CompletedNCT00943917Updated Apr 13, 2015Results posted

Study of ITCA 650 (Exenatide in DUROS) in Subjects With Type 2 Diabetes Mellitus

A Phase 2 interventional study of ITCA 650 and Exenatide Injection in Type 2 Diabetes, sponsored by Intarcia Therapeutics. Completed at 50 sites in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2015-04-13.

Sponsored by Intarcia Therapeutics · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 155
Allocation: Randomized
Ages: 18 Years to 70 Years
Sex: All

Study summary

The purpose of this study is to determine safety, efficacy and tolerability of various doses of ITCA 650 in subjects with type 2 diabetes.

Conditions studied

Type 2 Diabetes

Browse trials for

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 155 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Intarcia Therapeutics is the lead sponsor of 21 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 70 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Males or females age 18-70 years
Type 2 diabetes mellitus for ≥ 6 months prior to Screening Visit 1
On a stable (> 3 months prior to Screening Visit 1) treatment regimen of metformin monotherapy;
Fasting plasma glucose \< 240 mg/dL at Screening Visit 1
HbA1c ≥ 7% and ≤ 10% at Screening Visit 1

Exclusion criteria

Exclusion Criteria:

Prior treatment with exenatide
Treatment with any of the following antidiabetic agents within 3 months prior to Screening Visit 1: TZDs, sulfonylureas, DPP IV inhibitors, acarbose, or insulin (injected or inhaled)
History of type 1 diabetes and/or history of diabetic ketoacidosis
Body mass index ≥ 40 kg/m2;
History of organ transplantation

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 155 participants (actual)

Study arms

Experimental
ITCA 650 20 mcg/day
Other: ITCA 650
Experimental
ITCA 650 40 mcg/day
Other: ITCA 650
Active comparator
Exenatide Injection
Drug: Exenatide Injection
Experimental
ITCA 650 20/20
Other: ITCA 650
Experimental
ITCA 650 20/60
Other: ITCA 650
Experimental
ITCA 650 40/40
Other: ITCA 650
Experimental
ITCA 650 40/80
Other: ITCA 650
Experimental
Ex Inj/ITCA 650 40
Other: Ex Inj/ITCA 650
Experimental
Ex Inj/ITCA 650 60
Other: Ex Inj/ITCA 650

Interventions

OtherITCA 650
ITCA 650 (continuous delivery of exenatide in DUROS)
DrugExenatide Injection
twice daily (BID) injections of exenatide commercially available Byetta: 5 mcg/dose first 12 weeks then 10 mcg/dose for 8 weeks
Also known as: Byetta
OtherEx Inj/ITCA 650
twice-daily (BID) exenatide injection: 5 mcg/dose for 4 weeks then 10 mcg/dose for 8 weeks, followed by ITCA 650
Also known as: Byetta

What researchers measure

Primary outcomes

Mean Change in HbA1c (Per Protocol)
Mean change in HbA1c over first 12 weeks (Stage I)
Time frame: Day 0 and Week 12
Mean Change in HbA1c (ITT)
Mean change in HbA1c through Week 12
Time frame: Day 0 to Week 12
Mean Change in HbA1c (Per Protocol)
Mean change in HbA1c through Week 24
Time frame: Day 0 to Week 24
Mean Change in HbA1c (ITT)
Mean change in HbA1c through Week 24
Time frame: Day 0 to Week 24
Mean Change in HbA1c (Per Protocol)
Mean change in HbA1c through Week 48
Time frame: Day 0 to Week 48
Mean Change in HbA1c (ITT)
Mean change in HbA1c through Week 48
Time frame: Day 0 to Week 48

Results

Posted May 3, 2012

Limitations and caveats

8 subjects (4 in 20, 1 in 40 and 3 in ex inj)completed StI but not randomized to St II; 3 subjects (2 in 20/20 \& 1 in 40/80) who completed St I, randomized to St II but not given study drug. St II Cont was optional, so not all pts elected to continue

