials are use d. 
1 1. 3. 5
R e p orti n g of S af et y I s s u e s a n d S eri o u s Br e a c h e s of t h e Pr ot o c ol or 
I C H G C P 
Wit hi n a G S K C H a serio us breac h is defi ne d as a breac h li kel y t o affect t o a sig nifica nt 
de gree t he safet y  a nd ri g hts of  a s u bj e ct or t he relia bilit y a nd r o b ust ness of t he data ge nerate d 
i n G S K C H- s p o ns ore d h u ma n s u bject researc h st u dies. 
I n t he e ve nt of  an y pr o hi bit i on or restrict i on i m p ose d (i.e., cli nical h o l d) b y a n a p plica ble 
c o mpete nt a ut h orit y in a n y area of  the w orl d, or if t he in vest i gat or is aware of  an y ne w 
i nf or mat i on t hat mi g ht i nfl ue nce t he e val uati on of  t he be nefits a nd ris ks of  t he i n vesti gati onal 
pr o d uct, G S K C H s h o ul d be i nf or me d i m me diatel y. 
I n a d ditio n , t he i n vesti gat or will i nf or m G S K C H i m me diatel y of  a n y ur ge nt safet y meas ures 
ta ke n b y t he i n vesti gat or t o pr otect t he st u d y su bjects a gai nst a n y i m me diate hazar d, a n d of  
a n y seri o us breac hes of t his pr ot oc ol or of I C H G C P t hat t he i n vest i gat or bec o mes a ware of.
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
2 4- O ct- 2 0 1 7 0 8: 4 9: 0 5
 
2 0 8 3 9 7 Cli ni c al Pr ot o c ol 2. d o c x
el d o _ c o ntr oll e d
2. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d b 1 b 9 1
Pa ge 5 3 of 6 2

