Trial Outcomes & Findings for A Comparison of Once a Day Dose Compared to 2 Doses/Day (NCT NCT00505778)

Last Updated: 2013-04-22

Results Overview

Remission defined as SCCAI \<5. Simple Clinical Colitis Activity Index: minimum score 0, maximum score 19, reflects disease activity over the 24 hours prior to completion. Composite Score: bowel frequency (day, 0-3) (night, 0-2), defecation urgency (0-3), blood in stool (0-3), general well being (0-4), extracolonic features (arthritis, pyoderma gangrenosum, erythema nodosum, uveitis - 1 per manifestation).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

1027 participants

Primary outcome timeframe

6 months

Results posted on

2013-04-22

Participant Flow

Enrollment began 9 Aug 2007

Participant milestones

Participant milestones
Measure	Mesalamine Once-Daily an oral, once daily (QD) mesalamine regimen (1.6 - 2.4 g/day)	Mesalamine Twice-Daily an oral, twice daily (BID) mesalamine regimen (1.6 - 2.4 g/day)
Overall Study STARTED	514	513
Overall Study Intent to Treat (ITT) Population	512	511
Overall Study COMPLETED	380	378
Overall Study NOT COMPLETED	134	135

Reasons for withdrawal

Reasons for withdrawal
Measure	Mesalamine Once-Daily an oral, once daily (QD) mesalamine regimen (1.6 - 2.4 g/day)	Mesalamine Twice-Daily an oral, twice daily (BID) mesalamine regimen (1.6 - 2.4 g/day)
Overall Study Adverse Event	2	7
Overall Study Physician Decision	8	14
Overall Study Lost to Follow-up	17	23
Overall Study Unable to Meet Protocol Criteria	4	1
Overall Study Protocol Violation	7	9
Overall Study Withdrawal by Subject	29	14
Overall Study Relapse	65	65
Overall Study Took No Study Drug	2	2

Baseline Characteristics

A Comparison of Once a Day Dose Compared to 2 Doses/Day

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Mesalamine Once-Daily n=514 Participants an oral, once daily (QD) mesalamine regimen (1.6 - 2.4 g/day)	Mesalamine Twice-Daily n=513 Participants an oral, twice daily (BID) mesalamine regimen (1.6 - 2.4 g/day)	Total n=1027 Participants Total of all reporting groups
Age, Customized < 65 years old	409 Participants n=5 Participants	414 Participants n=7 Participants	823 Participants n=5 Participants
Age, Customized > = 65 years old	103 Participants n=5 Participants	97 Participants n=7 Participants	200 Participants n=5 Participants
Gender Female	261 participants n=5 Participants	268 participants n=7 Participants	529 participants n=5 Participants
Gender Male	251 participants n=5 Participants	243 participants n=7 Participants	494 participants n=5 Participants
Region of Enrollment Canada	6 participants n=5 Participants	8 participants n=7 Participants	14 participants n=5 Participants
Region of Enrollment United States	506 participants n=5 Participants	503 participants n=7 Participants	1009 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Population: ITT Population

Outcome measures

Outcome measures
Measure	Mesalamine Once-Daily n=512 Participants an oral, once daily (QD) mesalamine regimen (1.6 - 2.4 g/day)	Mesalamine Twice-Daily n=511 Participants an oral, twice daily (BID) mesalamine regimen (1.6 - 2.4 g/day)
Percentage of Patients Remaining in Remission at Month 6, ITT Population, Determined by the Simple Clinical Colitis Activity Index (SCCAI)	90.5 Percentage of Participants	91.8 Percentage of Participants

SECONDARY outcome

Timeframe: 3 months

Population: ITT Population

Remission defined as SCCAI \< 5. Simple Clinical Colitis Activity Index: minimum score 0, maximum score 19, reflects disease activity over the 24 hours prior to completion. Composite Score: bowel frequency (day, 0-3) (night, 0-2), defecation urgency (0-3), blood in stool (0-3), general well being (0-4), extracolonic features (arthritis, pyoderma gangrenosum, erythema nodosum, uveitis - 1 per manifestation).

