Clinical trial: NCT02494921
Section: Purpose of Research
Subsections: U Ni V E R Si T Y O F C A Li F O R Ni A, S A N F R A N Ci S C O C O N S E N T T O P A R Ti Ci P A T E I N A R E S E A R C H S T U D Y|U Ni V E R Si T Y O F C A Li F O R Ni A, S A N F R A N Ci S C O C O N S E N T T O P A R Ti Ci P A T E I N A R E S E A R C H S T U D Y|W H Y Is T His St U D Y Bei N G D O Ne ?|W H Y Is T His St U D Y Bei N G D O Ne ?|U Ni V E R Si T Y O F C A Li F O R Ni A, S A N F R A N Ci S C O C O N S E N T T O P A R Ti Ci P A T E I N A R E S E A R C H S T U D Y|U Ni V E R Si T Y O F C A Li F O R Ni A, S A N F R A N Ci S C O C O N S E N T T O P A R Ti Ci P A T E I N A R E S E A R C H S T U D Y|W H Y Is T His St U D Y Bei N G D O Ne ?|W H Y Is T His St U D Y Bei N G D O Ne ?

C C \# 1 4 5 5 1 5: A P h ase 1 b St u d y of t he Or al C D K 4/ 6 I n hi bit or Ri b ocicli b i n C o m bi n ati o n wit h D ocet a xel Pl us Pre d nis o ne i n Met ast atic C astr ati o n- Resist a nt Pr ost ate C a ncer

C C \# 1 4 5 5 1 5: A P h ase 1 b St u d y of t he Or al C D K 4/ 6 I n hi bit or Ri b ocicli b i n C o m bi n ati o n wit h D ocet a xel Pl us Pre d nis o ne i n Met ast atic C astr ati o n- Resist a nt Pr ost ate C a ncer

T he p ur p ose of t his st u d y is t o lear n w het her ri b ocicli b ( L E E 0 1 1), w he n a d de d t o a treat me nt  
( d oceta xel pl us pre d nis o ne) a p pr o ve d f or y o ur t y pe of pr ostate ca ncer, hel ps t o sta bilize or st o p pr o gressi o n of y o ur ca ncer.  
We wa nt t o test t he safet y of ri b ocicli b i n c o m bi nati o n wit h d oceta xel pl us pre d nis o ne at differe nt d ose le vels. We wa nt t o fi n d o ut w hat effects, g o o d a n d/ or ba d, it has o n y o u a n d y o ur t y pe of ca ncer.  
Ri b ocicli b is a dr u g desi g ne d t o bl oc k certai n pr otei ns calle d c ycli n- de pe n de nt pr otei n ki nases t hat are re q uire d f or cells t o di vi de. T hese pr otei ns ma y als o c o ntr ol t he a bilit y of certai n ca ncers t o gr o w.  
Ri b ocicli b is a dr u g t hat has n ot bee n a p pr o ve d b y U. S. F o o d a n d Dr u g A d mi nistrati o n ( F D A) or a n y ot her healt h a ut h orities f or t he treat me nt of pe o ple wit h y o ur me dical c o n diti o n. Ri b ocicli b is c urre ntl y n ot " o n t he mar ket" (a vaila ble f or y o u t o b u y) i n a n y c o u ntr y. As of t he last u p date, ri b ocicli b has bee n a d mi nistere d t o 1 7 9 patie nts as a si n gle a ge nt.  
D oceta xel is a t y pe of c he m ot hera p y t hat bl oc ks cells fr o m di vi di n g. D oceta xel, i n c o m bi nati o n wit h a l o w d ose of a ster oi d calle d pre d nis o ne, has bee n s h o w n t o be a n effecti ve treat me nt f or y o ur t y pe of pr ostate ca ncer a n d has bee n a p pr o ve d b y t he U. S. F o o d a n d Dr u g A d mi nistrati o n.