S o di u m -calci u m mi xe d partial salt of p ol y( met h yl vi n y let her/ maleic aci d) a n d car b o x y met h ylcell ul ose
2 0 8 3 9 7
Fi nal Cli nica l Pr ot oc ol, 2 0 Oct 2 0 1 7
Gla x o S mit h Kli ne C o ns u mer Healt hcare C o nfi de ntial
Te m plate Ver si o n Effecti ve: 2 2-J u n-2 0 1 7
Pa ge 5 4 of  6 2
1 1. 4
P o sti n g of I nf or m ati o n o n P u bli cl y A v ail a bl e Cli ni c al Tri a l 
R e gi st er s
St u d y  inf or mat i on fr om t his pr ot oc ol will be p oste d o n p u blicl y a vaila ble cli nical trial 
r e gisters bef ore e nr ol me nt of s u bjects be gi ns i n acc or da nce wit h a p plica ble G S K pr ocesses.
1 1. 5
Pr o vi si o n of St u d y R e s ult s t o I n v e sti g at or s
W here 
re q uir e d b y a pplica ble re g ulat or y re q uire me nts, a n i n vesti gat or sig nat or y will be 
i de ntifie d f or t he a p pr o val of  the cli nical st u d y re p ort.  The i n vesti gat or will be pr o vi de d 
reas o na ble access t o statistical ta bles, fi g ures, a n d rele va nt re p orts a n d will ha ve t he 
o p p ort u nit y t o re vie w t he c o mplete st u d y res ults at a G S K sit e or ot her m ut uall y -a greea ble 
l ocat i on.
G S K will als o pr o vi de t he i n vesti gat or wit h t he f ull s u m mar y of t he st u d y res ults.  The 
i n vesti gat or is e nc o ura ge d t o s hare t he s u m mar y res ults wi t h the st u d y su bjects, as 
a p pr o priate.
T he pr oce d ures a n d timi n g f or p u blic discl os ure of t he r es ults s u m mar y a n d f or de vel o p me nt 
of  a ma n uscript f or p u blicat i on will be i n acc or da nce wit h G S K P olic y.
A ma n uscri pt will be pr o gresse d f or p u blicat i on i n t he scie ntific literat ure if t he r es ults 
pr o vi de i m p orta nt sci e nt ific or me dical k n o wle d ge.
1 1. 6
R e c or d s R et e nti o n
F o ll owi n g clos ure of  the st u d y, t he i n vesti gat or m ust mai ntai n all sit e st u d y rec or ds (e xce pt 
f or t hose re q uir e d b y l ocal re g ulati ons t o be mai ntai ne d else w here), i n a s afe a n d sec ure 
l ocat i on.  
T he rec or ds (st u d y/ sit e master file) m ust be mai ntai ne d t o all o w eas y a n d timel y r etrie val, 
w he n nee de d (e. g., f or a G S K a u di t or r e g ulat or y i ns pect i on) a n d m ust be a vaila ble f or re vie w 
i n c o nju n cti o n wi t h assess me nt of t he facilit y, s u p p orti n g s yste ms, a n d rele va nt site staff.
W here per mi tt e d b y l ocal la ws/re g ulati o ns or i nstit uti o nal p olic y, s o me or all of t h es e r e c or ds 
ca n be mai ntai ne d i n a f or mat ot h er t ha n har d c o p y (e. g., micr ofic he, sca n ne d, electr o nic); 
h o we ver, ca ut i on nee ds t o be e xercise d bef ore s uc h act i on is ta ke n. 
T he i n vesti gat or m ust e ns ure t hat all re pr o d uctio ns are le gi ble a n d are a tr ue a n d acc urate 
c o p y of t he ori gi nal a n d meet accessi bilit y a n d r etrie val sta n dar ds, i ncl u di n g re-ge nerat i n g a 
har d c o p y , if re q uir e d.  F urt h er mor e, t h e i n vesti gat or must e ns ure t here is a n acce pta ble bac k -
u p of  these re pr o d uctio ns a n d t hat a n acce pta ble q ualit y c o ntr ol pr ocess e xists f or ma ki n g 
t hese re pr o d ucti o ns.
T he i n vesti gat or m ust ass ure t hat t he s u bject’s a n o n y mit y will be mai ntai ne d.  On C R Fs or 
ot her d oc u me nts s u b mitte d t o G S K C H, s u bjects s h o uld n ot be i de ntifie d b y t heir na mes or 
i nitials, b ut b y a n i de ntificati on c o de. T he i n vesti gat or s h o uld k e e p a se parate l og of  su bjects’ 
c o des, na mes a n d a d dresses.  Do c u m e nts n o t f or s u b missi on t o G S K C H, e. g. s u bjects’ 
wri tte n c o nse nt f or ms, s h o ul d be mai ntai ne d b y t he i n vesti gat or i n strict c o nfi de nce.
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
2 4- O ct- 2 0 1 7 0 8: 4 9: 0 5
 
2 0 8 3 9 7 Cli ni c al Pr ot o c ol 2. d o c x
el d o _ c o ntr oll e d
2. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d b 1 b 9 1
Pa ge 5 4 of 6 2