Outcome measures

Outcome measures
Measure	Mesalamine Once-Daily n=512 Participants an oral, once daily (QD) mesalamine regimen (1.6 - 2.4 g/day)	Mesalamine Twice-Daily n=511 Participants an oral, twice daily (BID) mesalamine regimen (1.6 - 2.4 g/day)
Percentage of Patients Remaining in Remission at Month 3, ITT Population	94.8 Percentage of Participants	95.6 Percentage of Participants

SECONDARY outcome

Timeframe: 12 months

Population: ITT Population

Remission defined as SCCAI score \< 5. Simple Clinical Colitis Activity Index: minimum score 0, maximum score 19, reflects disease activity over the 24 hours prior to completion. Composite Score: bowel frequency (day, 0-3) (night, 0-2), defecation urgency (0-3), blood in stool (0-3), general well being (0-4), extracolonic features (arthritis, pyoderma gangrenosum, erythema nodosum, uveitis - 1 per manifestation).

Outcome measures

Outcome measures
Measure	Mesalamine Once-Daily n=512 Participants an oral, once daily (QD) mesalamine regimen (1.6 - 2.4 g/day)	Mesalamine Twice-Daily n=511 Participants an oral, twice daily (BID) mesalamine regimen (1.6 - 2.4 g/day)
Percentage of Patients Remaining in Remission at Month 12, ITT Population	85.4 Percentage of Participants	85.4 Percentage of Participants

SECONDARY outcome

Timeframe: 6 months

Population: ITT Population

Relapse/flare is defined as SCCAI \>= 5. Simple Clinical Colitis Activity Index: minimum score 0, maximum score 19, reflects disease activity over the 24 hours prior to completion. Composite Score: bowel frequency (day, 0-3) (night, 0-2), defecation urgency (0-3), blood in stool (0-3), general well being (0-4), extracolonic features (arthritis, pyoderma gangrenosum, erythema nodosum, uveitis - 1 per manifestation).

Outcome measures

Outcome measures
Measure	Mesalamine Once-Daily n=512 Participants an oral, once daily (QD) mesalamine regimen (1.6 - 2.4 g/day)	Mesalamine Twice-Daily n=511 Participants an oral, twice daily (BID) mesalamine regimen (1.6 - 2.4 g/day)
Number of Subjects Who Relapse/Flare Within 6 Months, ITT Population	45 Participants	39 Participants

SECONDARY outcome

Timeframe: 6 months

Population: ITT Population

MARS: Composite score for the following statements: I change how many times per day I take my medicine, I forget to use it, I stop taking it for a while, I only use it when I am having active symptoms, I decide to miss out on a dose, I take less than instructed, I take more than instructed, I avoid using it if I can, I use it regularly every day (reverse scored): 5-never, 4-rarely, 3-sometimes, 2-often, 1-very often. Minimum score 9, maximum score 45.

Outcome measures

Outcome measures
Measure	Mesalamine Once-Daily n=512 Participants an oral, once daily (QD) mesalamine regimen (1.6 - 2.4 g/day)	Mesalamine Twice-Daily n=511 Participants an oral, twice daily (BID) mesalamine regimen (1.6 - 2.4 g/day)
Total MARS (Medication Adherence Report Scale) Questionnaire Scores, ITT Population, Month 6	42.3 MARS Score Standard Error 0.23	41.8 MARS Score Standard Error 0.24

SECONDARY outcome

Timeframe: 6 months

Population: ITT Population

Is your ulcerative colitis in remission (not active)? Y/N

Outcome measures

Outcome measures
Measure	Mesalamine Once-Daily n=512 Participants an oral, once daily (QD) mesalamine regimen (1.6 - 2.4 g/day)	Mesalamine Twice-Daily n=511 Participants an oral, twice daily (BID) mesalamine regimen (1.6 - 2.4 g/day)
Percentage of Participants Indicating Ulcerative Colitis in Remission (Patient Defined Remission Index), ITT Population, Month 6	83.1 Percentage of Participants	86.6 Percentage of Participants

Adverse Events

Mesalamine Once-Daily

Serious events: 18 serious events

Other events: 0 other events

Deaths: 0 deaths

Mesalamine Twice-Daily

Serious events: 9 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Adverse event data not reported