T he p ur p ose of t his st u d y is t o lear n w het her ri b ocicli b ( L E E 0 1 1), w he n a d de d t o a treat me nt  
( d oceta xel pl us pre d nis o ne) a p pr o ve d f or y o ur t y pe of pr ostate ca ncer, hel ps t o sta bilize or st o p pr o gressi o n of y o ur ca ncer.  
We wa nt t o test t he safet y of ri b ocicli b i n c o m bi nati o n wit h d oceta xel pl us pre d nis o ne at differe nt d ose le vels. We wa nt t o fi n d o ut w hat effects, g o o d a n d/ or ba d, it has o n y o u a n d y o ur t y pe of ca ncer.  
Ri b ocicli b is a dr u g desi g ne d t o bl oc k certai n pr otei ns calle d c ycli n- de pe n de nt pr otei n ki nases t hat are re q uire d f or cells t o di vi de. T hese pr otei ns ma y als o c o ntr ol t he a bilit y of certai n ca ncers t o gr o w.  
Ri b ocicli b is a dr u g t hat has n ot bee n a p pr o ve d b y U. S. F o o d a n d Dr u g A d mi nistrati o n ( F D A) or a n y ot her healt h a ut h orities f or t he treat me nt of pe o ple wit h y o ur me dical c o n diti o n. Ri b ocicli b is c urre ntl y n ot " o n t he mar ket" (a vaila ble f or y o u t o b u y) i n a n y c o u ntr y. As of t he last u p date, ri b ocicli b has bee n a d mi nistere d t o 1 7 9 patie nts as a si n gle a ge nt.  
D oceta xel is a t y pe of c he m ot hera p y t hat bl oc ks cells fr o m di vi di n g. D oceta xel, i n c o m bi nati o n wit h a l o w d ose of a ster oi d calle d pre d nis o ne, has bee n s h o w n t o be a n effecti ve treat me nt f or y o ur t y pe of pr ostate ca ncer a n d has bee n a p pr o ve d b y t he U. S. F o o d a n d Dr u g A d mi nistrati o n.  
  
T his will be t he first ti me t hat all t hree dr u gs, ri b ocicli b, d oceta xel, a n d pre d nis o ne are use d i n c o m bi nati o n t o treat patie nts.  
N o vartis P har mace uticals, I nc. w hic h ma n ufact urers ri b ocicli b is s u p pl yi n g t he st u d y dr u g freeof-c har ge a n d is pr o vi di n g s u p p ort t o t he i n vesti gat or a n d t he i nstit uti o n t o c o n d uct t he st u d y.  
T he Pr ostate Ca ncer F o u n dati o n is als o pr o vi di n g f u n di n g f or t his st u d y.

C C \# 1 4 5 5 1 5: A P h ase 1 b St u d y of t he Or al C D K 4/ 6 I n hi bit or Ri b ocicli b i n C o m bi n ati o n wit h D ocet a xel Pl us Pre d nis o ne i n Met ast atic C astr ati o n- Resist a nt Pr ost ate C a ncer

C C \# 1 4 5 5 1 5: A P h ase 1 b St u d y of t he Or al C D K 4/ 6 I n hi bit or Ri b ocicli b i n C o m bi n ati o n wit h D ocet a xel Pl us Pre d nis o ne i n Met ast atic C astr ati o n- Resist a nt Pr ost ate C a ncer

T he p ur p ose of t his st u d y is t o lear n w het her ri b ocicli b ( L E E 0 1 1), w he n a d de d t o a treat me nt  
( d oceta xel pl us pre d nis o ne) a p pr o ve d f or y o ur t y pe of pr ostate ca ncer, hel ps t o sta bilize or st o p pr o gressi o n of y o ur ca ncer.  
We wa nt t o test t he safet y of ri b ocicli b i n c o m bi nati o n wit h d oceta xel pl us pre d nis o ne at differe nt d ose le vels. We wa nt t o fi n d o ut w hat effects, g o o d a n d/ or ba d, it has o n y o u a n d y o ur t y pe of ca ncer.  
Ri b ocicli b is a dr u g desi g ne d t o bl oc k certai n pr otei ns calle d c ycli n- de pe n de nt pr otei n ki nases t hat are re q uire d f or cells t o di vi de. T hese pr otei ns ma y als o c o ntr ol t he a bilit y of certai n ca ncers t o gr o w.  
Ri b ocicli b is a dr u g t hat has n ot bee n a p pr o ve d b y U. S. F o o d a n d Dr u g A d mi nistrati o n ( F D A) or a n y ot her healt h a ut h orities f or t he treat me nt of pe o ple wit h y o ur me dical c o n diti o n. Ri b ocicli b is c urre ntl y n ot " o n t he mar ket" (a vaila ble f or y o u t o b u y) i n a n y c o u ntr y. As of t he last u p date, ri b ocicli b has bee n a d mi nistere d t o 1 7 9 patie nts as a si n gle a ge nt.  
D oceta xel is a t y pe of c he m ot hera p y t hat bl oc ks cells fr o m di vi di n g. D oceta xel, i n c o m bi nati o n wit h a l o w d ose of a ster oi d calle d pre d nis o ne, has bee n s h o w n t o be a n effecti ve treat me nt f or y o ur t y pe of pr ostate ca ncer a n d has bee n a p pr o ve d b y t he U. S. F o o d a n d Dr u g A d mi nistrati o n.