S o di u m -calci u m mi xe d partial salt of p ol y( met h yl vi n y let her/ maleic aci d) a n d car b o x y met h ylcell ul ose
2 0 8 3 9 7
Fi nal Cli nica l Pr ot oc ol, 2 0 Oct 2 0 1 7
Gla x o S mit h Kli ne C o ns u mer Healt hcare C o nfi de ntial
Te m plate Ver si o n Effecti ve: 2 2-J u n-2 0 1 7
Pa ge 5 5 of  6 2
Rec or ds a n d d oc u m e nts, i ncl u di n g si g ne d I C F, pertai ni n g t o t he c o n d uct of t his st u d y must be 
retai ne d b y t he i n vesti gat or f or 2 5 years fr om t he iss ue of  the fi nal Cli nical St u d y Re p ort 
( C S R)/ e q ui vale nt s u m mar y u nless l ocal re g ulati ons or i nstituti o nal  pol icies re q uire a l on ger 
rete ntio n p eri o d. T he mi ni m u m rete ntio n ti me will meet t he strictest sta n dar d a p plica ble t o 
t hat sit e f or t he st u d y, as dictate d b y a n y insti t utio nal re q uire me nts or l ocal la ws or 
re g ulat i ons, G S K sta n dar ds/ pr oce d ures, a n d/ or i nstit ut i onal re q uire me nts.  
N o stu d y d o c u m e nt s h o uld be destr o ye d wi t ho ut a  prior wri tte n a gree me nt bet wee n G S K C H 
a n d t he i n vesti gat or. T he i n vesti gat or m ust n otif y G S K of  an y c ha n ges i n t he arc hi val 
arra n ge me nts, i ncl u di n g, b ut n ot li mite d t o, arc hi val at a n off -sit e facilit y or tra nsfer of 
o w ners hi p of t he rec or ds i n t he e ve nt t he i n vesti gat or is n o l o n ger ass ociate d wit h t he site.
1 1. 7
C o n diti o n s f or T er mi n ati n g t h e St u d y 
Pr e m at ure ter mi nati on of  this st u d y ma y occ ur beca use of  a re g ulat or y aut h ori t y decisio n , 
c ha n ge i n o pi ni o n  of t he I R B/ E C, or i n vesti gati o nal pr o d uct safety pr o bl e ms, or at t he 
di scretio n of  GS K  CH.  I n ad di tio n , G S K C H retai ns t he rig ht t o disc o nti n ue d e v el o p me nt of  
de nt ure a d hesi ves at a n y  ti me.  
If a st u d y is pre mat urel y  ter mi nate d, G S K C H will pr o m pt l y n otif y t he i n vesti gat or.  After 
n otificati o n, t he i n vesti gat or m u st pr o m pt l y c o ntact all partici pati n g s u bjects a nd s h o uld 
ass ure a p pr o priate t hera p y/ f oll o w- u p f or t he s u bjects.  As directe d b y G S K C H, all st u d y 
materi als m ust be c o llecte d a n d all C R Fs c o m p lete d t o t he greatest e xte nt p ossi ble. W here 
re q uire d b y t he a p plica ble re g ulat or y re q uire me nts, G S K C H s h o uld i nf or m  the re g ulat or y 
a ut h orit y(ies) a n d t h e i n vesti gat or s h o uld pr o m pt l y i nf or m t he I R B a n d pr o vid e t h e I R B/ E C a 
detaile d writte n e x pla nat i on of t he ter mi nat i on or s us pe nsi o n. 
If t he I R B/ E C ter mi nates or s us pe n ds its a p pr o val/fa v o ura ble o pi ni o n  of a trial, t he 
i n vesti gat or s h o uld pr o m pt l y n otif y t he G S K C H a n d pr o vi de G S K C H wi t h a detaile d writte n 
e x pla nat i on of t he ter mi nat i on or s us pe nsi o n.
U p o n c o mplet i on or pr e m at ure di sc o nti n uati on of  the st u d y, t he G S K C H m o nit or will 
c o n d uct sit e clos ure acti vit ies wi t h t he i n vesti gat or or sit e staff, as a p pr o priate, i n acc or da nce 
wi t h a p plica ble re g ulati ons i ncl u di n g G C P, a n d G S K C H Sta n dar d O perati n g Pr oce d ures.
1 1. 8
D efi niti o n of St u d y E n d/ E n d of St u d y 
T he e n d of t he st u d y  will be t he date of t he Last S u bject Last Vi sit ( L S L V).  F or t his st u d y t he 
L S L V date will be t he pri mar y c o m p leti o n date ( P C D).
1 2
R E F E R E N C E S
2 0 5 9 1 5, G S K Cli nical St u d y  Re p ort, A Cli nical St u d y  to E val uate t he A bilit y of  an 
E x peri me ntal De nt ure A d hesi ve t o Pre ve nt F o o d Parti cle I ngress u n der De nt ures. G S K Data 
H el d o n File; 2 0 1 6.
A h ma d M, 
I bra hi m D F A, Haz mi  NH, Tari b N A, Ka mar u di n K H. T he Ef fect of  De nt ure 
A d hesi ve o n F o o d Occl usi o n. Mala ysia n De nt. J. 2 0 0 9; 3 0( 2): 1 4 6 - 7.
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
2 4- O ct- 2 0 1 7 0 8: 4 9: 0 5
 