Additional Information

Grexan Wulff, Manager Regulatory Affairs

Warner Chilcott

Phone: 973-442-3376

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60

Measure	Mesalamine Once-Daily n=512 participants at risk an oral, once daily (QD) mesalamine regimen (1.6 - 2.4 g/day)	Mesalamine Twice-Daily n=511 participants at risk an oral, twice daily (BID) mesalamine regimen (1.6 - 2.4 g/day)
Gastrointestinal disorders Abdominal Pain	0.00% 0/512 • 12 months ITT Population, Only Immediately Reportable Events (SAEs or withdrawal due to AEs) collected for this study. Data collected between 9 Aug 2007 and 29 Jul 2009.	0.20% 1/511 • 12 months ITT Population, Only Immediately Reportable Events (SAEs or withdrawal due to AEs) collected for this study. Data collected between 9 Aug 2007 and 29 Jul 2009.
Gastrointestinal disorders Ascites	0.00% 0/512 • 12 months ITT Population, Only Immediately Reportable Events (SAEs or withdrawal due to AEs) collected for this study. Data collected between 9 Aug 2007 and 29 Jul 2009.	0.20% 1/511 • 12 months ITT Population, Only Immediately Reportable Events (SAEs or withdrawal due to AEs) collected for this study. Data collected between 9 Aug 2007 and 29 Jul 2009.
Gastrointestinal disorders Constipation	0.00% 0/512 • 12 months ITT Population, Only Immediately Reportable Events (SAEs or withdrawal due to AEs) collected for this study. Data collected between 9 Aug 2007 and 29 Jul 2009.	0.20% 1/511 • 12 months ITT Population, Only Immediately Reportable Events (SAEs or withdrawal due to AEs) collected for this study. Data collected between 9 Aug 2007 and 29 Jul 2009.
Gastrointestinal disorders Rectal Haemorrhage	0.00% 0/512 • 12 months ITT Population, Only Immediately Reportable Events (SAEs or withdrawal due to AEs) collected for this study. Data collected between 9 Aug 2007 and 29 Jul 2009.	0.20% 1/511 • 12 months ITT Population, Only Immediately Reportable Events (SAEs or withdrawal due to AEs) collected for this study. Data collected between 9 Aug 2007 and 29 Jul 2009.
Gastrointestinal disorders Anal fistula	0.20% 1/512 • 12 months ITT Population, Only Immediately Reportable Events (SAEs or withdrawal due to AEs) collected for this study. Data collected between 9 Aug 2007 and 29 Jul 2009.	0.00% 0/511 • 12 months ITT Population, Only Immediately Reportable Events (SAEs or withdrawal due to AEs) collected for this study. Data collected between 9 Aug 2007 and 29 Jul 2009.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast Cancer	0.00% 0/512 • 12 months ITT Population, Only Immediately Reportable Events (SAEs or withdrawal due to AEs) collected for this study. Data collected between 9 Aug 2007 and 29 Jul 2009.	0.20% 1/511 • 12 months ITT Population, Only Immediately Reportable Events (SAEs or withdrawal due to AEs) collected for this study. Data collected between 9 Aug 2007 and 29 Jul 2009.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal Carcinoma	0.00% 0/512 • 12 months ITT Population, Only Immediately Reportable Events (SAEs or withdrawal due to AEs) collected for this study. Data collected between 9 Aug 2007 and 29 Jul 2009.	0.20% 1/511 • 12 months ITT Population, Only Immediately Reportable Events (SAEs or withdrawal due to AEs) collected for this study. Data collected between 9 Aug 2007 and 29 Jul 2009.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small Cell Lung Cancer Metastatic	0.00% 0/512 • 12 months ITT Population, Only Immediately Reportable Events (SAEs or withdrawal due to AEs) collected for this study. Data collected between 9 Aug 2007 and 29 Jul 2009.	0.20% 1/511 • 12 months ITT Population, Only Immediately Reportable Events (SAEs or withdrawal due to AEs) collected for this study. Data collected between 9 Aug 2007 and 29 Jul 2009.