Trial Outcomes & Findings for Anti-HIV Drug Regimens and Treatment-Switching Guidelines in HIV Infected Children (NCT NCT00039741)

NCT ID: NCT00039741

Last Updated: 2021-11-05

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE2/PHASE3
• Target enrollment: 266 participants
• Primary outcome timeframe: Baseline visit and 4 years after Study Entry
• Results posted on: 2021-11-05

Participant Flow

Recruited at Pediatric AIDS Clinical Trials Group (PACTG) units in the U.S. and Puerto Rico, and Paediatric European Network for Treatment of AIDS (PENTA) units in Argentina, Austria, the Bahamas, Brazil, France, Germany, Italy, Romania, Spain, the United Kingdom and Ireland. Enrollment started 9/25/02 and ended 9/7/05.

Participants were stratified by age (<3 years versus 3+ years), origin (PACTG site or PENTA site), and exposure versus no exposure to antiretroviral therapy perinatally. 266 children were randomized, of whom 3 are excluded from all analyses (2 had consent withdrawn by parents after randomization, 1 was ineligible).

Participant milestones

Measure	PI/1K Two nucleoside reverse transcriptase inhibitors (NRTI) plus a protease inhibitor (PI)with a regimen change recommended when viral load is 1000 copies/ml or higher	NNRTI/1K 2 NRTIs plus a nonnucleoside reverse transcriptase inhibitor (NNRTI) with a regimen change recommended when viral load reaches 1,000 copies/ml or higher	PI/30K Two NRTIs plus a PIwith a regimen change recommended when viral load is 30,000 copies/ml or higher	NNRTI/30K 2 NRTIs plus an NNRTI with a regimen change recommended when viral load reaches 30,000 copies/ml or higher
Overall Study STARTED	66	68	65	64
Overall Study Death	0	1	0	0
Overall Study COMPLETED	51	56	54	50
Overall Study NOT COMPLETED	15	12	11	14

Reasons for withdrawal

Measure	PI/1K Two nucleoside reverse transcriptase inhibitors (NRTI) plus a protease inhibitor (PI)with a regimen change recommended when viral load is 1000 copies/ml or higher	NNRTI/1K 2 NRTIs plus a nonnucleoside reverse transcriptase inhibitor (NNRTI) with a regimen change recommended when viral load reaches 1,000 copies/ml or higher	PI/30K Two NRTIs plus a PIwith a regimen change recommended when viral load is 30,000 copies/ml or higher	NNRTI/30K 2 NRTIs plus an NNRTI with a regimen change recommended when viral load reaches 30,000 copies/ml or higher
Overall Study Death	0	1	0	0
Overall Study Lost to Follow-up	3	1	5	2
Overall Study Confounding medical condition	1	0	0	0
Overall Study Not able to get to clinic	5	2	0	3
Overall Study Moved	3	2	3	6
Overall Study Non-compliance with protocol	1	0	1	0
Overall Study Withdrew consent	0	5	0	1
Overall Study Missed final visit	2	1	2	2

Baseline Characteristics

Anti-HIV Drug Regimens and Treatment-Switching Guidelines in HIV Infected Children