Participant flow

Stage I

Participant flow — Stage I
Milestone	ITCA 650 20 mcg/Day- STAGE I	ITCA 650 40 mcg/Day- STAGE I	Exenatide Injection- STAGE I
Started	51	51	53
Completed	47	48	47
Not completed	4	3	6
Withdrew: Adverse event	1	2	2
Withdrew: Lost to follow-up	0	0	1
Withdrew: Hyperglycemia	0	0	1
Withdrew: A1c elevation	1	0	0
Withdrew: Withdrawal by subject	2	1	2

Stage II

Participant flow — Stage II
Milestone	ITCA 650 20/20- STAGE II	ITCA 650 20/60- STAGE II	ITCA 650 40/40 - STAGE II	ITCA 650 40/80 - STAGE II	Ex Inj/ITCA 650 40 mcg/Day- STAGE II	Ex Inj/ITCA 650 60 mcg/Day- STAGE II
Started	20	21	23	23	23	21
Completed	20	21	20	20	23	20
Not completed	0	0	3	3	0	1
Withdrew: Adverse event	0	0	1	3	0	1
Withdrew: Withdrawal by subject	0	0	1	0	0	0
Withdrew: Pregnancy	0	0	1	0	0	0

Stage II Continuation

Participant flow — Stage II Continuation
Milestone	ITCA 650 20/20 Continuation	ITCA 650 20/40 Continuation	ITCA 650 40/40 Contination	ITCA 650 40/80 Continuation	Ex Inj/ITCA 650 40 Continuation	Ex Inj/ITCA 650 60 Continuation
Started	15	15	13	16	15	12
Completed	14	15	11	13	12	8
Not completed	1	0	2	3	3	4
Withdrew: Adverse event	0	0	1	2	1	1
Withdrew: Withdrawal by subject	0	0	0	0	1	3
Withdrew: Protocol violation	1	0	1	0	0	0
Withdrew: Hypoglycemia	0	0	0	1	0	0
Withdrew: A1c elevation	0	0	0	0	1	0

Outcome measures

PrimaryMean Change in HbA1c (Per Protocol)

Mean change in HbA1c over first 12 weeks (Stage I)

Time frame:: Day 0 and Week 12
Reported as:: Mean · percent change

Mean Change in HbA1c (Per Protocol)
percent change	ITCA 650 20 mcg/Day - STAGE I	ITCA 650 40 mcg/Day - STAGE I	Exenatide Injection - STAGE I
Mean Change in HbA1c (Per Protocol)	-0.96 ± 0.905	-1.04 ± 0.713	-0.82 ± 0.870

PrimaryMean Change in HbA1c (ITT)

Mean change in HbA1c through Week 12

Time frame:: Day 0 to Week 12
Reported as:: Mean · percent change

Mean Change in HbA1c (ITT)
percent change	ITCA 650 20 mcg/Day - STAGE I	ITCA 650 40 mcg/Day - STAGE I	Exenatide Injection - STAGE I
Mean Change in HbA1c (ITT)	-.93 ± 0.882	-0.96 ± 0.724	-0.75 ± 0.866

PrimaryMean Change in HbA1c (Per Protocol)

Mean change in HbA1c through Week 24

Time frame:: Day 0 to Week 24
Reported as:: Mean · percent change

Mean Change in HbA1c (Per Protocol)
percent change	ITCA 650 20/20	ITCA 650 20/60	ITCA 650 40/40	ITCA 650 40/80	Ex Inj/ITCA 650 40	Ex Inj/ITCA 650 60
Mean Change in HbA1c (Per Protocol)	-.89 ± .660	-1.26 ± .950	-0.67 ± .908	-1.36 ± 0.664	-1.01 ± 0.823	-1.51 ± 1.266

PrimaryMean Change in HbA1c (ITT)

Mean change in HbA1c through Week 24

Time frame:: Day 0 to Week 24
Reported as:: Mean · percent change

Mean Change in HbA1c (ITT)
percent change	ITCA 650 20/20	ITCA 650 20/60	ITCA 650 40/40	ITCA 650 40/80	Ex Inj/ITCA 650 40	Ex Inj/ITCA 650 60
Mean Change in HbA1c (ITT)	-0.89 ± 0.660	-1.26 ± 0.950	-0.70 ± 0.892	-1.36 ± 0.664	-1.01 ± 0.823	-1.51 ± 1.266