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal Cancer	0.20% 1/512 • 12 months ITT Population, Only Immediately Reportable Events (SAEs or withdrawal due to AEs) collected for this study. Data collected between 9 Aug 2007 and 29 Jul 2009.	0.00% 0/511 • 12 months ITT Population, Only Immediately Reportable Events (SAEs or withdrawal due to AEs) collected for this study. Data collected between 9 Aug 2007 and 29 Jul 2009.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thyroid Neoplasm	0.20% 1/512 • 12 months ITT Population, Only Immediately Reportable Events (SAEs or withdrawal due to AEs) collected for this study. Data collected between 9 Aug 2007 and 29 Jul 2009.	0.00% 0/511 • 12 months ITT Population, Only Immediately Reportable Events (SAEs or withdrawal due to AEs) collected for this study. Data collected between 9 Aug 2007 and 29 Jul 2009.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine Leiomyoma	0.20% 1/512 • 12 months ITT Population, Only Immediately Reportable Events (SAEs or withdrawal due to AEs) collected for this study. Data collected between 9 Aug 2007 and 29 Jul 2009.	0.00% 0/511 • 12 months ITT Population, Only Immediately Reportable Events (SAEs or withdrawal due to AEs) collected for this study. Data collected between 9 Aug 2007 and 29 Jul 2009.
Cardiac disorders Cardiomyopathy	0.00% 0/512 • 12 months ITT Population, Only Immediately Reportable Events (SAEs or withdrawal due to AEs) collected for this study. Data collected between 9 Aug 2007 and 29 Jul 2009.	0.20% 1/511 • 12 months ITT Population, Only Immediately Reportable Events (SAEs or withdrawal due to AEs) collected for this study. Data collected between 9 Aug 2007 and 29 Jul 2009.
Cardiac disorders Coronary Artery Disease	0.00% 0/512 • 12 months ITT Population, Only Immediately Reportable Events (SAEs or withdrawal due to AEs) collected for this study. Data collected between 9 Aug 2007 and 29 Jul 2009.	0.20% 1/511 • 12 months ITT Population, Only Immediately Reportable Events (SAEs or withdrawal due to AEs) collected for this study. Data collected between 9 Aug 2007 and 29 Jul 2009.
Cardiac disorders Atrial Fibrillation	0.20% 1/512 • 12 months ITT Population, Only Immediately Reportable Events (SAEs or withdrawal due to AEs) collected for this study. Data collected between 9 Aug 2007 and 29 Jul 2009.	0.00% 0/511 • 12 months ITT Population, Only Immediately Reportable Events (SAEs or withdrawal due to AEs) collected for this study. Data collected between 9 Aug 2007 and 29 Jul 2009.
Cardiac disorders Cardiac Failure Congestive	0.20% 1/512 • 12 months ITT Population, Only Immediately Reportable Events (SAEs or withdrawal due to AEs) collected for this study. Data collected between 9 Aug 2007 and 29 Jul 2009.	0.00% 0/511 • 12 months ITT Population, Only Immediately Reportable Events (SAEs or withdrawal due to AEs) collected for this study. Data collected between 9 Aug 2007 and 29 Jul 2009.
Cardiac disorders Myocardial Infarcation	0.20% 1/512 • 12 months ITT Population, Only Immediately Reportable Events (SAEs or withdrawal due to AEs) collected for this study. Data collected between 9 Aug 2007 and 29 Jul 2009.	0.00% 0/511 • 12 months ITT Population, Only Immediately Reportable Events (SAEs or withdrawal due to AEs) collected for this study. Data collected between 9 Aug 2007 and 29 Jul 2009.
Renal and urinary disorders Renal Failure Acute	0.00% 0/512 • 12 months ITT Population, Only Immediately Reportable Events (SAEs or withdrawal due to AEs) collected for this study. Data collected between 9 Aug 2007 and 29 Jul 2009.	0.39% 2/511 • 12 months ITT Population, Only Immediately Reportable Events (SAEs or withdrawal due to AEs) collected for this study. Data collected between 9 Aug 2007 and 29 Jul 2009.