Baseline characteristics by cohort

Measure	PI/1K n=66 Participants Two nucleoside reverse transcriptase inhibitors (NRTI) plus a protease inhibitor (PI)with a regimen change recommended when viral load is 1000 copies/ml or higher	NNRTI/1K n=68 Participants 2 NRTIs plus a nonnucleoside reverse transcriptase inhibitor (NNRTI) with a regimen change recommended when viral load reaches 1,000 copies/ml or higher	PI/30K n=65 Participants Two NRTIs plus a PIwith a regimen change recommended when viral load is 30,000 copies/ml or higher	NNRTI/30K n=64 Participants 2 NRTIs plus an NNRTI with a regimen change recommended when viral load reaches 30,000 copies/ml or higher	Total n=263 Participants Total of all reporting groups
Age, Continuous	8.0 years STANDARD_DEVIATION 5.7 • n=5 Participants	7.0 years STANDARD_DEVIATION 5.4 • n=7 Participants	7.9 years STANDARD_DEVIATION 5.4 • n=5 Participants	6.9 years STANDARD_DEVIATION 5.0 • n=4 Participants	7.5 years STANDARD_DEVIATION 5.4 • n=21 Participants
Age, Customized >30 days to <=12 months	10 participants n=5 Participants	12 participants n=7 Participants	7 participants n=5 Participants	11 participants n=4 Participants	40 participants n=21 Participants
Age, Customized >12 months to <=3 years	8 participants n=5 Participants	7 participants n=7 Participants	8 participants n=5 Participants	5 participants n=4 Participants	28 participants n=21 Participants
Age, Customized >3 to <=9 years	19 participants n=5 Participants	27 participants n=7 Participants	24 participants n=5 Participants	29 participants n=4 Participants	99 participants n=21 Participants
Age, Customized >9 to <=14 years	14 participants n=5 Participants	13 participants n=7 Participants	13 participants n=5 Participants	10 participants n=4 Participants	50 participants n=21 Participants
Age, Customized >14 years to <18 years	15 participants n=5 Participants	9 participants n=7 Participants	13 participants n=5 Participants	9 participants n=4 Participants	46 participants n=21 Participants
Sex: Female, Male Female	30 Participants n=5 Participants	33 Participants n=7 Participants	32 Participants n=5 Participants	32 Participants n=4 Participants	127 Participants n=21 Participants
Sex: Female, Male Male	36 Participants n=5 Participants	35 Participants n=7 Participants	33 Participants n=5 Participants	32 Participants n=4 Participants	136 Participants n=21 Participants
Region of Enrollment United States	18 participants n=5 Participants	20 participants n=7 Participants	16 participants n=5 Participants	18 participants n=4 Participants	72 participants n=21 Participants
Region of Enrollment Puerto Rico	1 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants	0 participants n=4 Participants	3 participants n=21 Participants
Region of Enrollment Argentina	1 participants n=5 Participants	4 participants n=7 Participants	3 participants n=5 Participants	3 participants n=4 Participants	11 participants n=21 Participants
Region of Enrollment Austria	1 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	1 participants n=4 Participants	2 participants n=21 Participants
Region of Enrollment Bahamas	2 participants n=5 Participants	0 participants n=7 Participants	2 participants n=5 Participants	0 participants n=4 Participants	4 participants n=21 Participants
Region of Enrollment Brazil	12 participants n=5 Participants	11 participants n=7 Participants	9 participants n=5 Participants	9 participants n=4 Participants	41 participants n=21 Participants
Region of Enrollment France	3 participants n=5 Participants	3 participants n=7 Participants	5 participants n=5 Participants	6 participants n=4 Participants	17 participants n=21 Participants
Region of Enrollment Germany	5 participants n=5 Participants	6 participants n=7 Participants	3 participants n=5 Participants	7 participants n=4 Participants	21 participants n=21 Participants
Region of Enrollment Italy	7 participants n=5 Participants	4 participants n=7 Participants	5 participants n=5 Participants	6 participants n=4 Participants	22 participants n=21 Participants
Region of Enrollment Romania	8 participants n=5 Participants	7 participants n=7 Participants	9 participants n=5 Participants	7 participants n=4 Participants	31 participants n=21 Participants
Region of Enrollment Spain	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants	0 participants n=4 Participants	2 participants n=21 Participants
Region of Enrollment United Kingdom	7 participants n=5 Participants	11 participants n=7 Participants	9 participants n=5 Participants	6 participants n=4 Participants	33 participants n=21 Participants
Region of Enrollment Ireland	0 participants n=5 Participants	1 participants n=7 Participants	2 participants n=5 Participants	1 participants n=4 Participants	4 participants n=21 Participants
Viral Load	5.2 Log10 copies/ml STANDARD_DEVIATION 0.8 • n=5 Participants	5.0 Log10 copies/ml STANDARD_DEVIATION 0.8 • n=7 Participants	5.0 Log10 copies/ml STANDARD_DEVIATION 0.8 • n=5 Participants	5.1 Log10 copies/ml STANDARD_DEVIATION 0.8 • n=4 Participants	5.1 Log10 copies/ml STANDARD_DEVIATION 0.8 • n=21 Participants
PENTA/PACTG site PENTA	47 participants n=5 Participants	47 participants n=7 Participants	48 participants n=5 Participants	46 participants n=4 Participants	188 participants n=21 Participants
PENTA/PACTG site PACTG	19 participants n=5 Participants	21 participants n=7 Participants	17 participants n=5 Participants	18 participants n=4 Participants	75 participants n=21 Participants
CD4 percent (percentage of total lymphocytes that are CD4 cells)	18 CD4% STANDARD_DEVIATION 12 • n=5 Participants	18 CD4% STANDARD_DEVIATION 10 • n=7 Participants	18 CD4% STANDARD_DEVIATION 11 • n=5 Participants	17 CD4% STANDARD_DEVIATION 12 • n=4 Participants	18 CD4% STANDARD_DEVIATION 11 • n=21 Participants