2 0 8 3 9 7 Cli ni c al Pr ot o c ol 2. d o c x
el d o _ c o ntr oll e d
2. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d b 1 b 9 1
Pa ge 5 5 of 6 2

S o di u m -calci u m mi xe d partial salt of p ol y( met h yl vi n y let her/ maleic aci d) a n d car b o x y met h ylcell ul ose
2 0 8 3 9 7
Fi nal Cli nica l Pr ot oc ol, 2 0 Oct 2 0 1 7
Gla x o S mit h Kli ne C o ns u mer Healt hcare C o nfi de ntial
Te m plate Ver si o n Effecti ve: 2 2-J u n-2 0 1 7
Pa ge 5 6 of  6 2
A h ma d M, I bra hi m D F A, Haz mi N H, Tari b N A, Ka mar u di n K H. A n In vest i gati on i nto t he 
Effect 
of  
De nt ure A d hesi ves 
i n Li mit i n g t he F o o d I mp a cti o n. Mala ysia n 
De nt. 
J. 
2 0 1 0; 3 1( 2): 6 5 - 7 0.
F D A U. G ui da nce f or I n d ustr y: C o llecti on of  Race a n d Et h nicit y D at a i n Cli nical Tri als. 
2 0 0 5.
I C H. T o pic 6 G uideli ne f or G o o d Cli nical Pr act ice C p m p/Ic h/ 1 3 5/ 9 5. 1 9 9 6.
Ka p ur K K. A Cli nical E val uat i on of De nt ure A d hesi ves. J. Pr ost het. De nt. 1 9 6 7; 1 8( 6): 5 5 0- 8.
 
 
 
 
M u n oz -Vi ver os C, Sc h o ber N, Ca m pill o M, G o nser F, S ha n ga G, Ma g n usze ws ki T, et al. 
De nt ure A d hesi ve Re d uce d F o o d E ntra p m e nt u n der Re m o v a ble P arti al De nt ures. J. De nt. 
Res. 2 0 1 0; 9 0( S pec Iss A): A bstract 1 0 5 3.
M u n oz -Vi ver os C, T ys o n -J o h ns o n D, Fer na n dez P, Ca m pill o M, S ha n ga G, Ge n drea u L, et al. 
De nt ure A d hesi ve Re d uce d F o o d E ntra p m e nt u n der Re m o va ble F ull De nt ures. J. De nt. Res. 
2 0 1 0; 9 0( S pec Iss A): A b stract 1 0 5 2.
M u n oz C A, Ge n drea u L, S ha n ga G, Ma g n usze ws ki T, Fer na n dez P, D ur oc her J. A Cli nica l 
St u d y  to E val uate De nt ure 
A d hesi ve 
Use 
i n Well  Fi tti n g De nt ures. 
J. Pr ost h o d o nt. 
2 0 1 2; 2 1( 2): 1 2 3 - 9.
Ol s ha n A, R oss N, Ma n k o di S, Melita S. A M o difie d Ka p ur Scal e f or E val uat i n g De nt ure 
Rete nti o n a n d Sta bilit y: Met h o d ol o g y  St u d y. A m. J. De nt. 1 9 9 2; 5( 2): 8 8- 9 0.
Özca n M, 
K u la k Y, De B a at C, Ar i ka n A, Uca n kale M. 
T h e Ef fect of  a Ne w De nt ure 
A d hesi ve o n Bite F orce u ntil De nt ure Disl o d ge me nt. J. Pr ost h o d o nt. 2 0 0 5; 1 4( 2): 1 2 2 -6.
 