Metabolism and nutrition disorders Dehydration	0.00% 0/512 • 12 months ITT Population, Only Immediately Reportable Events (SAEs or withdrawal due to AEs) collected for this study. Data collected between 9 Aug 2007 and 29 Jul 2009.	0.20% 1/511 • 12 months ITT Population, Only Immediately Reportable Events (SAEs or withdrawal due to AEs) collected for this study. Data collected between 9 Aug 2007 and 29 Jul 2009.
Metabolism and nutrition disorders Hyponatraemia	0.20% 1/512 • 12 months ITT Population, Only Immediately Reportable Events (SAEs or withdrawal due to AEs) collected for this study. Data collected between 9 Aug 2007 and 29 Jul 2009.	0.00% 0/511 • 12 months ITT Population, Only Immediately Reportable Events (SAEs or withdrawal due to AEs) collected for this study. Data collected between 9 Aug 2007 and 29 Jul 2009.
Respiratory, thoracic and mediastinal disorders Pulmonary Embolism	0.00% 0/512 • 12 months ITT Population, Only Immediately Reportable Events (SAEs or withdrawal due to AEs) collected for this study. Data collected between 9 Aug 2007 and 29 Jul 2009.	0.20% 1/511 • 12 months ITT Population, Only Immediately Reportable Events (SAEs or withdrawal due to AEs) collected for this study. Data collected between 9 Aug 2007 and 29 Jul 2009.
Respiratory, thoracic and mediastinal disorders Haemothorax	0.20% 1/512 • 12 months ITT Population, Only Immediately Reportable Events (SAEs or withdrawal due to AEs) collected for this study. Data collected between 9 Aug 2007 and 29 Jul 2009.	0.00% 0/511 • 12 months ITT Population, Only Immediately Reportable Events (SAEs or withdrawal due to AEs) collected for this study. Data collected between 9 Aug 2007 and 29 Jul 2009.
Vascular disorders Deep Vein Thrombosis	0.00% 0/512 • 12 months ITT Population, Only Immediately Reportable Events (SAEs or withdrawal due to AEs) collected for this study. Data collected between 9 Aug 2007 and 29 Jul 2009.	0.20% 1/511 • 12 months ITT Population, Only Immediately Reportable Events (SAEs or withdrawal due to AEs) collected for this study. Data collected between 9 Aug 2007 and 29 Jul 2009.
Vascular disorders Hypertension	0.20% 1/512 • 12 months ITT Population, Only Immediately Reportable Events (SAEs or withdrawal due to AEs) collected for this study. Data collected between 9 Aug 2007 and 29 Jul 2009.	0.00% 0/511 • 12 months ITT Population, Only Immediately Reportable Events (SAEs or withdrawal due to AEs) collected for this study. Data collected between 9 Aug 2007 and 29 Jul 2009.
Vascular disorders Thrombophlebitis	0.20% 1/512 • 12 months ITT Population, Only Immediately Reportable Events (SAEs or withdrawal due to AEs) collected for this study. Data collected between 9 Aug 2007 and 29 Jul 2009.	0.00% 0/511 • 12 months ITT Population, Only Immediately Reportable Events (SAEs or withdrawal due to AEs) collected for this study. Data collected between 9 Aug 2007 and 29 Jul 2009.
Hepatobiliary disorders Cholangitis	0.20% 1/512 • 12 months ITT Population, Only Immediately Reportable Events (SAEs or withdrawal due to AEs) collected for this study. Data collected between 9 Aug 2007 and 29 Jul 2009.	0.00% 0/511 • 12 months ITT Population, Only Immediately Reportable Events (SAEs or withdrawal due to AEs) collected for this study. Data collected between 9 Aug 2007 and 29 Jul 2009.
Hepatobiliary disorders Cholelithiasis	0.39% 2/512 • 12 months ITT Population, Only Immediately Reportable Events (SAEs or withdrawal due to AEs) collected for this study. Data collected between 9 Aug 2007 and 29 Jul 2009.	0.00% 0/511 • 12 months ITT Population, Only Immediately Reportable Events (SAEs or withdrawal due to AEs) collected for this study. Data collected between 9 Aug 2007 and 29 Jul 2009.
Hepatobiliary disorders Jaundice Cholestatic	0.20% 1/512 • 12 months ITT Population, Only Immediately Reportable Events (SAEs or withdrawal due to AEs) collected for this study. Data collected between 9 Aug 2007 and 29 Jul 2009.	0.00% 0/511 • 12 months ITT Population, Only Immediately Reportable Events (SAEs or withdrawal due to AEs) collected for this study. Data collected between 9 Aug 2007 and 29 Jul 2009.