PrimaryMean Change in HbA1c (Per Protocol)

Mean change in HbA1c through Week 48

Time frame:: Day 0 to Week 48
Reported as:: Mean · percent change

Mean Change in HbA1c (Per Protocol)
percent change	ITCA 650 20/20	ITCA 650 20/60	ITCA 650 40/40	ITCA 650 40/80	Ex Inj/ITCA 650 40	Ex Inj/ITCA 650 60
Mean Change in HbA1c (Per Protocol)	-1.00 ± 0.493	-1.23 ± 0.908	-0.69 ± 1.182	-1.37 ± 0.837	-1.45 ± 0.895	-1.88 ± 1.212

PrimaryMean Change in HbA1c (ITT)

Mean change in HbA1c through Week 48

Time frame:: Day 0 to Week 48
Reported as:: Mean · percent change

Mean Change in HbA1c (ITT)
percent change	ITCA 650 20/20	ITCA 650 20/60	ITCA 650 40/40	ITCA 650 40/80	Ex Inj/ITCA 650 40	Ex Inj/ITCA 650 60
Mean Change in HbA1c (ITT)	-1.13 ± 0.651	-1.25 ± 0.880	-0.48 ± 1.555	-1.40 ± 0.803	-1.16 ± 0.988	-1.84 ± 1.570

Adverse events

Collected over 48 weeks. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
ITCA 650 20 mcg/Day	—	1/51 (2%)	39/51 (76.5%)
ITCA 650 40 mcg/Day	—	0/51 (0%)	43/51 (84.3%)
Exenatide Injection	—	0/53 (0%)	38/53 (71.7%)
ITCA 650 20/20	—	1/20 (5%)	11/20 (55%)
ITCA 650 20/60	—	1/21 (4.8%)	15/21 (71.4%)
ITCA 650 40/40	—	2/23 (8.7%)	18/23 (78.3%)
ITCA 650 40/80	—	2/23 (8.7%)	18/23 (78.3%)
Ex Inj/ITCA 650 40	—	0/23 (0%)	18/23 (78.3%)
Ex Inj/ITCA 650 60	—	0/21 (0%)	18/21 (85.7%)
ITCA 650 20/20 Continuation	—	0/15 (0%)	2/15 (13.3%)
ITCA 650 20/60 Continuation	—	1/15 (6.7%)	3/15 (20%)
ITCA 650 40/40 Continuation	—	1/13 (7.7%)	3/13 (23.1%)
ITCA 650 40/80 Continuation	—	2/16 (12.5%)	6/16 (37.5%)
Ex Inj/ITCA 40 Continuation	—	0/15 (0%)	4/15 (26.7%)
Ex Inj/ITCA 650 60 Continutation	—	0/12 (0%)	4/12 (33.3%)