S al da n ha 
S, 
S h e n o y 
V K, 
Eac ha m pat i 
P, 
U p pal 
N. 
De ntal  
Im p licati ons 
of  
Bis p h o p h o nate  Rel ate d Oste o necr osis. Ger o do nt ol o g y . 2 0 1 2; 2 9( 3): 1 7 7- 8 7.
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
2 4- O ct- 2 0 1 7 0 8: 4 9: 0 5
 
2 0 8 3 9 7 Cli ni c al Pr ot o c ol 2. d o c x
el d o _ c o ntr oll e d
2. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d b 1 b 9 1
Pa ge 5 6 of 6 2
C CI
C CI
C CI
C CI

S o di u m -calci u m mi xe d partial salt of p ol y( met h yl vi n y let her/ maleic aci d) a n d car b o x y met h ylcell ul ose
2 0 8 3 9 7
Fi nal Cli nica l Pr ot oc ol, 2 0 Oct 2 0 1 7
Gla x o S mit h Kli ne C o ns u mer Healt hcare C o nfi de ntial
Te m plate Ver si o n Effecti ve: 2 2-J u n-2 0 1 7
Pa ge 5 7 of  6 2
Tar bet WJ, 
B o o ne M, 
Sc h mi dt N F. Ef fect of  a De nt ure A d hesi ve o n C o m p lete De nt ure 
Di slo d ge me nt D uri n g Mast icati on. J. Pr ost het. De nt. 1 9 8 0; 4 4( 4): 3 7 4 -8.
W o rld Me dical Ass oci at i on. Declarat i on of Helsi n ki, 5 9t h Ge neral Asse m bl y, S e o ul. 2 0 0 8.
1 3
A P P E N DI C E S
1 3. 1
A B B R E VI A TI O N S
T he f o ll owi n g i s a list of a b bre viat i ons t hat m a y be use d i n t he pr ot oc ol.
T a bl e 1 3 - 1
A b br e vi ati o n
A b br e vi ati o n
T er m
° C
D e gr e e C e nti gr a d e
° F
D e gr e e F a hr e n h eit
A E
A d v er s e E v e nt
A N O V A
A n al y si s of V ari a n c e
CI
C o nfi d e n c e I nt er v al
C R F
C a s e R e p ort F or m
C S A
Cli ni c al St u d y A gr e e m e nt
C T A
Cli ni c al Tri al A p pli c ati o n
e C R F
El e ctr o ni c C a s e R e p ort F or m
E u dr a C T
E ur o p e a n Cli ni c al Tri al s D at a b a s e
F D A
F o o d a n d Dr u g A d mi ni str ati o n ( U nit e d St at e s)
F D A A A
F o o d a n d Dr u g A d mi ni str ati o n A m e n d m e nt s A ct ( U nit e d St at e s)
g
Gr a m
G C P
G o o d Cli ni c al Pr a cti c e
G S K
Gl a x o S mit h Kli n e
G S K C H
Gl a x o S mit h Kli n e C o n s u m er H e alt h c ar e
I C H
I nt er n ati o n al C o nf er e n c e o n H ar m o ni s ati o n
I R B
I n stit uti o n al R e vi e w B o ar d
L S L V
L a st S u bj e ct L a st Vi sit 
M e d D R A
M e di c al Di cti o n ar y f or R e g ul at or y A cti viti e s
N/ A
N ot A p pli c a bl e
O S T
Or al S oft Ti s s u e
PI
Pri n ci p al I n v e sti g at or
S A E
S eri o u s A d v er s e E v e nt
S O P
St a n d ar d O p er ati n g Pr o c e d ur e
S S
S af et y St at e m e nt
U S
U nit e d St at e s
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
2 4- O ct- 2 0 1 7 0 8: 4 9: 0 5
 
2 0 8 3 9 7 Cli ni c al Pr ot o c ol 2. d o c x
el d o _ c o ntr oll e d
2. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d b 1 b 9 1
Pa ge 5 7 of 6 2

S o di u m -calci u m mi xe d partial salt of p ol y( met h yl vi n y let her/ maleic aci d) a n d car b o x y met h ylcell ul ose
2 0 8 3 9 7
Fi nal Cli nica l Pr ot oc ol, 2 0 Oct 2 0 1 7
Gla x o S mit h Kli ne C o ns u mer Healt hcare C o nfi de ntial
Te m plate Ver si o n Effecti ve: 2 2-J u n-2 0 1 7
Pa ge 5 8 of  6 2
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
2 4- O ct- 2 0 1 7 0 8: 4 9: 0 5
 
