Stat1200 Protocol 29dec2014

7/23/2019 Stat1200 Protocol 29dec2014

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STAT1200

VERSION:29DEC2014

STUDY PROTOCOL

The Efficacy of the Statinzyme Study Product

on Muscle Aches and Discomfort

An open-label, adaptive-design, remote study

Protocol code: STAT1200

Date of protocol: December 29 2014

IND!: Not Appl"cable

Cl"#"cal p$a%e: II

I#&e%t"'at"o#al prod(ct: Stat"#)*me St(d* Prod(ct

Spo#%or:

Pre%cr"pt"o# V"tam"#% ++C

CRO:,ed"c(% Re%earc$ ++C

2-.20 Road%"de Dr"&e S("te /10

A'o(ra "ll% CA 91/01

T$e "#format"o# "# t$"% doc(me#t "% co#f"de#t"al a#d pro&"ded to *o( a% "#&e%t"'ator or co#%(lta#t

for re&"e b* *o( *o(r %taff a#d appl"cable "#%t"t(t"o#al et$"c% comm"ttee% 3* accept"#' t$"%

doc(me#t *o( a'ree t$at t$e "#format"o# co#ta"#ed $ere"# "ll #ot be d"%clo%ed to ot$er% "t$o(t

a(t$or")at"o# of ,ed"c(% Re%earc$ or Pre%cr"pt"o# V"tam"#% ++C.

STAT1200 PROTOCO+Co#f"de#t"al I#ter#al Doc(me#t 5 ,ed"c(% Re%earc$ ++C

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LST O! A""RE#ATO$S A$D DE!$TO$ O! TERMS

TEM DE!$TO$

8 REATER TAN

+ESS TAN

; APPRORE

3P, 3EATS PER ,IN>TE

?C CENTIRADE @CE+SI>S

CBR CODE OB BEDERA+ RE>+ATIONS

CS C+INICA++= SINIBICANT

CRB CASE REPORT BOR,D3P DIASTO+IC 3+OOD PRESS>RE

E ERIN PRACTICES

t EIT

IPAA EA+T INS>RANCE PORTA3I+IT= AND ACCO>NTA3I+IT=ACT

IV >,AN I,,>NODEBICIENC= VIR>S

R EART RATE

(pA >PERINE A

"e ID EST @TAT IS

I3 INVESTIATOR 3ROC>RE

I3S IRRITA3+E 3OE+ S=NDRO,E

ICD INBOR,ED CONSENT DOC>,ENT

IC INTERNATIONA+ CONBERENCE ON AR,ONIATION

ID IDENTIBICATION N>,3ER

IEC INDEPENDENT ETICS CO,,ITTEE

IR3EC INSTIT>TIONA+ REVIE 3OARDETICS CO,,ITTEE

I>D INTRA >TERINE DEVICE

,edDRA ,EDICA+ DICTIONAR= BOR RE>+ATOR= ACTIVITIES

,' ,I++IRA, @S

,"# ,IN>TE@S,INI,>,

mm' ,I++I,ETER =DRAR=R>, ,ERC>R= @,EAS>RE,ENT OB 3+OOD

PRESS>RE

# N>,3ER BREF>ENC=


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NCI@C NATIONA+ CANCER INSTIT>TE @CRITERIA

NI NATIONA+ INSTIT>TESOB EA+T

NSAID% NON6STEROIDA+ ANTI6INB+A,,ATOR= DR>S

PE P=SICA+ ES ADVERSE EVENT

SAR SERIO>S ADVERSE REACTION

S3P S=STO+IC 3+OOD PRESS>RE

SOP STANDARD OPERATIN PROCED>RE

S>SAR S>SPECTED >NES ADVERSE REACTION

T TI,E>NG >NGNON

VIN VINPOCETINE

VS VITA+ SINS

O OR+D EA+T ORANIATION

t EIT

< TI,ES


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Table of Contents

STUDY%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%&

1. PROTOCOL SUMMARY%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%'

2. $TRODUCTO$%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%&(3. $O$)RE*UREME$T O! $D%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%&&

4. DESCRPTO$ A$D RATO$ALE%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%&+41 ST>D= P>RPOSE12

42 >IDE+INES BOR TE DEVE+OP,ENT OB TE ST>D= PROTOCO+12

5. STUDY O",ECT#ES A$D E$DPO$TS%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%&-71 PRI,AR= O3HECTIVE1/

711 PRI,AR= ENDPOINTS:1/

72 SECONDAR= O3HECTIVE1/721 SECONDAR= ENDPOINTS:1/

6. SAMPLE S.E%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%&/

7. STUDY DES0$%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%&1

.1 A RANDO,IED DO>3+E63+IND P+ACE3O6CONTRO++ED RE,OTE ADAPTIVE6DESIN ST>D= 17

.2 ST>D= CENTERS17

8. $CLUSO$ 2 E3CLUSO$ CRTERA%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%&4-1 INC+>SION CRITERIA1

-2 ESION CRITERIA1

9. SA!ETY A$D TOLERA"LTY%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%&'91 SABET= AND TO+ERA3I+IT= I++ 3E ASSESSED 3= REVIEIN ADVERSE

EVENT REPORTS1.