PRIMARY outcome

Timeframe: Baseline visit and 4 years after Study Entry

Population: Intent-to-treat analyses for those subjects who had data at baseline and 4 years. Analyses were done by collapsing groups to examine drug class (regardless of switch point) and switch point (regardless of drug class).

Outcome measures

Measure	Drug Class/PI n=118 Participants Participants randomized to receive a PI-based regimen, regardless of switch point.	Drug Class/NNRTI n=116 Participants Participants randomized to receive an NNRTI-based regimen, regardless of switch point.	Switch Point (1K) n=117 Participants Participants randomized to switch to second-line therapy when HIV-1 RNA is \>=1,000 copies/mL, regardless of drug class.	Switch Point (30K) n=117 Participants Participants randomized to switch to second-line therapy when HIV-1 RNA is \>=30,000 copies/mL, regardless of drug class.
Change in Viral Load Measured in log10 HIV-1 RNA Copies/ml	-3.16 log10 HIV-1 RNA Standard Error 0.09	-3.31 log10 HIV-1 RNA Standard Error 0.09	-3.26 log10 HIV-1 RNA Standard Error 0.09	-3.20 log10 HIV-1 RNA Standard Error 0.09

SECONDARY outcome

Timeframe: Up to 6 yrs. (average 4.85 yrs.)

Population: Intent to treat

Adverse events were graded according to the following guidelines:

PACTG: "The Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual) dated May 6, 2004.

PENTA: International Conference for Harmonization (ICH) requirements and the EU Clinical Trials Directive 2001/20/EC (20).

A rating of Grade 3 is severe and Grade 4 is life-threatening. The rate of serious (Grade 3 or above)events is reported as the number of events per 100 child/years.

Outcome measures

Measure	Drug Class/PI n=131 Participants Participants randomized to receive a PI-based regimen, regardless of switch point.	Drug Class/NNRTI n=132 Participants Participants randomized to receive an NNRTI-based regimen, regardless of switch point.	Switch Point (1K) n=134 Participants Participants randomized to switch to second-line therapy when HIV-1 RNA is \>=1,000 copies/mL, regardless of drug class.	Switch Point (30K) n=129 Participants Participants randomized to switch to second-line therapy when HIV-1 RNA is \>=30,000 copies/mL, regardless of drug class.
Rate of Grade 3 or Higher Signs, Symptoms, or Laboratory Abnormalities Experienced	0.16 events/100 child-years Interval 0.08 to 0.31	0.17 events/100 child-years Interval 0.09 to 0.31	0.16 events/100 child-years Interval 0.08 to 0.31	0.17 events/100 child-years Interval 0.09 to 0.31

SECONDARY outcome

Timeframe: Up to 6 yrs. (average 4.85 yrs.)

Population: Intent to treat

Outcome measures

Measure	Drug Class/PI n=131 Participants Participants randomized to receive a PI-based regimen, regardless of switch point.	Drug Class/NNRTI n=132 Participants Participants randomized to receive an NNRTI-based regimen, regardless of switch point.	Switch Point (1K) n=134 Participants Participants randomized to switch to second-line therapy when HIV-1 RNA is \>=1,000 copies/mL, regardless of drug class.	Switch Point (30K) n=129 Participants Participants randomized to switch to second-line therapy when HIV-1 RNA is \>=30,000 copies/mL, regardless of drug class.
Participants With Significant HIV-related Clinical Events, Defined as CDC Category C (AIDS Defining) Diagnoses (Except for Recurrent Bacterial Infections)or Death	6 participants	4 participants	5 participants	5 participants

SECONDARY outcome

Timeframe: Up to 6 yrs. (average 4.85 yrs.)