Most frequent serious events

Showing 10 of 13

Most frequent serious events
Event	ITCA 650 20 mcg/Day	ITCA 650 40 mcg/Day	Exenatide Injection	ITCA 650 20/20	ITCA 650 20/60	ITCA 650 40/40	ITCA 650 40/80	Ex Inj/ITCA 650 40	Ex Inj/ITCA 650 60	ITCA 650 20/20 Continuation	ITCA 650 20/60 Continuation	ITCA 650 40/40 Continuation	ITCA 650 40/80 Continuation	Ex Inj/ITCA 40 Continuation	Ex Inj/ITCA 650 60 Continutation
rectal cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps)	0/51	0/51	0/53	0/20	0/21	0/23	0/23	0/23	0/21	0/15	0/15	1/13	0/16	0/15	0/12
labyrinthitisInfections and infestations	0/51	0/51	0/53	0/20	0/21	0/23	0/23	0/23	0/21	0/15	1/15	0/13	0/16	0/15	0/12
myocardial infarctionCardiac disorders	0/51	0/51	0/53	0/20	0/21	0/23	0/23	0/23	0/21	0/15	0/15	0/13	1/16	0/15	0/12
subclavian artery stenosisVascular disorders	0/51	0/51	0/53	0/20	0/21	0/23	0/19	0/23	0/21	0/15	0/15	0/13	1/16	0/15	0/12
leukopeniaBlood and lymphatic system disorders	0/51	0/51	0/53	0/20	0/21	0/19	1/19	0/22	0/20	0/15	0/15	0/13	0/16	0/15	0/12
meningitis cryptococcalInfections and infestations	0/51	0/51	0/53	0/20	0/21	0/19	1/19	0/22	0/20	0/15	0/15	0/13	0/16	0/15	0/12
abortion, spontaneousPregnancy, puerperium and perinatal conditions	0/51	0/51	0/53	0/20	0/21	1/19	0/23	0/23	0/21	0/15	0/15	0/13	0/16	0/15	0/12
skin ulcerSkin and subcutaneous tissue disorders	0/51	0/51	0/53	1/20	0/21	0/23	0/23	0/23	0/21	0/15	0/15	0/13	0/16	0/15	0/12
prostatomegalyReproductive system and breast disorders	0/51	0/51	0/53	0/20	1/21	0/23	0/23	0/23	0/21	0/15	0/15	0/13	0/16	0/15	0/12
pyrexiaGeneral disorders	0/51	0/51	0/53	0/20	0/21	0/23	1/23	0/23	0/21	0/15	0/15	0/13	0/16	0/15	0/12

Most frequent other events

Showing 10 of 18

Most frequent other events
Event	ITCA 650 20 mcg/Day	ITCA 650 40 mcg/Day	Exenatide Injection	ITCA 650 20/20	ITCA 650 20/60	ITCA 650 40/40	ITCA 650 40/80	Ex Inj/ITCA 650 40	Ex Inj/ITCA 650 60	ITCA 650 20/20 Continuation	ITCA 650 20/60 Continuation	ITCA 650 40/40 Continuation	ITCA 650 40/80 Continuation	Ex Inj/ITCA 40 Continuation	Ex Inj/ITCA 650 60 Continutation
nauseaGastrointestinal disorders	17/51	24/51	19/53	2/20	7/21	1/23	6/23	1/23	8/21	0/15	0/15	0/13	0/16	0/15	0/12
incision site hematomaInjury, poisoning and procedural complications	8/51	8/51	0/53	5/20	2/21	3/23	3/23	2/23	5/21	0/15	0/15	0/13	0/16	0/15	0/12
vomitingGastrointestinal disorders	6/51	9/51	4/53	1/20	0/21	1/23	5/23	1/23	5/21	0/15	0/15	0/13	0/16	0/15	0/12
incision site painInjury, poisoning and procedural complications	0/51	0/51	0/53	3/20	2/21	5/23	3/23	3/23	2/21	0/15	1/15	0/13	3/16	1/15	1/12
diarrheaGastrointestinal disorders	2/51	8/51	3/53	1/20	2/21	1/23	3/23	4/23	4/21	0/15	0/15	0/13	0/16	0/15	0/12
constipationGastrointestinal disorders	3/51	4/51	1/53	0/20	0/21	2/23	0/23	3/23	4/21	0/15	0/15	0/13	0/16	0/15	0/12
urinary tract infectionInfections and infestations	0/51	0/51	0/53	1/20	1/21	4/23	1/23	1/23	1/21	2/15	2/15	1/13	0/16	2/15	0/12
incision site complicationInjury, poisoning and procedural complications	0/51	0/51	0/53	1/20	1/21	2/23	2/23	0/23	1/21	1/15	1/15	0/13	1/16	1/15	2/12
incision site pruritisInjury, poisoning and procedural complications	3/51	7/51	0/53	0/20	1/21	2/23	2/23	2/23	0/21	0/15	0/15	1/13	0/16	0/15	0/12
decreased appetiteMetabolism and nutrition disorders	6/51	7/51	5/53	1/20	1/21	2/23	2/23	2/23	1/21	0/15	0/15	0/13	0/16	0/15	0/12