92 ADVERSE EVENTS1.

10.........................................................................................#STS A$D SC5EDULE

&6101 ST>D= START AND TREAT,ENT1-

1011 V1 J ON+INE SCREEN1-

1012 V17 J PONE SCREEN1-

101/ R>N6IN PERIOD1-1014 ENRO+,ENTSIP,ENTST>D= PROD>CT CONS>,PTION:1-

1017 V2 J @EEG 019

101 V/ J @EEG 419

101. V4 J @EEG - J END OB ST>D=20

11..................................................................$#EST0ATO$AL STUDY PRODUCT

+&111 PROD>CT IDENTIT= DOSIN21

1111 STATIN=,E ST>D= PROD>CT21

112 STORAE 2211/ PACGAIN AND DISPENSIN22

114 +A3E++IN2/

117 ACCO>NTA3I+IT= 24

11 DISPENSIN24

11. CONCO,ITANT ,EDICATION2711.1 PROI3ITED ,EDICATIONS AND INTERVENTIONS27

12....................................................DATA A$ALYSS A$D STATSTCAL MET5ODS

+4


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121 ENRO++,ENT2

122 DATA ,ANAE,ENT2

12/ EN3+INDIN 2

127 DESCRIPTIVE S>,,ARIATION2.12 CO,P+IANCE CA+C>+ATION2.

12. STATISTICA+ =POTESES2.12- STATISTICA+ ANA+=SIS 2.

129 CONTRO+ OB INBERENCE ERRORS2-

1210 ANA+=TICA+ POP>+ATIONS2-

1211 BINA+ REPORT AND BINA+ RESEARC C+OSEO>T 3INDER29

13.................................................................................................ADM$STRATO$

-(1/1 DOC>,ENTATION RECORD ACCESS AND ARCIVIN/0

1/2 DATA PROTECTION/0

1// ESSENTIA+ DOC>,ENTS/0

1/4 CASE REPORT BOR,S @CRBS DIARIES/0

1/7 ARCIVIN/1

14.........................................................................

ADM$STRAT#E PROCEDURES

-+141 A,END,ENTS TO TE PROTOCO+/2

142 DISC+OS>RE OB A++ INBOR,ATION AND RES>+TS/2

14/ P>3+ICATION/2

15............................................................................PROTOCOL MPLEME$TATO$

--171 PROTOCO+ ,ODIBICATIONS//172 PROTOCO+ DEVIATIONS//

17/ F>A+IT= ASS>RANCE AND F>A+IT= CONTRO+//

174 ,ONITORIN//

16.......................................................................................................!$AL REPORT-/

17...........................................................AD#ERSE E#E$TS A$D SA!ETY ASPECTS

-11.1 DEBINITION OB ADVERSE EVENT/7

1.2 DEBINITION OB SERIO>S ADVERSE EVENT/7

1./ DETER,INATION OB TE +IGE+IOOD OB CA>SA+IT=/

1.4 ,ONITORIN OB ADVERSE EVENTS/.

1.7 REPORTIN REF>IRE,ENTS/.

18........................................................................PREMATURE DSCO$T$UATO$

-7

19..................................................................................RE0ULATORY A$D ET5CS

/(191 ETICA+ COND>CT OB TE ST>D=40

192 INSTIT>TIONA+ REVIE 3OARD @IR340

19/ S>3HECT INBOR,ED CONSENT40

194 REF>IRE,ENTS 3= TE INVESTIATOR@S AND TE ST>D= CENTER41

APPENDI< 1: STANBORD E


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APPENDI< 2: VAS PAIN AND SORENESS SCA+E44

APPENDI< /: ,O3I+E APP+ICATIONS47

APPENDI< 4: PO,S 4.

APPENDI< 4: PONE SCREEN49

TA3+E 1: ST>D= B+O CART9

TA3+E 2: ADVERSE EVENTS 1-


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SECO$DARY

O",ECT#E

T$e %eco#dar* obMect"&e "% to a%%e%% t$e eff"cac* of t$e Stat"#)*me St(d*Prod(ct o# "mpro&"#' memor* a#d mood

SECO$DARY

E$DPO$TS C$a#'e "# PO,S (e%t"o##a"re

SAMPLES.E T$e %t(d* "ll e#roll 27 %(bMect%


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TA"LE &9 STUDY !LO: C5ART

Protocol Acti;ity

#&

Online

Screenin)&?

#&%1

Phone

Screenin


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+% $TRODUCTO$


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/% DESCRPTO$ A$D RATO$ALE

4.1 STUDY PURPS!

T$e p(rpo%e of t$"% %t(d* "% to determ"#e t$e effect% of t$e Stat"#)*me St(d* Prod(ct o#

pro&"d"#' rel"ef of m(%cle ac$e% a#d d"%comfort a#d "mpro&"#' memor* a#d mood

4." #U$D!%$&!S 'R T(! D!)!%P*!&T ' T(! STUDY PRT+%

("del"#e% a#d la% t$at $a&e bee# ob%er&ed "# t$"% protocol:Declarat"o# of el%"#L" &er%"o# 199

Note for '("da#ce o# 'ood cl"#"cal pract"ce @IC6CP


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1% STUDY O",ECT#ES A$D E$DPO$TS

.1 PR$*ARY !+T$)!

T$e pr"mar* obMect"&e "% to a%%e%% t$e eff"cac* of t$e Stat"#)*me St(d* Prod(ct o# pro&"d"#'

rel"ef of m(%cle ac$e% a#d d"%comfort

1%&%& Primary End@oints9

C$a#'e "# VAS Pa"# a#d Sore#e%% Scale

C$a#'e "# Sta#ford EKerc"%e 3e$a&"or Scale

C$a#'e "# %elf6reported (e%t"o##a"re @"#cl(d"#' per"p$eral #e(ropat$*

." S!+&DARY !+T$)!

T$e %eco#dar* obMect"&e "% to a%%e%% t$e eff"cac* of t$e Stat"#)*me St(d* Prod(ct o# "mpro&"#'

memor* a#d mood

1%+%& Secondary End@oints9

C$a#'e "# PO,S (e%t"o##a"re


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4% SAMPLE S.E

T$e %t(d* "ll e#roll 27 %(bMect% T$ere "% #o pr"or $(ma# data o# t$"% part"c(lar %t(d* a#de#dpo"#t% to perform a poer calc(lat"o#


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6% $CLUSO$ 2 E3CLUSO$ CRTERA