Population: Intent to treat

25th Percentiles in weeks from randomization to starting an alternative class ART regimen (based on initial randomized regimen)

Outcome measures

Measure	Drug Class/PI n=131 Participants Participants randomized to receive a PI-based regimen, regardless of switch point.	Drug Class/NNRTI n=132 Participants Participants randomized to receive an NNRTI-based regimen, regardless of switch point.	Switch Point (1K) n=134 Participants Participants randomized to switch to second-line therapy when HIV-1 RNA is \>=1,000 copies/mL, regardless of drug class.	Switch Point (30K) n=129 Participants Participants randomized to switch to second-line therapy when HIV-1 RNA is \>=30,000 copies/mL, regardless of drug class.
Time to Switching to an Alternative Class ART Regimen (Based on Initial Randomized Regimen)	NA Weeks (25th Percentile) Interval 295.0 to Fewer than 50% of participants reached the switching criteria, so the median and 75th percentile are undefined.	NA Weeks (25th Percentile) Interval 142.0 to Fewer than 50% of participants reached the switching criteria, so the median and 75th percentile are undefined.	NA Weeks (25th Percentile) Interval 142.0 to Fewer than 50% of participants reached the switching criteria, so the median and 75th percentile are undefined.	NA Weeks (25th Percentile) Interval 240.0 to Fewer than 50% of participants reached the switching criteria, so the median and 75th percentile are undefined.

SECONDARY outcome

Timeframe: Up to 6 yrs. (average 4.85 yrs.)

Population: Intent to treat

25th Percentiles in weeks from randomization HIV-1 RNA of 400 copies/ml or greater during first-line therapy or permanent discontinuation of first-line therapy.

Outcome measures

Measure	Drug Class/PI n=131 Participants Participants randomized to receive a PI-based regimen, regardless of switch point.	Drug Class/NNRTI n=132 Participants Participants randomized to receive an NNRTI-based regimen, regardless of switch point.	Switch Point (1K) n=134 Participants Participants randomized to switch to second-line therapy when HIV-1 RNA is \>=1,000 copies/mL, regardless of drug class.	Switch Point (30K) n=129 Participants Participants randomized to switch to second-line therapy when HIV-1 RNA is \>=30,000 copies/mL, regardless of drug class.
Time to HIV-1 RNA of 400 Copies/ml or Greater During First-line Therapy or Permanent Discontinuation of First-line Therapy	36 Weeks (25th Percentile)	68 Weeks (25th Percentile)	41 Weeks (25th Percentile)	72 Weeks (25th Percentile)

SECONDARY outcome

Timeframe: Up to 6 yrs. (average 4.85 yrs.)

Population: Intent to treat

25th Percentiles in weeks from randomization to HIV-1 RNA of 30,000 copies/ml or greater during second-line therapy or permanent discontinuation of second-line therapy

Outcome measures

Measure	Drug Class/PI n=28 Participants Participants randomized to receive a PI-based regimen, regardless of switch point.	Drug Class/NNRTI n=32 Participants Participants randomized to receive an NNRTI-based regimen, regardless of switch point.	Switch Point (1K) n=37 Participants Participants randomized to switch to second-line therapy when HIV-1 RNA is \>=1,000 copies/mL, regardless of drug class.	Switch Point (30K) n=23 Participants Participants randomized to switch to second-line therapy when HIV-1 RNA is \>=30,000 copies/mL, regardless of drug class.
Time to HIV-1 RNA of 30,000 Copies/ml or Greater During Second-line Therapy or Permanent Discontinuation of Second-line Therapy	126 Weeks (25th Percentile)	267 Weeks (25th Percentile)	267 Weeks (25th Percentile)	228 Weeks (25th Percentile)

SECONDARY outcome

Timeframe: Week 204

Population: Intent to treat. Numbers are reported among participants who had an HIV-1 RNA value and were in follow-up at week 204.