T he p ur p ose of t his st u d y is t o lear n w het her ri b ocicli b ( L E E 0 1 1), w he n a d de d t o a treat me nt  
( d oceta xel pl us pre d nis o ne) a p pr o ve d f or y o ur t y pe of pr ostate ca ncer, hel ps t o sta bilize or st o p pr o gressi o n of y o ur ca ncer.  
We wa nt t o test t he safet y of ri b ocicli b i n c o m bi nati o n wit h d oceta xel pl us pre d nis o ne at differe nt d ose le vels. We wa nt t o fi n d o ut w hat effects, g o o d a n d/ or ba d, it has o n y o u a n d y o ur t y pe of ca ncer.  
Ri b ocicli b is a dr u g desi g ne d t o bl oc k certai n pr otei ns calle d c ycli n- de pe n de nt pr otei n ki nases t hat are re q uire d f or cells t o di vi de. T hese pr otei ns ma y als o c o ntr ol t he a bilit y of certai n ca ncers t o gr o w.  
Ri b ocicli b is a dr u g t hat has n ot bee n a p pr o ve d b y U. S. F o o d a n d Dr u g A d mi nistrati o n ( F D A) or a n y ot her healt h a ut h orities f or t he treat me nt of pe o ple wit h y o ur me dical c o n diti o n. Ri b ocicli b is c urre ntl y n ot " o n t he mar ket" (a vaila ble f or y o u t o b u y) i n a n y c o u ntr y. As of t he last u p date, ri b ocicli b has bee n a d mi nistere d t o 1 7 9 patie nts as a si n gle a ge nt.  
D oceta xel is a t y pe of c he m ot hera p y t hat bl oc ks cells fr o m di vi di n g. D oceta xel, i n c o m bi nati o n wit h a l o w d ose of a ster oi d calle d pre d nis o ne, has bee n s h o w n t o be a n effecti ve treat me nt f or y o ur t y pe of pr ostate ca ncer a n d has bee n a p pr o ve d b y t he U. S. F o o d a n d Dr u g A d mi nistrati o n.  
  
T his will be t he first ti me t hat all t hree dr u gs, ri b ocicli b, d oceta xel, a n d pre d nis o ne are use d i n c o m bi nati o n t o treat patie nts.  
N o vartis P har mace uticals, I nc. w hic h ma n ufact urers ri b ocicli b is s u p pl yi n g t he st u d y dr u g freeof-c har ge a n d is pr o vi di n g s u p p ort t o t he i n vesti gat or a n d t he i nstit uti o n t o c o n d uct t he st u d y.  
T he Pr ostate Ca ncer F o u n dati o n is als o pr o vi di n g f u n di n g f or t his st u d y.
Clinical trial: NCT02494921
Section: Voluntary Participation
Subsections: C O N S E N T|C O N S E N T|C O N S E N T|C O N S E N T

Y o u ha ve bee n gi ve n c o pies of t his c o nse nt f or m a n d t he E x peri me ntal S u bject's Bill of Ri g hts t o kee p.  
Y o u will be as ke d t o si g n a se parate f or m a ut h orizi n g access, use, creati o n, or discl os ure of healt h i nf or mati o n a b o ut y o u.  
P A R TI CI P A TI O N I N R E S E A R C H I S V O L U N T A R Y. Y o u ha ve t he ri g ht t o decli ne t o partici pate or t o wit h dra w at a n y p oi nt i n t his st u d y wit h o ut pe nalt y or l oss of be nefits t o w hic h y o u are ot her wise e ntitle d.  
If y o u wis h t o partici pate i n t his st u d y, y o u s h o ul d si g n bel o w.  
| Date   | Partici pa nt's Si g nat ure f or C o nse nt                                         |
|--------|--------------------------------------------------------------------------------------|
| Date   | Partici pa nt's Pri nte d Na me                                                      |
| Date   | Pers o n O btai ni n g C o nse nt                                                    |
| Date   | Wit ness - O nl y re q uire d if t he partici pa nt is a n o n- E n glis h s pea ker |