.1 $&+%US$& +R$T!R$A

ealt$* %(bMect% 1-67 *ear% of a'e

S(bMect% "t$ c$ro#"c m(%cle ac$e% a#d d"%comfort S(bMect% c(rre#tl* o# Stat"#%

H(d'ed b* t$e I#&e%t"'ator to be "# 'e#eral 'ood $ealt$

." !2+%US$& +R$T!R$A

Pre'#a#t a#dor lactat"#' ome#

S(bMect% "t$ a#* l"&er co#d"t"o# "#cl(d"#' $epat"t"% fatt* l"&er l"&er d"%ea%e

>%e of a#* "mm(#o%(ppre%%"&e dr('% "# t$e la%t 12 mo#t$% @"#cl(d"#' %tero"d% or

b"olo'"c%

S(bMect% "t$ a#* $"%tor* of "mm(#e %*%tem d"%order% or a(to6"mm(#e d"%order%

S(bMect $a% a L#o# aller'* to t$e te%t mater"al% act"&e or "#act"&e "#'red"e#t%


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7% SA!ETY A$D TOLERA"LTY

3.1 SA'!TY A&D T%!RA$%$TY $%% ! ASS!SS!D Y R!)$!$ AD)!RS! !)!&TR!PRTS.

3." AD)!RS! !)!&TS

Bre(e#c* a#d "#te#%"t* of AE% a#d %er"o(% AE% "ll be recorded "# deta"l ba%ed o# t$e

%(bMect% "#ter&"e% d(r"#' eac$ &"%"t

To obta"# comparable doc(me#tat"o# o# AE% t$e "#&e%t"'ator "ll a%L t$e %(bMect t$e follo"#'

ope# %ta#dard")ed (e%t"o#% d(r"#' eac$ &"%"t

TA"LE +9 AD#ERSE E#E$TS

a&e *o( co#%(lted a#* t*pe of doctor @,D De#t"%t Pod"atr"%t C$"ropractor etc 'o#e to t$e

emer'e#c* room or eKper"e#ced a#* c$a#'e% "# *o(r $ealt$ %"#ce t$e la%t &"%"tYes&$o+

If *e% plea%e f"ll o(t t$e AD#ERSE E#E$T 5STORY LO0

a&e *o( %tarted taL"#' a#* #e pre%cr"pt"o#% or o&er6t$e6co(#ter med"cat"o#% $erb% or

%(ppleme#t% %"#ce *o(r la%t &"%"tYes&$o+

If *e% plea%e f"ll o(t t$e CO$COMTA$T MEDCATO$ LO0% Medications hich are

ta=en as a result of a ne si


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&&% $#EST0ATO$AL STUDY PRODUCT

11.1 PRDU+T $D!&T$TY 6 DS$

T$"% "#&e%t"'at"o#al prod(ct "% ma#(fact(red (#der d"etar* %(ppleme#t ,P

&&%&%& Statinzyme Study Product

$STRUCTO$9 TaLe to cap%(le% "t$ food t"ce da"l* for t$e f"r%t fo(r eeL% T$e# taLeto cap%(le% "t$ food o#ce a da* for t$e rema"#der of t$e %t(d*

ACT#E $0REDE$TS9 VITA,IN 3 BO+IC ACID VITA,IN 312 VITA,IN D

BIS OI+ @EICOSAPENTAENOIC ACID DOCOSAERA+ VITA,IN E OI+ 3EESARE ATER


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11.4 %A!%%$

Eac$ %t(d* prod(ct co#ta"#er @SPC "ll co#ta"# 2 perforated label% O#e label ad$ered to t$eSPC $"le o#e "ll be detac$ed a#d placed "#to t$e CRB% T$e label% "ll co#ta"#:

St(d* code #(mber

Pat"e#t #(mber

D"rect"o#% of (%e

Stora'e I#%tr(ct"o#%

Date a#d F(a#t"t* D"%pe#%ed

Date a#d F(a#t"t* Ret(r#ed

PRODUCT LA"EL 8 Stat"#)*me St(d* Prod(ct

Study D9 STAT&+(( Pre%cr"pt"o# V"tam"#% ++C

n;esti


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11./ +&+*$TA&T *!D$+AT$&

&&%'%& Prohiited Medications and nter;entions

T$e follo"#' prod(ct% a#d "#ter&e#t"o#% are #ot perm"tted $"le t$e pat"e#t "% o# t$"%

St(d*: A#*Allowed Medications and Interventions

All med"cat"o#% a#d #o#6med"c"#al "#ter&e#t"o#% %$all be recorded d(r"#' t$e e#t"re %t(d*per"od

T$e follo"#' prod(ct% "ll be perm"tted d(r"#' t$e %t(d* a#d m(%t be recorded o# t$e

appropr"ate St(d* Ca%e Report Borm@%:

ormo#al Co#tracept"o# "#cl(d"#' oral patc$ or de&"ce% @e' $ormo#al

r"#'% or I>D%

O# eac$ &"%"t #e co#com"ta#t med"cat"o#% or c$a#'e% of co#com"ta#t med"cat"o#% m(%tbe doc(me#ted T$"% "ll be recorded b* t$e &"rt(al cl"#"c %t(d* %taff e&er* &"%"t


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&+% DATA A$ALYSS A$D STATSTCAL MET5ODS

1".1 !&R%%*!&T

S(bMect% meet"#' all of t$e "#cl(%"o# cr"ter"a a#d #o#e of t$e eKcl(%"o# cr"ter"a "ll be e#rolled "#

t$e %t(d*

After t$e %(bMect $a% completed t$e o#l"#e %cree#"#' &"%"t @V1 a#d t$e telep$o#e %cree#"#' &"%"t

@V17 a#d $a% met all of t$e "#cl(%"o# cr"ter"a a#d #o#e of t$e eKcl(%"o# cr"ter"a t$e %(bMect "ll

be a%%"'#ed t$e #eKt a&a"lable e#rollme#t ID

1"." DATA *A&A#!*!&T

T$e mo#"tor"#' team "ll e#%(re t$at t$e %(bMect% are compl"a#t Parallel d(al data reco#%tr(ct"o#

a#d tra#%format"o# "ll be do#e b* data ma#a'eme#t per%o##el acro%% all e#dpo"#t% Data