Outcome measures

Measure	Drug Class/PI n=112 Participants Participants randomized to receive a PI-based regimen, regardless of switch point.	Drug Class/NNRTI n=114 Participants Participants randomized to receive an NNRTI-based regimen, regardless of switch point.	Switch Point (1K) n=114 Participants Participants randomized to switch to second-line therapy when HIV-1 RNA is \>=1,000 copies/mL, regardless of drug class.	Switch Point (30K) n=112 Participants Participants randomized to switch to second-line therapy when HIV-1 RNA is \>=30,000 copies/mL, regardless of drug class.
Number of Children With an HIV-1 RNA Level Less Than 400 Copies/ml Regardless of Therapy at Week 204	92 participants	93 participants	95 participants	90 participants

SECONDARY outcome

Timeframe: Randomization to 4 years

Population: Intent to treat, for participants who had CD4% values available at 4 years and at baseline.

Outcome measures

Measure	Drug Class/PI n=131 Participants Participants randomized to receive a PI-based regimen, regardless of switch point.	Drug Class/NNRTI n=132 Participants Participants randomized to receive an NNRTI-based regimen, regardless of switch point.	Switch Point (1K) n=134 Participants Participants randomized to switch to second-line therapy when HIV-1 RNA is \>=1,000 copies/mL, regardless of drug class.	Switch Point (30K) n=129 Participants Participants randomized to switch to second-line therapy when HIV-1 RNA is \>=30,000 copies/mL, regardless of drug class.
Change in CD4% From Randomization to 4 Years	13.7 CD4 percent (% of total lymphocytes) Standard Deviation 0.8	15.2 CD4 percent (% of total lymphocytes) Standard Deviation 0.8	15.1 CD4 percent (% of total lymphocytes) Standard Deviation 0.8	13.9 CD4 percent (% of total lymphocytes) Standard Deviation 0.8

SECONDARY outcome

Timeframe: 24 weeks

Population: Intent to treat - numbers are reported among participants who had an HIV-1 RNA value and were in follow-up at week 24.

Outcome measures

Measure	Drug Class/PI n=130 Participants Participants randomized to receive a PI-based regimen, regardless of switch point.	Drug Class/NNRTI n=129 Participants Participants randomized to receive an NNRTI-based regimen, regardless of switch point.	Switch Point (1K) n=132 Participants Participants randomized to switch to second-line therapy when HIV-1 RNA is \>=1,000 copies/mL, regardless of drug class.	Switch Point (30K) n=127 Participants Participants randomized to switch to second-line therapy when HIV-1 RNA is \>=30,000 copies/mL, regardless of drug class.
Number of Children With HIV-1 RNA Less Than 400 Copies/ml and on Original Randomized Therapy at 24 Weeks	92 participants	98 participants	99 participants	91 participants