Infections and infestations Appendicitis	0.39% 2/512 • 12 months ITT Population, Only Immediately Reportable Events (SAEs or withdrawal due to AEs) collected for this study. Data collected between 9 Aug 2007 and 29 Jul 2009.	0.00% 0/511 • 12 months ITT Population, Only Immediately Reportable Events (SAEs or withdrawal due to AEs) collected for this study. Data collected between 9 Aug 2007 and 29 Jul 2009.
Infections and infestations Diverticulitis	0.20% 1/512 • 12 months ITT Population, Only Immediately Reportable Events (SAEs or withdrawal due to AEs) collected for this study. Data collected between 9 Aug 2007 and 29 Jul 2009.	0.00% 0/511 • 12 months ITT Population, Only Immediately Reportable Events (SAEs or withdrawal due to AEs) collected for this study. Data collected between 9 Aug 2007 and 29 Jul 2009.
Injury, poisoning and procedural complications Clavicle Fracture	0.20% 1/512 • 12 months ITT Population, Only Immediately Reportable Events (SAEs or withdrawal due to AEs) collected for this study. Data collected between 9 Aug 2007 and 29 Jul 2009.	0.00% 0/511 • 12 months ITT Population, Only Immediately Reportable Events (SAEs or withdrawal due to AEs) collected for this study. Data collected between 9 Aug 2007 and 29 Jul 2009.
Injury, poisoning and procedural complications Rib Fracture	0.20% 1/512 • 12 months ITT Population, Only Immediately Reportable Events (SAEs or withdrawal due to AEs) collected for this study. Data collected between 9 Aug 2007 and 29 Jul 2009.	0.00% 0/511 • 12 months ITT Population, Only Immediately Reportable Events (SAEs or withdrawal due to AEs) collected for this study. Data collected between 9 Aug 2007 and 29 Jul 2009.
Injury, poisoning and procedural complications Spinal Compression Fracture	0.20% 1/512 • 12 months ITT Population, Only Immediately Reportable Events (SAEs or withdrawal due to AEs) collected for this study. Data collected between 9 Aug 2007 and 29 Jul 2009.	0.00% 0/511 • 12 months ITT Population, Only Immediately Reportable Events (SAEs or withdrawal due to AEs) collected for this study. Data collected between 9 Aug 2007 and 29 Jul 2009.
Nervous system disorders Altered State of Consciousness	0.20% 1/512 • 12 months ITT Population, Only Immediately Reportable Events (SAEs or withdrawal due to AEs) collected for this study. Data collected between 9 Aug 2007 and 29 Jul 2009.	0.00% 0/511 • 12 months ITT Population, Only Immediately Reportable Events (SAEs or withdrawal due to AEs) collected for this study. Data collected between 9 Aug 2007 and 29 Jul 2009.
Nervous system disorders Convulsion	0.20% 1/512 • 12 months ITT Population, Only Immediately Reportable Events (SAEs or withdrawal due to AEs) collected for this study. Data collected between 9 Aug 2007 and 29 Jul 2009.	0.00% 0/511 • 12 months ITT Population, Only Immediately Reportable Events (SAEs or withdrawal due to AEs) collected for this study. Data collected between 9 Aug 2007 and 29 Jul 2009.
Nervous system disorders Transient Ischaemic Attack	0.20% 1/512 • 12 months ITT Population, Only Immediately Reportable Events (SAEs or withdrawal due to AEs) collected for this study. Data collected between 9 Aug 2007 and 29 Jul 2009.	0.00% 0/511 • 12 months ITT Population, Only Immediately Reportable Events (SAEs or withdrawal due to AEs) collected for this study. Data collected between 9 Aug 2007 and 29 Jul 2009.
General disorders Chest Pain	0.20% 1/512 • 12 months ITT Population, Only Immediately Reportable Events (SAEs or withdrawal due to AEs) collected for this study. Data collected between 9 Aug 2007 and 29 Jul 2009.	0.00% 0/511 • 12 months ITT Population, Only Immediately Reportable Events (SAEs or withdrawal due to AEs) collected for this study. Data collected between 9 Aug 2007 and 29 Jul 2009.