&al"dat"o# a#d reco#c"l"at"o# of parallel tra#%format"o# "ll occ(r after t$e d(al datatra#%format"o# proce%% Data f"le% "ll be pa%%ord6protected b* t$e data ma#a'eme#t team for

data "#te'r"t* a#d co#f"de#t"al"t* p(rpo%e% pr"or to a#* a#al*%e% made b* t$e 3"o%tat"%t"c"a#%

1".7 !2A*$&AT$& ' DATA

All data eleme#t% "ll be %cree#ed for rea%o#able#e%% a#d all m"%%"#' %(%p"c"o(% or "mpo%%"ble

&al(e% "ll be referred bacL to t$e mo#"tor"#' team for (er* 'e#erat"o# a#d re%ol(t"o# All

#(mer"cal &ar"able% "ll be te%ted for #ormal"t* a#d data fo(#d to be %(b%ta#t"all* #o#6#ormall*d"%tr"b(ted "ll be a#al*)ed b* appropr"ate #o#6parametr"c met$od%

1".4 DATA %+8 A&D U&%$&D$

After all %(%p"c"o(% e#tr"e% "# t$e databa%e $a&e bee# re%ol&edU a data locL form "ll be %"'#ed b*t$e ead of Sc"e#t"f"c Data ,a#a'eme#t a#d A#al*%"% team to formall* locL t$e databa%e

+ocLed databa%e "ll be free from a#* c$a#'e% o# t$e data %o(rce% a#d data e#tr"e% Data (#locL

form %$o(ld be "%%(ed a#d %"'#ed "f t$ere "ll be c$a#'e% #eeded to reflect or "#te'rate o# t$edataba%e


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1". D!S+R$PT$)! SU**AR$0AT$&

All &ar"able% (#der "#&e%t"'at"o# "ll be %(mmar")ed b* t"me po"#t E#dpo"#t% "# "#ter&alrat"o%cale "ll be pre%e#ted a% @# mea# %ta#dard de&"at"o# a#d %ta#dard error N(mer"cal &ar"able%

"ll al%o be pre%e#ted 'rap$"call* a% plot% of a&era'e &al(e &er%(% t"me

Bor eac$ e#dpo"#t "# at lea%t ord"#al %cale t$e d"ffere#ce% betee# t"me per"od% for eac$ prod(ct

'ro(p "ll be te%ted for #om"#al %"'#"f"ca#ce (%"#' #o#6parametr"c te%t @"lcoKo# S"'#ed Ra#L

Te%t or S"'# Te%t D"ffere#ce "# t$e d"%tr"b(t"o# betee# arm% "ll be te%ted (%"#' #o#6parametr"c C$"6%(are Te%t

Bor t$o%e #(mer"cal e#dpo"#t% t$at ere fo(#d to $a&e #ormall* d"%tr"b(ted data compar"%o#

betee# prod(ct% "ll be a%%e%%ed (%"#' I#depe#de#t t6te%t for 'ro(p d"ffere#ce% at eac$ t"me

po"#t a#d pa"red %ample t6te%t "ll be (%ed to a%%e%% "t$"#6'ro(p c$a#'e% from ba%el"#e to eac$

%(b%e(e#t t"me po"#t% Bor #o#6#ormall* d"%tr"b(ted #(mer"cal e#dpo"#t% "lcoKo# ,a##6$"t#e* te%t for compar"%o# betee# prod(ct% to a%%e% betee# 'ro(p d"ffere#ce% at eac$ t"me

po"#t a#d "lcoKo# S"'#ed Ra#L% te%t or S"'# te%t "ll be (%ed to a%%e%% "t$"#6'ro(p c$a#'e%from ba%el"#e to eac$ %(b%e(e#t t"me po"#t%

All te%t% of $*pot$e%e% "ll be do#e at alp$a007

1".9 +*P%$A&+! +A%+U%AT$&

Compl"a#ce "ll be calc(lated a% follo%:

Compl"a#ce @N(mber of %t(d* prod(ct co#%(medN(mber of da*% %"#ce la%t &"%"t K 100

Compl"a#ce "ll be adM(%ted "f do%e t"trat"o# "% (%ed

1"./ STAT$ST$+A% (YPT(!S!S

T$e #(ll $*pot$e%e% te%ted for t$"% %t(d* are t$e follo"#':

T$ere ere #o %"'#"f"ca#t c$a#'e% "# t$e VAS Pa"# a#d Sore#e%% Scale Sta#ford EKerc"%e

3e$a&"or Scale a#d Self6Reported (e%t"o##a"re from 3a%el"#e to ot$er t"me po"#t%

T$ere ere #o %"'#"f"ca#t c$a#'e% "# t$e PO,S (e%t"o##a"re from 3a%el"#e to ot$er

t"me po"#t%

1". STAT$ST$+A% A&A%YS$S

Stat"%t"cal Softare for Soc"al Sc"e#ce% @SPSS &er%"o# 19 "ll be (%ed to r(# all de%cr"pt"&e a#d"#fere#t"al a#al*%e% for all e#dpo"#t%

Efficacy Analysis


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$ole %t(d* d(rat"o# It "'#ore% #o#6compl"a#ce protocol de&"at"o#% "t$draal a#d a#*t$"#'

t$at $appe#% after ra#dom")at"o#

1".11'$&A% R!PRT A&D '$&A% R!S!AR+( +%S!UT $&D!R

After data a#al*%"% f"#al cl"#"cal %t(d* report "ll be pro&"ded b* t$e CRO to t$e %po#%or T$e

CRO "ll %(mmar")e t$e re%(lt% $"c$ acc(ratel* reflect t$e cl"#"cal data of t$"% %t(d*

All e%%e#t"al doc(me#t% $"c$ "#cl(de% CRB% %t(d* mater"al% ad&er%e e&e#t pa'e% for eac$

%(bMect protocol de&"at"o#% databa%e a#d t$e B"#al report "ll be e#clo%ed "# a B"#al Re%earc$