2 0 8 3 9 7 Cli ni c al Pr ot o c ol 2. d o c x
el d o _ c o ntr oll e d
2. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d b 1 b 9 1
Pa ge 5 8 of 6 2

S o di u m -calci u m mi xe d partial salt of p ol y( met h yl vi n y let her/ maleic aci d) a n d car b o x y met h ylcell ul ose
2 0 8 3 9 7
Fi nal Cli nica l Pr ot oc ol, 2 0 Oct 2 0 1 7
Gla x o S mit h Kli ne C o ns u mer Healt hcare C o nfi de ntial
Te m plate Ver si o n Effecti ve: 2 2-J u n-2 0 1 7
Pa ge 5 9 of  6 2
1 3. 2
S u bj e ct C o m pl et e d Q u e sti o n n air e
T he f oll owi n g q uest i ons are a b o ut t he pea n ut c he wi n g y o u ha ve j ust u n derta ke n.  Thi n ki n g 
a b o ut o nl y t he pe a n uts y o u h a ve j ust c he we d please circle o ne a ns wer f or eac h q uest i on.
O nl y a ns wer q uest i ons 2 -4 if y o u ci rcle d “ Yes” f or q uestio n 1 a b o ve.
1 
2 
3 
4 
5 
6 
7 
8 
9
1 0
2 ) O n a s c al e of 1 t o 1 0 h o w w o ul d y o u r at e t h e a m o u nt of p e a n ut p arti cl e s t h at w e nt 
u n d er y o ur d e nt ur e ? ( Pl e a s e cir cl e y o ur a n s w er) 
N o n e
N u m er o u s
1 
2 
3 
4 
5 
6 
7 
8 
9
1 0
3 ) O n a s c al e of 1 t o 1 0 h o w w o ul d y o u r at e t h e irrit ati o n of p e a n ut s u n d er y o ur 
d e nt ur e ? ( Pl e a s e cir cl e y o ur a n s w er) 
N ot at all Irrit ati n g
E xtr e m el y Irrit ati n g
1 
2 
3 
4 
5 
6 
7 
8 
9
1 0
4 ) O n a s c al e of 1 t o 1 0 h o w b ot h er e d w er e y o u b y t h e p e a n ut s t h at w e nt u n d er y o ur 
d e nt ur e ? ( Pl e a s e cir cl e y o ur a n s w er) 
N ot at all B ot h er e d
E xtr e m el y B ot h er e d
1) W er e y o u a w ar e of p e a n ut s u n d er y o ur d e nt ur e ? ( Pl e a s e cir cl e y o ur a n s w er) 
Ye s
N o
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
2 4- O ct- 2 0 1 7 0 8: 4 9: 0 5
 
2 0 8 3 9 7 Cli ni c al Pr ot o c ol 2. d o c x
el d o _ c o ntr oll e d
2. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d b 1 b 9 1
Pa ge 5 9 of 6 2