Adverse Events

PI/1K

Serious events: 9 serious events

Other events: 0 other events

Deaths: 0 deaths

NNRTI/1K

Serious events: 10 serious events

Other events: 0 other events

Deaths: 0 deaths

PI/30K

Serious events: 14 serious events

Other events: 0 other events

Deaths: 0 deaths

NNRTI/30K

Serious events: 15 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	PI/1K n=66 participants at risk Two nucleoside reverse transcriptase inhibitors (NRTI) plus a protease inhibitor (PI)with a regimen change recommended when viral load is 1000 copies/ml or higher	NNRTI/1K n=68 participants at risk 2 NRTIs plus a nonnucleoside reverse transcriptase inhibitor (NNRTI) with a regimen change recommended when viral load reaches 1,000 copies/ml or higher	PI/30K n=65 participants at risk Two NRTIs plus a PIwith a regimen change recommended when viral load is 30,000 copies/ml or higher	NNRTI/30K n=64 participants at risk 2 NRTIs plus an NNRTI with a regimen change recommended when viral load reaches 30,000 copies/ml or higher
Blood and lymphatic system disorders Anemia	1.5% 1/66 • Number of events 1 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	0.00% 0/68 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	0.00% 0/65 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	1.6% 1/64 • Number of events 1 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.
Blood and lymphatic system disorders Anemia megaloblastic	0.00% 0/66 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	0.00% 0/68 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	1.5% 1/65 • Number of events 1 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	0.00% 0/64 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.
Blood and lymphatic system disorders Aplastic anemia	0.00% 0/66 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	0.00% 0/68 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	0.00% 0/65 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	1.6% 1/64 • Number of events 1 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.
Blood and lymphatic system disorders Lymphadenitis	0.00% 0/66 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	0.00% 0/68 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	0.00% 0/65 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	1.6% 1/64 • Number of events 1 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/66 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	0.00% 0/68 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	1.5% 1/65 • Number of events 1 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	0.00% 0/64 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.
Ear and labyrinth disorders Vertigo	1.5% 1/66 • Number of events 1 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	0.00% 0/68 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	0.00% 0/65 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	0.00% 0/64 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.
Eye disorders Retinal detachment	0.00% 0/66 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	0.00% 0/68 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	0.00% 0/65 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	1.6% 1/64 • Number of events 1 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.
Eye disorders Uveitis	0.00% 0/66 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	0.00% 0/68 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	0.00% 0/65 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	1.6% 1/64 • Number of events 1 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.
Eye disorders Progressive external ophthalmoplegia	0.00% 0/66 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	0.00% 0/68 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	0.00% 0/65 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	1.6% 1/64 • Number of events 1 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.
Gastrointestinal disorders Abdominal pain	1.5% 1/66 • Number of events 1 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	0.00% 0/68 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	0.00% 0/65 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	1.6% 1/64 • Number of events 1 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.
Gastrointestinal disorders Constipation	0.00% 0/66 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	1.5% 1/68 • Number of events 1 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	0.00% 0/65 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	0.00% 0/64 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.
Gastrointestinal disorders Diarrhea	0.00% 0/66 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	0.00% 0/68 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	1.5% 1/65 • Number of events 1 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	1.6% 1/64 • Number of events 1 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.
Gastrointestinal disorders Diarrhea, viral	0.00% 0/66 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	0.00% 0/68 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	0.00% 0/65 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	1.6% 1/64 • Number of events 1 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.
Gastrointestinal disorders Food poisoning	0.00% 0/66 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	0.00% 0/68 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	0.00% 0/65 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	1.6% 1/64 • Number of events 1 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.
Gastrointestinal disorders Gastointestinal disorder	0.00% 0/66 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	0.00% 0/68 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	1.5% 1/65 • Number of events 1 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	0.00% 0/64 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.
Gastrointestinal disorders Pancreatitis	1.5% 1/66 • Number of events 1 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	0.00% 0/68 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	0.00% 0/65 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	0.00% 0/64 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.
Gastrointestinal disorders Vomiting	1.5% 1/66 • Number of events 1 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	0.00% 0/68 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	1.5% 1/65 • Number of events 1 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	3.1% 2/64 • Number of events 2 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.
General disorders Drug intolerance	0.00% 0/66 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	0.00% 0/68 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	0.00% 0/65 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	1.6% 1/64 • Number of events 1 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.
General disorders Pyrexia	0.00% 0/66 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	1.5% 1/68 • Number of events 1 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	0.00% 0/65 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	0.00% 0/64 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.
General disorders Systemic inflammatory response syndrome	0.00% 0/66 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	0.00% 0/68 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	1.5% 1/65 • Number of events 1 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	0.00% 0/64 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.