Clo%eo(t b"#der T$e b"#der %er&e% a% a repo%"tor* of t$e o&erall %t(d* proce%%


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VERSION:29DEC2014

17. AR+($)$

T$e "#&e%t"'ator m(%t arc$"&e all e%%e#t"al doc(me#t% of t$"% cl"#"cal %t(d* "#cl(d"#' CRB% for a

m"#"m(m per"od of 7 *ear% after re'(lar %t(d* e#d or after premat(re d"%co#t"#(at"o# of t$e

%t(d* @"f appl"cable "# accorda#ce "t$ IC


6 Pa'e /2 of 716


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STAT1200

VERSION:29DEC2014

&/% ADM$STRAT#E PROCEDURES

14.1 A*!&D*!&TS T T(! PRT+%

S$o(ld a#* rele&a#t c$a#'e be re("red to t$e %"'#ed f"#al protocol a protocol ame#dme#t "ll

be re("red Rele&a#t c$a#'e "% def"#ed a% a#* co#%"%te#t c$a#'e t$at de&"ate% from t$eproced(re% a% o(tl"#ed "# t$e protocol "ll re("re a# ame#dme#tT$"% dec"%"o# "% made b* t$e

"#&e%t"'ator T$e ame#dme#t m(%t be %"'#ed b* t$e pr"#c"pal "#&e%t"'ator t$e proMect ma#a'er%of t$e %po#%or a#d t$e CRO a#d "f #ece%%ar* b* t$e %tat"%t"c"a# If t$o%e ame#dme#t% are

%(b%ta#t"al a#d are l"Lel* to $a&e a# "mpact o# t$e %afet* of t$e tr"al %(bMect% or t$e* c$a#'e t$e

"#terpretat"o# of t$e %c"e#t"f"c doc(me#t% "# %(pport of t$e co#d(ct of t$e tr"al or "f t$e* are

ot$er"%e %"'#"f"ca#t t$e %po#%or "ll #ot"f* Et$"c% Comm"ttee% @IR3IEC co#cer#ed T$e PIm(%t %(bm"t a# ame#dme#t re(e%t to t$e IR3 a#d rece"&e r"tte# appro&al pr"or to

"mpleme#tat"o# of a#* c$a#'e to t$e protocol

14." D$S+%SUR! ' A%% $&'R*AT$& A&D R!SU%TS

All "#format"o# co#cer#"#' t$e re%(lt% der"&ed from t$e %t(d* a#d t$e "#&e%t"'at"o#al prod(ct are

re'arded a% co#f"de#t"al Pr"or to p(bl"cat"o# of t$e %t(d* re%(lt% t$e "#&e%t"'ator% a#d member%

of t$e"r re%earc$ team% are #ot perm"tted to d"%clo%e a#* %(c$ "#format"o# 3* $"% %"'#at(re t$e"#&e%t"'ator@% a'ree@% to Leep t$e data co#f"de#t"al

14.7 PU%$+AT$&

After data a#al*%"% t$e CRO "ll %(mmar")e t$e re%(lt% "# a f"#al report $"c$ acc(ratel* reflect%t$e cl"#"cal data of t$"% %t(d*

If p(bl"cat"o# "% dec"ded "# t$e f(t(re a d"%c(%%"o# "ll be $eld "t$ t$e %po#%or to determ"#e t$e

appropr"ate med"(m A#* p(bl"cat"o# of t$e tr"al data "ll be $oll* co#%"%te#t "t$ t$e"#te'rated f"#al report "# accorda#ce "t$ t$e et$"cal pr"#c"ple% of t$e Declarat"o# of el%"#L"


6 Pa'e // of 716


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STAT1200

VERSION:29DEC2014

&1% PROTOCOL MPLEME$TATO$

T$"% protocol a% de&eloped accord"#' to IC6CP '("del"#e% @CP,PIC1/797 a#d to t$e%ta#dard% of t$e CRO% SOP%

1.1 PRT+% *D$'$+AT$&S

I# t$e e&e#t t$at a mod"f"cat"o# of t$e protocol become% #ece%%ar* d(e to %afet* %(bMect accr(al

or ot$er co#%"derat"o#% t$e c$a#'e% "ll be re&"eed b* bot$ t$e Spo#%or a#d IR3 a#d $e#

#ece%%ar* re&"eed a#d appro&ed b* t$e BDA No c$a#'e% %$all be "mpleme#ted (#t"l

appropr"ate re&"e a#d appro&al $a% bee# rece"&ed eKcept $e# #ece%%ar* to el"m"#ate a#"mmed"ate $a)ard@% to t$e %t(d* %(bMect%

1." PRT+% D!)$AT$&S

De&"at"o#% to t$e protocol m(%t be doc(me#ted o# t$e appropr"ate CRB a#d reported to t$eSpo#%or T$e cl"#"cal %"te "ll ma"#ta"# doc(me#tat"o# of t$e date% a#d rea%o#% for eac$

de&"at"o# from t$e protocol "# compl"a#ce "t$ 21 Code of Bederal Re'(lat"o#% @CBR /120

De&"at"o#% m(%t be reported to t$e IR3 at clo%eo(t or at co#t"#("#' re&"e

1.7


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STAT1200

VERSION:29DEC2014

&4% !$AL REPORT

A f"#al cl"#"cal %t(d* report "ll be pro&"ded b* t$e CRO to t$e %po#%or A f"#al report m(%t be%(bm"tted to t$e IR3 to clo%e o(t t$e %t(d*


6 Pa'e /7 of 716


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37/51

STAT1200

VERSION:29DEC2014

a Re%(lt% "# deat$

b I% l"fe6t$reate#"#' @refer% to a# e&e#t "# $"c$ t$e pat"e#t a% at r"%L of deat$ at t$e t"me

of t$e e&e#t It doe% #ot refer to a# e&e#t $"c$ $*pot$et"call* m"'$t $a&e ca(%ed deat$ "f"t ere more %e&ere

c Re("re% $o%p"tal")at"o# or prolo#'at"o# of eK"%t"#' $o%p"tal")at"o#

d Re("re% %"'#"f"ca#t "#ter&e#t"o# to pre&e#t a %er"o(% o(tcome o(t%"de of a $o%p"tal%ett"#' @e' "#te#%"&e treatme#t "# a# emer'e#c* room or at $ome for aller'"c

bro#c$o%pa%mU blood d*%cra%"a% or co#&(l%"o#% t$at do #ot re%(lt "# $o%p"tal")at"o#

e Re%(lt% "# per%"%te#t or %"'#"f"ca#t d"%ab"l"t*"#capac"t* of t$e %t(d* a#d m(%t be folloed