S o di u m -calci u m mi xe d partial salt of p ol y( met h yl vi n y let her/ maleic aci d) a n d car b o x y met h ylcell ul ose
2 0 8 3 9 7
Fi nal Cli nica l Pr ot oc ol, 2 0 Oct 2 0 1 7
Gla x o S mit h Kli ne C o ns u mer Healt hcare C o nfi de ntial
Te m plate Ver si o n Effecti ve: 2 2-J u n-2 0 1 7
Pa ge 6 0 of  6 2
1 3. 3
Pr o d u ct A p pli c ati o n I n str u cti o n s
Ra n d o misat i on C o de [   ]
F or a p plicat i on per c o n ve nt i onal patter n ….
1.
E xtr u de a n d dis p ose of first 1 -2 i nc hes of pr o d uct fr o m eac h t u be t o e ns ure pr o d uct 
c o nsiste nc y.
2.
Pre -l oa d 2 s yrin ges wi t h 1. 0 0 ± 0. 0 5 g a n d 0. 6 0 ± 0. 0 5 g of de nt ure a d hesi ve f or t he 
ma xillar y  a n d ma n di b ular de nt ure res pecti vel y.  S yri n ges s h o uld be l a belle d   St ore t he 
s yrin ges ca p pe d a n d d o n ot st ore f or l o n ger t ha n 4 h o urs.  S y rin ges will  b e la belle d 
wi t h s u bject or ra n d o misat i on n u m ber a n d ide nt if yi n g te xt f or ma xillar y or ma n di b ular 
a p plicat i on.
3.
Cl ea n a n d dr y de nt ures.
4.
A p pl y pr o d uct via t he pre - wei g he d s yri n ge i n s h ort stri ps as s h o w n i n t he dia gra m, n ot 
t o o cl ose t o t he de nt ure e d ges ( 3 stri ps s h o ul d be a p plie d t o t he u p per de nt ure a n d 2 o n 
t he lo wer de nt ure).  All of t he a d hesi ve i n t he pre -wei g he d s yri n ge s h o ul d be use d.
5.
Ha ve t he s u bject ri nse t heir m o ut h wit h water a n d e x pect orate bef ore i nserti n g t he 
de nt ures.
6.
Ha ve t he s u bject press de nt ures i nt o pla ce fir ml y, a n d bite d o w n f or a fe w sec o n ds t o 
sec ure h ol d.
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
2 4- O ct- 2 0 1 7 0 8: 4 9: 0 5
 
2 0 8 3 9 7 Cli ni c al Pr ot o c ol 2. d o c x
el d o _ c o ntr oll e d
2. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d b 1 b 9 1
Pa ge 6 0 of 6 2

S o di u m -calci u m mi xe d partial salt of p ol y( met h yl vi n y let her/ maleic aci d) a n d car b o x y met h ylcell ul ose
2 0 8 3 9 7
Fi nal Cli nica l Pr ot oc ol, 2 0 Oct 2 0 1 7
Gla x o S mit h Kli ne C o ns u mer Healt hcare C o nfi de ntial
Te m plate Ver si o n Effecti ve: 2 2-J u n-2 0 1 7
Pa ge 6 1 of  6 2
Ra n d o misat i on C o de [   ]
F or a p plicat i on per c o nti n u o us stri ps patter n ….
1.
E xtr u de a n d dis p ose of first 1 -2 i nc hes of pr o d uct fr o m eac h t u be t o e ns ure pr o d uct 
c o nsiste nc y.
2.
Pre -l oa d 2 s yrin g es wit h 1. 0 0 ± 0. 0 5 g a n d 0. 6 0 ± 0. 0 5 g of de nt ure a d hesi ve f or t he 
ma xillar y  a n d ma n di b ular de nt ure res pecti vel y.  St ore t he s yrin ges ca p pe d a n d d o n ot 
st ore f or l o n ger t ha n 4 h o urs.  S y rin ges will  be la belle d wit h t he s u bject or 
ra n d omisat i on n u m ber a n d i de nt if yi n g te xt f or ma xillar y or ma n di b ular a p plicati o n.
3.
Cl ea n a n d dr y de nt ures.
4.
A p pl y pr o d uct via a pre -w ei g he d s y rin ge i n l o n g, c o nti n u o us stri ps as s h o w n i n t he 
di a gra m, n ot t o o close t o t he de nt ure e d ges ( 3 stri ps s h o ul d be a p plie d t o t he u p per 
de nt ure a n d 1 o n t he l o wer de nt ure).  All o f t he a d hesi ve i n t he pre -wei g he d s yri n ge 
s h o uld be use d.
5.
Ha ve t he s u bject ri nse t heir m o ut h wit h water a n d e x pect orate bef ore i nserti n g t he 
de nt ures.
6.
Ha ve t he s u bject press de nt ures i nt o place fir ml y, a n d bite d o w n f or a fe w sec o n ds t o 
sec ure h ol d.
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
2 4- O ct- 2 0 1 7 0 8: 4 9: 0 5
 
2 0 8 3 9 7 Cli ni c al Pr ot o c ol 2. d o c x
el d o _ c o ntr oll e d
2. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d b 1 b 9 1
Pa ge 6 1 of 6 2