Baseline characteristics

Age, Continuous
Age, Continuous(years)	ITCA 650 20 mcg/Day- STAGE I	ITCA 650 40 mcg/Day- STAGE I	Exenatide Injection- STAGE I	ITCA 650 20/20- STAGE II	ITCA 650 20/60- STAGE II	ITCA 650 40/40 - STAGE II	ITCA 650 40/80 - STAGE II	Ex Inj/ITCA 650 40 mcg/Day- STAGE II	Ex Inj/ITCA 650 60 mcg/Day- STAGE II	ITCA 650 20/20 Continuation	ITCA 650 20/40 Continuation	ITCA 650 40/40 Contination	ITCA 650 40/80 Continuation	Ex Inj/ITCA 650 40 Continuation	Ex Inj/ITCA 650 60 Continuation	Total
Mean	54.0 ± 8.3	53.3 ± 8.9	53.8 ± 9.6	—	—	—	—	—	—	—	—	—	—	—	—	53.7 ± 8.9

Age, Customized
Age, Customized(participants)	ITCA 650 20 mcg/Day- STAGE I	ITCA 650 40 mcg/Day- STAGE I	Exenatide Injection- STAGE I	ITCA 650 20/20- STAGE II	ITCA 650 20/60- STAGE II	ITCA 650 40/40 - STAGE II	ITCA 650 40/80 - STAGE II	Ex Inj/ITCA 650 40 mcg/Day- STAGE II	Ex Inj/ITCA 650 60 mcg/Day- STAGE II	ITCA 650 20/20 Continuation	ITCA 650 20/40 Continuation	ITCA 650 40/40 Contination	ITCA 650 40/80 Continuation	Ex Inj/ITCA 650 40 Continuation	Ex Inj/ITCA 650 60 Continuation	Total
<=18 years	0	0	0	—	—	—	—	—	—	—	—	—	—	—	—	0
Between 18 and 60 years	41	37	39	—	—	—	—	—	—	—	—	—	—	—	—	117
>=60 years	10	14	14	—	—	—	—	—	—	—	—	—	—	—	—	38

Gender
Gender(participants)	ITCA 650 20 mcg/Day- STAGE I	ITCA 650 40 mcg/Day- STAGE I	Exenatide Injection- STAGE I	ITCA 650 20/20- STAGE II	ITCA 650 20/60- STAGE II	ITCA 650 40/40 - STAGE II	ITCA 650 40/80 - STAGE II	Ex Inj/ITCA 650 40 mcg/Day- STAGE II	Ex Inj/ITCA 650 60 mcg/Day- STAGE II	ITCA 650 20/20 Continuation	ITCA 650 20/40 Continuation	ITCA 650 40/40 Contination	ITCA 650 40/80 Continuation	Ex Inj/ITCA 650 40 Continuation	Ex Inj/ITCA 650 60 Continuation	Total
Female	26	28	24	—	—	—	—	—	—	—	—	—	—	—	—	78
Male	25	23	29	—	—	—	—	—	—	—	—	—	—	—	—	77

Region of Enrollment
Region of Enrollment(participants)	ITCA 650 20 mcg/Day- STAGE I	ITCA 650 40 mcg/Day- STAGE I	Exenatide Injection- STAGE I	ITCA 650 20/20- STAGE II	ITCA 650 20/60- STAGE II	ITCA 650 40/40 - STAGE II	ITCA 650 40/80 - STAGE II	Ex Inj/ITCA 650 40 mcg/Day- STAGE II	Ex Inj/ITCA 650 60 mcg/Day- STAGE II	ITCA 650 20/20 Continuation	ITCA 650 20/40 Continuation	ITCA 650 40/40 Contination	ITCA 650 40/80 Continuation	Ex Inj/ITCA 650 40 Continuation	Ex Inj/ITCA 650 60 Continuation	Total
United States	51	51	53	—	—	—	—	—	—	—	—	—	—	—	—	155