(#t"l re%ol(t"o# @e' deat$ re%ol&ed %table "t$ or "t$o(t "#ter&e#t"o#

1/.7 D!T!R*$&AT$& ' T(! %$8!%$(D ' +AUSA%$TY

$e# a%%e%%"#' t$e l"Lel"$ood t$at a# ad&er%e e&e#t "% ca(%all* related to a# "#&e%t"'at"o#al

prod(ct or protocol t$e follo"#' parameter% "ll be co#%"dered:

a Temporal relat"o#%$"p betee# t$e "#&e%t"'at"o#al prod(ctprotocol a#d t$e ad&er%ee&e#tU

b 3"olo'"c pla(%"b"l"t* of relat"o#%$"pU

c Pat"e#t% (#derl*"#' cl"#"cal %tate or co#com"ta#t a'e#t%t$erap"e%Ud $ere appl"cable doe% t$e e&e#t abate o# d"%co#t"#(at"o# of t$e "#&e%t"'at"o#al

prod(ct @i.e.,dec$alle#'eU

e $ere appl"cable doe% t$e e&e#t reappear o# repeat eKpo%(re to t$e "#&e%t"'at"o#al

prod(ct @i.e.,rec$alle#'e

T$e follo"#' def"#"t"o#% "ll be (%ed to a%%e%% related#e%% of a# ad&er%e e&e#t:

GDefiniteH A react"o# t$at follo% a pla(%"ble temporal %e(e#ce from adm"#"%trat"o#of t$e prod(ct a#d follo% a L#o# re%po#%e patter# to t$e %(%pected prod(ct

a#d ca# be co#f"rmed "t$ a po%"t"&e re6c$alle#'e te%t or %(pport"#'

laborator* data

GProaleH A react"o# t$at follo% a pla(%"ble temporal %e(e#ce from adm"#"%trat"o# of

t$e prod(ct a#d follo% a L#o# re%po#%e patter# T$e AE ca##ot berea%o#abl* eKpla"#ed b* t$e L#o# c$aracter"%t"c% of t$e pat"e#t% cl"#"cal

%tate

GPossileH A react"o# t$at follo% a pla(%"ble temporal %e(e#ce from adm"#"%trat"o# of

t$e prod(ct a#d follo% a L#o# re%po#%e patter# T$e AE ma* al%o $a&ebee# prod(ced b* t$e pat"e#t% cl"#"cal %tate

GRemoteH T$e c(rre#t %tate of L#oled'e "#d"cate% t$at a relat"o#%$"p "% (#l"Lel*


6 Pa'e /. of 716


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STAT1200

VERSION:29DEC2014

G$oneH No relat"o#%$"p betee# t$e eKper"e#ce a#d t$e adm"#"%trat"o# of %t(d*

prod(ctU AE "% related to ot$er et"olo'"e% %(c$ a% co#com"ta#t med"cat"o#% or

pat"e#t% cl"#"cal %tate @"e d(e to "#terc(rre#t pote#t"al "ll#e%% @e%

1/.4 *&$TR$ ' AD)!RS! !)!&TS

S(bMect% "ll be "#ter&"eed "# a #o#6lead"#' a* at e&er* %t(d* &"%"t to "de#t"f* pote#t"al

ad&er%e e&e#t% T$e %ta#dard "#("r* "% Qa&e t$ere bee# a#* c$a#'e% "# *o(r $ealt$ %"#ce *o(r

la%t &"%"t T$e occ(rre#ce of a# ad&er%e e&e#t "ll be ba%ed o# t$e c$a#'e% "# t$e %(bMect%p$*%"cal eKam"#at"o# laborator* re%(lt% a#dor %"'#% a#d %*mptom% Ad&er%e e&e#t% "ll be

recorded t$ro('$o(t adm"#"%trat"o# of t$e "#&e%t"'at"o#al prod(ct a#d follo"#' ce%%at"o# of t$e

te%t prod(ct "# a ca%e report form @CRB ToK"c"t* a#d ad&er%e e&e#t% "ll be a%%e%%ed (%"#' t$eONCIC @adapted ToK"c"t* Scale

$e#e&er fea%"ble %"'#% a#d %*mptom% "#d"cat"#' a commo# (#derl*"#' pat$olo'* %$o(ld be#oted a% o#e compre$e#%"&e e&e#t AE% of a %(%pected probable m"%%"#' or (#L#o# ca(%al"t*

"ll be a%%e%%ed a% treatme#t6related ad&er%e dr(' react"o# I#d"&"d(al AE% "ll be %cored a#d'rade per ToK"c"t* Scale 3(t "# add"t"o# to t$"% t$e St(d* P$*%"c"a# %$o(ld al%o r"te a br"ef#arrat"&e t$at a%%e%%e% t$e AE

1/. R!PRT$ R!SAE? Re@ortinone number, ?a@, email, et=.


6 Pa'e /- of 716


39/51

STAT1200

VERSION:29DEC2014

Ide#t"f"cat"o# of t$e %t(d*:

Study =ode or title, respe=tively, investigational produ=t:s;

Ide#t"f"cat"o# of t$e pat"e#t:

Assigned 7-digit patient number, se@ and date o? birt>.