Y o u ha ve bee n gi ve n c o pies of t his c o nse nt f or m a n d t he E x peri me ntal S u bject's Bill of Ri g hts t o kee p.  
Y o u will be as ke d t o si g n a se parate f or m a ut h orizi n g access, use, creati o n, or discl os ure of healt h i nf or mati o n a b o ut y o u.  
P A R TI CI P A TI O N I N R E S E A R C H I S V O L U N T A R Y. Y o u ha ve t he ri g ht t o decli ne t o partici pate or t o wit h dra w at a n y p oi nt i n t his st u d y wit h o ut pe nalt y or l oss of be nefits t o w hic h y o u are ot her wise e ntitle d.  
If y o u wis h t o partici pate i n t his st u d y, y o u s h o ul d si g n bel o w.  
| Date   | Partici pa nt's Si g nat ure f or C o nse nt                                         |
|--------|--------------------------------------------------------------------------------------|
| Date   | Partici pa nt's Pri nte d Na me                                                      |
| Date   | Pers o n O btai ni n g C o nse nt                                                    |
| Date   | Wit ness - O nl y re q uire d if t he partici pa nt is a n o n- E n glis h s pea ker |

Y o u ha ve bee n gi ve n c o pies of t his c o nse nt f or m a n d t he E x peri me ntal S u bject's Bill of Ri g hts t o kee p.  
Y o u will be as ke d t o si g n a se parate f or m a ut h orizi n g access, use, creati o n, or discl os ure of healt h i nf or mati o n a b o ut y o u.  
P A R TI CI P A TI O N I N R E S E A R C H I S V O L U N T A R Y. Y o u ha ve t he ri g ht t o decli ne t o partici pate or t o wit h dra w at a n y p oi nt i n t his st u d y wit h o ut pe nalt y or l oss of be nefits t o w hic h y o u are ot her wise e ntitle d.  
If y o u wis h t o partici pate i n t his st u d y, y o u s h o ul d si g n bel o w.  
| Date   | Partici pa nt's Si g nat ure f or C o nse nt                                         |
|--------|--------------------------------------------------------------------------------------|
| Date   | Partici pa nt's Pri nte d Na me                                                      |
| Date   | Pers o n O btai ni n g C o nse nt                                                    |
| Date   | Wit ness - O nl y re q uire d if t he partici pa nt is a n o n- E n glis h s pea ker |

Y o u ha ve bee n gi ve n c o pies of t his c o nse nt f or m a n d t he E x peri me ntal S u bject's Bill of Ri g hts t o kee p.  
Y o u will be as ke d t o si g n a se parate f or m a ut h orizi n g access, use, creati o n, or discl os ure of healt h i nf or mati o n a b o ut y o u.  
P A R TI CI P A TI O N I N R E S E A R C H I S V O L U N T A R Y. Y o u ha ve t he ri g ht t o decli ne t o partici pate or t o wit h dra w at a n y p oi nt i n t his st u d y wit h o ut pe nalt y or l oss of be nefits t o w hic h y o u are ot her wise e ntitle d.  
If y o u wis h t o partici pate i n t his st u d y, y o u s h o ul d si g n bel o w.  
| Date   | Partici pa nt's Si g nat ure f or C o nse nt                                         |
|--------|--------------------------------------------------------------------------------------|
| Date   | Partici pa nt's Pri nte d Na me                                                      |
| Date   | Pers o n O btai ni n g C o nse nt                                                    |
| Date   | Wit ness - O nl y re q uire d if t he partici pa nt is a n o n- E n glis h s pea ker |
Clinical trial: NCT02494921
Section: Withdrawal from Study
Subsections: Wit H Dr A W Al Of Y O Ur C O Nse Nt T O P Artici P Ate I N T His St U D Y|Wit H Dr A W Al Of Y O Ur C O Nse Nt T O P Artici P Ate I N T His St U D Y|C A N I St O P Bei N G I N T He St U D Y ?|C A N I St O P Bei N G I N T He St U D Y ?|Wit H Dr A W Al Of Y O Ur C O Nse Nt T O P Artici P Ate I N T His St U D Y|Wit H Dr A W Al Of Y O Ur C O Nse Nt T O P Artici P Ate I N T His St U D Y|C A N I St O P Bei N G I N T He St U D Y ?|C A N I St O P Bei N G I N T He St U D Y ?