Hepatobiliary disorders Biliary dyskinesia	0.00% 0/66 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	0.00% 0/68 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	0.00% 0/65 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	1.6% 1/64 • Number of events 1 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.
Immune system disorders Drug hypersensitivity	0.00% 0/66 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	0.00% 0/68 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	1.5% 1/65 • Number of events 1 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	0.00% 0/64 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.
Immune system disorders Erythema nodosum	0.00% 0/66 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	0.00% 0/68 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	0.00% 0/65 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	1.6% 1/64 • Number of events 1 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.
Immune system disorders Hypersensitivity	1.5% 1/66 • Number of events 1 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	0.00% 0/68 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	1.5% 1/65 • Number of events 1 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	0.00% 0/64 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.
Infections and infestations Appendicitis, perforated	0.00% 0/66 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	1.5% 1/68 • Number of events 1 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	0.00% 0/65 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	0.00% 0/64 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.
Infections and infestations Arthritis, viral	0.00% 0/66 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	0.00% 0/68 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	0.00% 0/65 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	1.6% 1/64 • Number of events 1 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.
Infections and infestations Bacterial pyelonephritis	0.00% 0/66 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	1.5% 1/68 • Number of events 1 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	0.00% 0/65 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	0.00% 0/64 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.
Infections and infestations Dengue fever	0.00% 0/66 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	0.00% 0/68 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	1.5% 1/65 • Number of events 1 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	1.6% 1/64 • Number of events 1 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.
Infections and infestations Escherichia	0.00% 0/66 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	0.00% 0/68 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	1.5% 1/65 • Number of events 1 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	0.00% 0/64 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.
Infections and infestations Gastroenteritis rotavirus	1.5% 1/66 • Number of events 1 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	0.00% 0/68 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	0.00% 0/65 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	0.00% 0/64 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.
Infections and infestations Implant site cellulitis	0.00% 0/66 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	0.00% 0/68 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	0.00% 0/65 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	1.6% 1/64 • Number of events 1 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.
Infections and infestations Laryngitis, viral	1.5% 1/66 • Number of events 1 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	0.00% 0/68 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	0.00% 0/65 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	0.00% 0/64 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.
Infections and infestations Mastoiditis	0.00% 0/66 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	0.00% 0/68 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	1.5% 1/65 • Number of events 1 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	0.00% 0/64 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.
Infections and infestations Esophageal candidiasis	0.00% 0/66 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	0.00% 0/68 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	1.5% 1/65 • Number of events 1 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	0.00% 0/64 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.
Infections and infestations Pelvic inflammatory disease	1.5% 1/66 • Number of events 1 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	0.00% 0/68 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	0.00% 0/65 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	0.00% 0/64 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.
Infections and infestations Pneumonia	0.00% 0/66 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	1.5% 1/68 • Number of events 1 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	0.00% 0/65 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	1.6% 1/64 • Number of events 1 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.
Infections and infestations Respiratory syncytial virus bronchiolitis	0.00% 0/66 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	0.00% 0/68 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	1.5% 1/65 • Number of events 1 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	0.00% 0/64 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.
Infections and infestations Tonsilitis	0.00% 0/66 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	0.00% 0/68 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	0.00% 0/65 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	1.6% 1/64 • Number of events 1 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.
Infections and infestations Urinary tract infection	1.5% 1/66 • Number of events 1 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	0.00% 0/68 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	1.5% 1/65 • Number of events 1 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	3.1% 2/64 • Number of events 2 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.
Injury, poisoning and procedural complications Concussion	0.00% 0/66 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	0.00% 0/68 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	1.5% 1/65 • Number of events 1 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	0.00% 0/64 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.
Injury, poisoning and procedural complications Joint sprain	0.00% 0/66 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	0.00% 0/68 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	0.00% 0/65 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	1.6% 1/64 • Number of events 1 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.
Investigations Alanine aminotransferase increased	1.5% 1/66 • Number of events 1 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	1.5% 1/68 • Number of events 1 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	1.5% 1/65 • Number of events 1 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	0.00% 0/64 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.
Investigations Aspartate aminotransferase increased	1.5% 1/66 • Number of events 1 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	0.00% 0/68 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	1.5% 1/65 • Number of events 1 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	0.00% 0/64 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.