Study locations

50 sites

Study Site
Chino, California 91710, United States
Study Site
La Jolla, California 92037, United States
Study Site
National City, California 91950, United States
Study Site
Sacramento, California 95821, United States
Study Site
San Diego, California 92161, United States
Study Site
Valley Village, California 91607, United States
Study Site
Longmont, Colorado 80501, United States
Study Site
Pueblo, Colorado 81001, United States
Study Site
Bradenton, Florida 34203, United States
Study Site
Miami, Florida 33143, United States
Study Site
Miami, Florida 33169, United States
Study Site
Miami, Florida 33183, United States
Study Site
Miramar, Florida 33025, United States
Study Site
Pembroke Pines, Florida 33026, United States
Study Site
St Petersburg, Florida 33709, United States
Study Site
Atlanta, Georgia 30342, United States
Study Site
Sandy Springs, Georgia 30328, United States
Study Site
Meridian, Idaho 83642, United States
Study Site
Chicago, Illinois 60607, United States
Study Site
Avon, Indiana 46123, United States
Study Site
Wichita, Kansas 67205, United States
Study Site
Lexington, Kentucky 40503, United States
Study Site
New Orleans, Louisiana 70112, United States
Study Site
Kalamazoo, Michigan 49007, United States
Study Site
Traverse City, Michigan 49684, United States
Study Site
Troy, Michigan 48098, United States
Study Site
Ypsilanti, Michigan 48197, United States
Study Site
Minneapolis, Minnesota 55416, United States
Study Site
Las Vegas, Nevada 89119, United States
Study Site
New Hyde Park, New York 11042, United States
Study Site
Charlotte, North Carolina 28209, United States
Study Site
Hickory, North Carolina 28601, United States
Study Site
Cincinatti, Ohio 45212, United States
Study Site
Cincinnati, Ohio 45219, United States
Study Site
Franklin, Ohio 45005, United States
Study Site
Kettering, Ohio 45429, United States
Study Site
Norman, Oklahoma 73069, United States
Study Site
Eugene, Oregon 97404, United States
Study Site
Rapid City, South Dakota 57702, United States
Study Site
Austin, Texas 78749, United States
Study Site
Austin, Texas 78752, United States
Study Site
Dallas, Texas 75230, United States
Study Site
Dallas, Texas 75251, United States
Study Site
Irving, Texas 75039, United States
Study Site
San Antonio, Texas 78205, United States
Study Site
San Antonio, Texas 78229, United States
Study Site
West Jordan, Utah 84088, United States
Study Site
Norfolk, Virginia 23502, United States
Study Site
Olympia, Washington 98502, United States
Study Site
Spokane, Washington 99202, United States

References and documents

Publications

Henry RR, Rosenstock J, Logan DK, Alessi TR, Luskey K, Baron MA. Randomized trial of continuous subcutaneous delivery of exenatide by ITCA 650 versus twice-daily exenatide injections in metformin-treated type 2 diabetes. Diabetes Care. 2013 Sep;36(9):2559-65. doi: 10.2337/dc12-2410. Epub 2013 May 3. Erratum In: Diabetes Care. 2014 Jan;37(1):312. Dosage error in article text. PubMed 23645886 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Apr 13, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00943917
Lead sponsor: Intarcia Therapeutics
Responsible party: Sponsor
First posted: Jul 22, 2009
Start date: Aug 2009
Primary completion: Aug 2010
Completion: Feb 2011
Results posted: May 3, 2012
Last update: Apr 13, 2015

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.

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Study of ITCA 650 (Exenatide in DUROS) in Subjects With Type 2 Diabetes Mellitus

Study summary

Conditions studied

Browse trials for

In context

Diabetes Mellitus

Lead sponsor

Who can participate

✓Inclusion criteria

✕Exclusion criteria

Study design

Study arms

Interventions

What researchers measure

Primary outcomes

Results

Participant flow

Outcome measures

Adverse events

Baseline characteristics

Study locations

References and documents

Publications

Updates

Registry details

Key details

Oversight

Not currently enrolling

Follow this study

Discussion

Other studies in this condition

Other studies from this sponsor

Inclusion criteria

Exclusion criteria