Y o u ma y deci de t hat y o u n ot o nl y wa nt t o st o p st u d y treat me nt b ut als o d o n ot wa nt t o c o me t o a n y f urt her visits, a n d d o n ot wa nt t o ha ve a n y f urt her assess me nts or c o ntact b y t he st u d y staff.  
T his is c o nsi dere d as wit h dra wal of y o ur c o nse nt fr o m partici pati o n i n t his st u d y. It is i m p orta nt t hat y o u i nf or m y o ur St u d y D oct or.  
U C S F will c o nti n ue t o retai n a n d use a n y researc h-relate d res ults t hat ha ve alrea d y bee n c ollecte d f or t he st u d y e val uati o n. N o f urt her st u d y-relate d acti vities will ta ke place.  
Y o u ca n disc uss f urt her re g ular me dical care wit h y o ur St u d y D oct or. T he c h oice t o wit h dra w fr o m researc h partici pati o n will n ot affect y o ur me dical care.  
St u d y l oc ati o n: All st u d y pr oce d ures will be d o ne at U C S F Hele n Diller Fa mil y C o m pre he nsi ve Ca ncer Ce nter.

Y o u ma y deci de t hat y o u n ot o nl y wa nt t o st o p st u d y treat me nt b ut als o d o n ot wa nt t o c o me t o a n y f urt her visits, a n d d o n ot wa nt t o ha ve a n y f urt her assess me nts or c o ntact b y t he st u d y staff.  
T his is c o nsi dere d as wit h dra wal of y o ur c o nse nt fr o m partici pati o n i n t his st u d y. It is i m p orta nt t hat y o u i nf or m y o ur St u d y D oct or.  
U C S F will c o nti n ue t o retai n a n d use a n y researc h-relate d res ults t hat ha ve alrea d y bee n c ollecte d f or t he st u d y e val uati o n. N o f urt her st u d y-relate d acti vities will ta ke place.  
Y o u ca n disc uss f urt her re g ular me dical care wit h y o ur St u d y D oct or. T he c h oice t o wit h dra w fr o m researc h partici pati o n will n ot affect y o ur me dical care.  
St u d y l oc ati o n: All st u d y pr oce d ures will be d o ne at U C S F Hele n Diller Fa mil y C o m pre he nsi ve Ca ncer Ce nter.

Yes. Y o u ca n deci de t o st o p at a n y ti me. Tell t he st u d y d oct or if y o u are t hi n ki n g a b o ut st o p pi n g or deci de t o st o p. S he will tell y o u h o w t o st o p y o ur partici pati o n safel y.  
It is i m p orta nt t o tell t he st u d y d oct or if y o u are t hi n ki n g a b o ut st o p pi n g s o a n y ris ks ca n be e val uate d b y y o ur d oct or. A n ot her reas o n t o tell y o ur d oct or t hat y o u are t hi n ki n g a b o ut st o p pi n g is t o disc uss w hat f oll o w- u p care a n d testi n g c o ul d be m ost hel pf ul f or y o u.  
T he st u d y d oct or ma y st o p y o u fr o m ta ki n g part i n t his st u d y at a n y ti me if s he belie ves it is i n y o ur best i nterest, if y o u d o n ot f oll o w t he st u d y r ules, or if t he st u d y is st o p pe d.

Yes. Y o u ca n deci de t o st o p at a n y ti me. Tell t he st u d y d oct or if y o u are t hi n ki n g a b o ut st o p pi n g or deci de t o st o p. S he will tell y o u h o w t o st o p y o ur partici pati o n safel y.  
It is i m p orta nt t o tell t he st u d y d oct or if y o u are t hi n ki n g a b o ut st o p pi n g s o a n y ris ks ca n be e val uate d b y y o ur d oct or. A n ot her reas o n t o tell y o ur d oct or t hat y o u are t hi n ki n g a b o ut st o p pi n g is t o disc uss w hat f oll o w- u p care a n d testi n g c o ul d be m ost hel pf ul f or y o u.  
T he st u d y d oct or ma y st o p y o u fr o m ta ki n g part i n t his st u d y at a n y ti me if s he belie ves it is i n y o ur best i nterest, if y o u d o n ot f oll o w t he st u d y r ules, or if t he st u d y is st o p pe d.