Investigations Blood creatine phosphkinase increased	0.00% 0/66 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	0.00% 0/68 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	1.5% 1/65 • Number of events 1 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	0.00% 0/64 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.
Musculoskeletal and connective tissue disorders Myopathy	0.00% 0/66 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	0.00% 0/68 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	0.00% 0/65 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	1.6% 1/64 • Number of events 1 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.
Musculoskeletal and connective tissue disorders Myositis	0.00% 0/66 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	0.00% 0/68 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	1.5% 1/65 • Number of events 1 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	0.00% 0/64 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.
Nervous system disorders Epilepsy	0.00% 0/66 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	1.5% 1/68 • Number of events 1 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	0.00% 0/65 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	0.00% 0/64 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.
Nervous system disorders Hypotonia	0.00% 0/66 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	1.5% 1/68 • Number of events 1 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	0.00% 0/65 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	0.00% 0/64 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.
Nervous system disorders Myasthenia gravis	0.00% 0/66 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	1.5% 1/68 • Number of events 1 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	0.00% 0/65 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	0.00% 0/64 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.
Pregnancy, puerperium and perinatal conditions Pre-eclampsia	1.5% 1/66 • Number of events 1 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	0.00% 0/68 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	0.00% 0/65 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	0.00% 0/64 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.
Psychiatric disorders Generalized anxiety disorder	0.00% 0/66 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	0.00% 0/68 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	0.00% 0/65 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	1.6% 1/64 • Number of events 1 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.
Psychiatric disorders Major depression	0.00% 0/66 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	1.5% 1/68 • Number of events 1 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	0.00% 0/65 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	0.00% 0/64 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.
Psychiatric disorders Panic disorder	0.00% 0/66 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	0.00% 0/68 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	0.00% 0/65 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	1.6% 1/64 • Number of events 1 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.
Psychiatric disorders Psychotic disorder	0.00% 0/66 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	0.00% 0/68 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	0.00% 0/65 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	1.6% 1/64 • Number of events 1 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.
Psychiatric disorders Schizophrenia	0.00% 0/66 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	0.00% 0/68 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	0.00% 0/65 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	1.6% 1/64 • Number of events 1 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.
Psychiatric disorders Suicide attempt	0.00% 0/66 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	1.5% 1/68 • Number of events 1 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	0.00% 0/65 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	0.00% 0/64 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.
Renal and urinary disorders Acute renal failure	0.00% 0/66 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	0.00% 0/68 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	1.5% 1/65 • Number of events 1 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	0.00% 0/64 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.
Reproductive system and breast disorders Ovarian cyst	0.00% 0/66 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	0.00% 0/68 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	1.5% 1/65 • Number of events 1 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	0.00% 0/64 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.
Respiratory, thoracic and mediastinal disorders Acute sinusitis	0.00% 0/66 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	0.00% 0/68 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	1.5% 1/65 • Number of events 1 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	0.00% 0/64 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.
Respiratory, thoracic and mediastinal disorders Bronchial hyperreactivity	0.00% 0/66 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	0.00% 0/68 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	0.00% 0/65 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	1.6% 1/64 • Number of events 1 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.
Respiratory, thoracic and mediastinal disorders Croup, infectious	0.00% 0/66 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	0.00% 0/68 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	1.5% 1/65 • Number of events 1 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	0.00% 0/64 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.00% 0/66 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	2.9% 2/68 • Number of events 2 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	0.00% 0/65 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	0.00% 0/64 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.
Skin and subcutaneous tissue disorders Drug eruption	0.00% 0/66 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	0.00% 0/68 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	0.00% 0/65 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	1.6% 1/64 • Number of events 1 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.
Skin and subcutaneous tissue disorders Rash, maculo-papular	0.00% 0/66 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	1.5% 1/68 • Number of events 1 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	0.00% 0/65 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	1.6% 1/64 • Number of events 1 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.
Vascular disorders Vasculitis	0.00% 0/66 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	0.00% 0/68 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	0.00% 0/65 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.	1.6% 1/64 • Number of events 1 • Participants were followed for up to 6.8 years, with a median of 5 years. The last study visit was August 31, 2009. ICH (International Conference for Harmonization) criteria were used for determining Serious Adverse Events. Only events with Grade 3 or greater are reported. No Other (Non-Serious) Adverse events occurred with 5% or greater frequency.

Other adverse events

Adverse event data not reported

Additional Information

Melissa Allen, Director, IMPAACT Operations Center

Family Health International (FHI 360)

Phone: (919) 405-1429

Email: mallen@fhi360.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place