De%cr"pt"o# of t$e Ser"o(% Ad&er%e E&e#t%er"o(% ad&er%e react"o#:

Symptoms6diagnosis, t>erapeuti= measures taen, out=ome as ?ar as already noBn,

=ausal relations>ip

T$"% "#format"o# ca# be tra#%m"tted &"a telep$o#e faK or ema"l I# t$e ca%e of a p$o#e reportt$"% prel"m"#ar* report "ll be r"tte# b* t$e CRO accord"#' to t$e "#format"o# '"&e# a#d %"'#ed

b* t$e CRO

T$e "#&e%t"'ator %$o(ld pro&"de a f"#al report "t$"# a rea%o#able t"me after t$e "#"t"al report

depe#d"#' o# t$e d(rat"o# of t$e e&e#t a#d a&a"lab"l"t* of e&al(at"o#% a#d report% of t$"rd part"e%T$e "#&e%t"'ator m(%t forard t$e SAE report form b* faK to t$e CRO or t$e %po#%or $o "ll

"#form eac$ ot$er T$e or"'"#al of t$e SAE report form "ll t$e# be collected b* t$e CRO a#d

%e#t to t$e %po#%or T$e "#&e%t"'ator %$o(ld report t$e SAE to t$e IR3 "t$"# 10 da*% of

d"%co&er*

I# t$e e&e#t of t$e deat$ of a tr"al %(bMect t$e "#&e%t"'ator %$all %(ppl* t$e %po#%or a#d t$e Et$"c%

Comm"ttee "t$ a#* add"t"o#al "#format"o# re(e%ted Per%o#al data m(%t be p%e(do#*m"%ed

pr"or to be"#' comm(#"cated b* (%"#' t$e %cree#"#' #(mber of t$e tr"al %(bMect


6 Pa'e /9 of 716


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STAT1200

VERSION:29DEC2014

&6% PREMATURE DSCO$T$UATO$

Premat(re d"%co#t"#(at"o#% are def"#ed a% %(bMect% $o do #ot complete t$e %t(d* a% re("red b*t$e %t(d* protocol e"t$er at t$e"r o# re(e%t or at t$e re(e%t of t$e "#&e%t"'ator

T$e %(bMect "% e#t"tled to term"#ate t$e %t(d* at a#* t"me "t$o(t '"&"#' a#* rea%o#% a#d "t$o(t

$a&"#' to eKpect a#* d"%ad&a#ta'e% oe&er t$e "#&e%t"'ator %$o(ld tr* to f"#d o(t a#d doc(me#t

t$e rea%o#% for a premat(re d"%co#t"#(at"o# T$e "#&e%t"'ator ca# %top t$e part"c"pat"o# of a %(bMecta% ell or t$e e#t"re %t(d* "# $er$"% %t(d* ce#ter after co#%"derat"o# of t$e be#ef"t r"%L rat"o

S(bMect% "t$ ab#ormal data %et% ma* al%o be e&al(ated d(r"#' "#ter"m a#al*%"% a#d be remo&ed

from t$e %t(d* T$"% "% appropr"ate a% lo#' a% t$e dec"%"o# "% made pr"or to L#o"#' $"c$

ra#dom")at"o# 'ro(p t$e %(bMect "% part of a#d $elp% e#%(re rel"ab"l"t* of t$e data %et T$e %tat"%t"calteam re%er&e% t$e r"'$t to remo&e o(tl"er data from t$e a#al*%"% before (#6bl"#d"#' $"c$ "% ba%ed

o# t$e d"%cret"o# of t$e re%earc$er%

Study Dro@ Out

S(bMect% $o are ra#dom")ed b(t drop o(t pr"or to complet"#' t$e %t(d* "ll be recorded A recordof rea%o#% $* %(bMect% drop o(t of t$e %t(d* "ll be ma"#ta"#ed All data from re'"%tered %(bMect%

$o tooL at lea%t o#e do%e of t$e %t(d* prod(ct% a#d $o %(b%e(e#tl* dropped o(t %$all be

"#cl(ded "# t$e %afet* a#al*%"%

Screenin< !ailures

Scree#"#' fa"l(re% are def"#ed a% t$o%e %(bMect% $o appeared at &"%"t 1 $o co#%e#ted topart"c"pate "# t$e %t(d* b* %"'#"#' %t(d* %pec"f"c "#formed co#%e#t doc(me#t% a#d $o ot$er"%e

ere deemed "#el"'"ble to part"c"pate "# t$"% %t(d* A record of %cree#ed %(bMect% a#d rea%o#% for

"#el"'"b"l"t* "ll be ma"#ta"#ed

Patient Termination or :ithdraal

I# t$e e&e#t of %t(d* d"%co#t"#(at"o# t$e follo"#' data "ll be recorded: Date of t$e late%t treatme#t (#der t$e %t(d*

Date a#d t"me of t$e late%t co#tact betee# "#&e%t"'ator a#d pat"e#t

Rea%o# for dec"%"o# to d"%co#t"#(e


6 Pa'e 40 of 716


41/51

STAT1200

VERSION:29DEC2014

&7% RE0ULATORY A$D ET5CS

13.1 !T($+A% +&DU+T ' T(! STUDY

T$e ("del"#e% of t$e orld ,ed"cal A%%oc"at"o#% Declarat"o# of el%"#L" "# "t% re&"%ed ed"t"o#

of 1991

a#d t$e ("del"#e% of ood Cl"#"cal Pract"ce @CP,PIC1/797 "ll be ad$ered to2

13." $&ST$TUT$&A% R!)$! ARD :$R;

Pr"or to t$e "#"t"at"o# of t$e %t(d* t$"% protocol "#cl(d"#' t$e I#formed Co#%e#t Borm "ll be%(bm"tted to t$e "#depe#de#t IR3 a#d t$e tr"al "ll #ot %tart (#t"l (#co#d"t"o#al appro&al "%

rece"&ed

13.7 SU!+T $&'R*!D +&S!&T

T$e "#&e%t"'ator"#&e%t"'ator% de%"'#ee m(%t eKpla"# t$e %t(d* f(ll* to t$e %(bMect T$e I#formed

Co#%e#t doc(me#t m(%t be pro&"ded to t$e %(bMect "# paper or "# a# electro#"c form t$at "%