S o di u m -calci u m mi xe d partial salt of p ol y( met h yl vi n y let her/ maleic aci d) a n d car b o x y met h ylcell ul ose
2 0 8 3 9 7
Fi nal Cli nica l Pr ot oc ol, 2 0 Oct 2 0 1 7
Gla x o S mit h Kli ne C o ns u mer Healt hcare C o nfi de ntial
Te m plate Ver si o n Effecti ve: 2 2-J u n-2 0 1 7
Pa ge 6 2 of  6 2
Ra n d o misat i on C o de [   ]
F or a p plicat i on of n o a d hesi ve ….
1.
Cl ea n a n d dr y de nt ures.
2.
Ha ve t he s u bject ri nse t heir m o ut h wit h water a n d e x pect orate bef ore i nserti n g t he 
de nt ures.
3.
Ha ve t he s u bject press de nt ures i nt o place fir ml y, a n d bite d o w n f or a fe w sec o n ds t o 
sec ure h ol d.
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
2 4- O ct- 2 0 1 7 0 8: 4 9: 0 5
 
2 0 8 3 9 7 Cli ni c al Pr ot o c ol 2. d o c x
el d o _ c o ntr oll e d
2. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d b 1 b 9 1
Pa ge 6 2 of 6 2

Sodium-calcium mixed partial salt of poly(methylvinylether/maleic acid) and carboxymethylcellulose
208397
Final Clinical Protocol, 20 Oct 2017
GlaxoSmithKline Consumer Healthcare Confidential
Template Version Effective: 22-Jun-2017
Page 48 of 62
the PRO data is entered into the DMS by GSK CH, the PROs will be anonymised as agreed 
and documented prior to study initiation. PROs that are source will be retained by the 
investigator and certified copies will be sent to GSK CH. 
In order to protect the privacy of subjects, no Personally Identifiable Information (PII) 
(including the subject's name or initials or birth date) is to be recorded on all PRO’s that will 
be forwarded to GSK CH.
All PRO source data should be reviewed by the study staff/study monitor (as appropriate) to 
ensure that any potential AEs reported on these documents are represented in the DMS.
9.5
External Data 
External Data are subject data obtained externally to the CRF. These data are generated from 
laboratory instruments, computers or other sources and then transcribed into a file and format 
agreed upon by GSK CH to identify the subject and time point referenced in the CRF and/or 
protocol. 
An agreed upon quality control process is performed against the transcribed data to the source 
to ensure the accuracy of the transcription. The transcribed data is transmitted in an agreed 
upon format to GSK CH. 
Reconciliation will be performed between the transcribed data and the clinical database to 
ensure subject and time point referenced in the Clinical Database match before Clinical 
Database Freeze (locking of the database) can occur.
10
STATISTICAL CONSIDERATIONS AND DATA ANALYSES
10.1
Sample Size Determination
Since this is an exploratory methodology development study, no formal sample size 
calculation was conducted.
 
 
 
 
Therefore, approximately 48 (maximum 50) healthy subjects with both maxillary and 
mandibular full dentures will be enrolled in this study.  Subject recruitment will be controlled 
to ensure 50±10% of the subjects will be in each of the low and high Kapur-Olshan groups 
[the low Kapur-Olshan group is defined as a composite Kapur-Olshan score of 6-14 
(clinically fair and good dentures) and the high Kapur-Olshan score as 15-18 (clinically very 
good dentures)].
10.2
Statistical Methods and Analytical Plan
Additional details of the proposed statistical analysis will be documented in the statistical 
analysis plan (SAP), which will be written following finalisation of the protocol and prior to 
study unblinding / analysis (as appropriate).
Page 48 of 62
Document Name 
 
Type 
Version
Document Identifier 
Effective Date 
 
 
 
 
Reason For Issue 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
24-Oct-2017 08:49:05
208397 Clinical Protocol 2.docx
eldo_controlled
2.0; Most-Recent; Effective; CURRENT
Auto Issue
090032d580db1b91
CCI