Y o u ma y deci de t hat y o u n ot o nl y wa nt t o st o p st u d y treat me nt b ut als o d o n ot wa nt t o c o me t o a n y f urt her visits, a n d d o n ot wa nt t o ha ve a n y f urt her assess me nts or c o ntact b y t he st u d y staff.  
T his is c o nsi dere d as wit h dra wal of y o ur c o nse nt fr o m partici pati o n i n t his st u d y. It is i m p orta nt t hat y o u i nf or m y o ur St u d y D oct or.  
U C S F will c o nti n ue t o retai n a n d use a n y researc h-relate d res ults t hat ha ve alrea d y bee n c ollecte d f or t he st u d y e val uati o n. N o f urt her st u d y-relate d acti vities will ta ke place.  
Y o u ca n disc uss f urt her re g ular me dical care wit h y o ur St u d y D oct or. T he c h oice t o wit h dra w fr o m researc h partici pati o n will n ot affect y o ur me dical care.  
St u d y l oc ati o n: All st u d y pr oce d ures will be d o ne at U C S F Hele n Diller Fa mil y C o m pre he nsi ve Ca ncer Ce nter.

Y o u ma y deci de t hat y o u n ot o nl y wa nt t o st o p st u d y treat me nt b ut als o d o n ot wa nt t o c o me t o a n y f urt her visits, a n d d o n ot wa nt t o ha ve a n y f urt her assess me nts or c o ntact b y t he st u d y staff.  
T his is c o nsi dere d as wit h dra wal of y o ur c o nse nt fr o m partici pati o n i n t his st u d y. It is i m p orta nt t hat y o u i nf or m y o ur St u d y D oct or.  
U C S F will c o nti n ue t o retai n a n d use a n y researc h-relate d res ults t hat ha ve alrea d y bee n c ollecte d f or t he st u d y e val uati o n. N o f urt her st u d y-relate d acti vities will ta ke place.  
Y o u ca n disc uss f urt her re g ular me dical care wit h y o ur St u d y D oct or. T he c h oice t o wit h dra w fr o m researc h partici pati o n will n ot affect y o ur me dical care.  
St u d y l oc ati o n: All st u d y pr oce d ures will be d o ne at U C S F Hele n Diller Fa mil y C o m pre he nsi ve Ca ncer Ce nter.

Yes. Y o u ca n deci de t o st o p at a n y ti me. Tell t he st u d y d oct or if y o u are t hi n ki n g a b o ut st o p pi n g or deci de t o st o p. S he will tell y o u h o w t o st o p y o ur partici pati o n safel y.  
It is i m p orta nt t o tell t he st u d y d oct or if y o u are t hi n ki n g a b o ut st o p pi n g s o a n y ris ks ca n be e val uate d b y y o ur d oct or. A n ot her reas o n t o tell y o ur d oct or t hat y o u are t hi n ki n g a b o ut st o p pi n g is t o disc uss w hat f oll o w- u p care a n d testi n g c o ul d be m ost hel pf ul f or y o u.  
T he st u d y d oct or ma y st o p y o u fr o m ta ki n g part i n t his st u d y at a n y ti me if s he belie ves it is i n y o ur best i nterest, if y o u d o n ot f oll o w t he st u d y r ules, or if t he st u d y is st o p pe d.

Yes. Y o u ca n deci de t o st o p at a n y ti me. Tell t he st u d y d oct or if y o u are t hi n ki n g a b o ut st o p pi n g or deci de t o st o p. S he will tell y o u h o w t o st o p y o ur partici pati o n safel y.  
It is i m p orta nt t o tell t he st u d y d oct or if y o u are t hi n ki n g a b o ut st o p pi n g s o a n y ris ks ca n be e val uate d b y y o ur d oct or. A n ot her reas o n t o tell y o ur d oct or t hat y o u are t hi n ki n g a b o ut st o p pi n g is t o disc uss w hat f oll o w- u p care a n d testi n g c o ul d be m ost hel pf ul f or y o u.  
T he st u d y d oct or ma y st o p y o u fr o m ta ki n g part i n t his st u d y at a n y ti me if s he belie ves it is i n y o ur best i nterest, if y o u d o n ot f oll o w t he st u d y r ules, or if t he st u d y is st o p pe d.