(#der%ta#dable for t$e %(bMect T$e I#formed Co#%e#t m(%t be pre%e#ted to t$e %(bMect bot$&erball* a#d electro#"call* a#d "% "#te#ded to %er&e a% a ba%"% for t$e eKpla#at"o# of t$e %t(d* b*

t$e "#&e%t"'ator T$"% "ll be performed &"a a# electro#"c %"'#at(re o# t$e o#l"#e co#%e#t form

a#d "ll be &erball* &er"f"ed b* t$e %t(d* %taff "t$ %"'#"#' t$e I#formed Co#%e#t doc(me#t t$e%(bMect a'ree% e(all* t$at data collected d(r"#' t$e co(r%e of t$e %t(d* ma* be pa%%ed o# "# a

p%e(do#*mo(% ma##er to t$e appropr"ate a(t$or"t"e% a#d to t$e %po#%or T$e CRO "ll pro&"de

t$e "#&e%t"'ator "t$ a %(ff"c"e#t #(mber of cop"e% of t$e appro&ed %(bMect "#format"o# a#d

I#formed Co#%e#t Borm%

T$e "#formed co#%e#t proce%% "#&ol&e% a# o#l"#e "#fo'rap$"c pre%e#tat"o# deta"l"#' all of t$ecompo#e#t% of t$e %t(d* Bollo"#' t$"% a# electro#"c %"'#at(re "ll be recorded b* t$e %(bMect

co#f"rm"#' t$at t$e* (#der%ta#d t$e %t(d* proced(re% a% deta"led "# t$e o#l"#e co#%e#t doc(me#tI# add"t"o# &erbal co#%e#t "ll be obta"#ed b* t$e &"rt(al cl"#"c team d(r"#' t$e telep$o#e%cree#"#' t$at follo% t$e o#l"#e %cree#

T$e "#&e%t"'ator"#&e%t"'ator% de%"'#ee "ll #ot (#dertaLe a#* %t(d*6related "#&e%t"'at"o#% "t$a#* %pec"f"c %(bMect pr"or to obta"#"#' r"tte# I#formed Co#%e#t

S(bMect% $o ref(%e to %"'# t$e I#formed Co#%e#t or $o do #ot a'ree to record"#' a#d report"#'

t$e"r p%e(do#*mo(% data to re("red a(t$or"t"e% ma* #ot be "#cl(ded "# t$"% %t(d* S(bMect% $o

"t$dra I#formed Co#%e#t ma* #ot co#t"#(e "# t$e %t(d* @d"%co#t"#(at"o#

T$e co#te#t of t$e r"tte# %(bMect "#format"o# a#d I#formed Co#%e#t "ll be "# accorda#ce "t$t$e ("del"#e% of ood Cl"#"cal Pract"ce @CP,PIC1/797 a#d 21 CBR Part 70 S(bpart 3S(ff"c"e#t t"me "ll be alloed to d"%c(%% a#* (e%t"o#% ra"%ed b* t$e %(bMect abo(t t$e "#formed

co#%e#t T$e I#formed co#%e#t form m(%t be electro#"call* %"'#ed a#d dated b* t$e %(bMect a#d

&er"f"ed &erball* b* t$e I#&e%t"'ator% de%"'#ee $o re&"eed t$e I#formed Co#%e#t Doc(me#t"t$ t$e %(bMect d(r"#' t$e remote &"%"t T$e "#&e%t"'ator m(%t reta"# t$e record of t$e

electro#"call* %"'#ed doc(me#t a% part of t$e %t(d* record%


6 Pa'e 41 of 716


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STAT1200

VERSION:29DEC2014

REBERENCE +IST


6 Pa'e 4/ of 716


44/51

APPE$D3 &9 STA$!ORD E3ERCSE "E5A#OR SCALE

STA$!ORD E3ERCSE "E5A#OR SCALEVer%"o# 11

Durin< the @ast ee=B e&e# "f "t a% #ot a t*p"cal eeL for *o( $o m(c$ total t"me @for t$e entire

ee= d"d *o( %pe#d o# eac$ of t$e follo"#' @Plea%e c"rcle one #(mber for eac$ (e%t"o#

Eercise "eha;iors $oneLess than

-(

min2=

-()4(

min2=

&)- hrs

@er ee=

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than -

hrs2=

1 Stretc$"#' or %tre#'t$e#"#' eKerc"%e% @ra#'eof mot"o# (%"#' e"'$t% etc

0 1 2 / 4

2 alL for eKerc"%e 0 1 2 / 4

/ S"mm"#' or a(at"c eKerc"%e 0 1 2 / 4

4 3"c*cl"#' @"#cl(d"#' %tat"o#ar*

eKerc"%e b"Le%0 1 2 / 4

7 Ot$er aerob"c eKerc"%e e("pme#t

@Sta"rma%ter ro"#' %L""#' mac$"#e etc

0 1 2 / 4

Ot$er aerob"c eKerc"%eSpe=i?y\\\\\\\\\\\\\\\\\\\\\\\\\

0 1 2 / 4


45/51

APPE$D3 +9 #AS PA$ A$D SORE$ESS SCALE

A%%"'# a #(mber from 0 @)ero to 10 @te# to *o(r pa"# le&el If *o( $a&e #o pa"# (%e a 0 A% t$e#(mber% 'et $"'$er t$e* %ta#d for pa"# t$at "% 'ett"#' or%e A 10 mea#% t$e pa"# "% a% bad a% "t ca# be


46/51


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POMS IVer%"o# 12

Please ?ill in t>e in?ormation beloBC

A'e: 3"rt$date:@mm6dd6**** 66

e#der: ,ale1

Bemale2Toda*% date:@mm6dd6**** 66

3elo "% a l"%t of ord% t$at de%cr"be feel"#'% t$at people $a&e Plea%e read eac$ ord caref(ll*

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APPE$D3 19 P5O$E SCREE$

SU",ECT $AME

SU",ECT CO$TACT $!ORMATO$

SU",ECTJS !ULL $AME

@

Stat1200 Protocol 29dec2014

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Transcript of Stat1200 Protocol 29dec2014