Trial Outcomes & Findings for ELND005 Long-Term Follow-up Study in Subjects With Alzheimer's Disease (NCT NCT00934050)

NCT ID: NCT00934050

Last Updated: 2019-10-21

Results Overview

Safety and Tolerability was assessed by the incidence of Treatment Emergent Adverse Events (TEAEs)

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 103 participants
• Primary outcome timeframe: 12 months
• Results posted on: 2019-10-21

Participant Flow

All participants who enrolled in long term follow up prior to 15 Dec 2009 received ELND005 2000 mg BID; due to protocol amendment, all participants who enrolled in long term follow up after 15 Dec 2009 received ELND005 250 mg BID

Participant milestones

Measure	Placebo/ELND005 2000mg BID In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive Placebo for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up prior to 15 Dec 2009 were assigned to receive ELND005 2000 mg PO BID for 48 weeks.	250mg/ELND005 2000mg BID In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive ELND005 250 mgPO BID for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up prior to 15 Dec 2009 were assigned to receive ELND005 2000 mg PO BID for 48 weeks.	1000 mg/ELND005 2000 mg BID In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive ELND005 1000 mg PO BID for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up prior to 15 Dec 2009 were assigned to receive ELND005 2000 mg PO BID for 48 weeks.	2000 mg ELND005/ELND005 2000 mg BID In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive ELND005 2000 mg PO BID for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up prior to 15 Dec 2009 were assigned to receive ELND005 2000 mg PO BID for 48 weeks.	Placebo/ELND005 250 mg BID In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive Placebo for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up after 15 Dec 2009 were assigned to receive ELND005 250 mg PO BID for 48 weeks.	250 mg/ELND005 250 mg BID In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive ELND005 250 mg PO BID for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up after 15 Dec 2009 were assigned to receive ELND005 250 mg PO BID for 48 weeks.
Enrolled Prior to 15 Dec 2009 STARTED	12	12	12	14	0	0
Enrolled Prior to 15 Dec 2009 COMPLETED	0	0	0	0	0	0
Enrolled Prior to 15 Dec 2009 NOT COMPLETED	12	12	12	14	0	0
Enrolled After 15 Dec 2009 STARTED	0	0	0	0	26	27
Enrolled After 15 Dec 2009 COMPLETED	0	0	0	0	19	23
Enrolled After 15 Dec 2009 NOT COMPLETED	0	0	0	0	7	4

Reasons for withdrawal

Measure	Placebo/ELND005 2000mg BID In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive Placebo for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up prior to 15 Dec 2009 were assigned to receive ELND005 2000 mg PO BID for 48 weeks.	250mg/ELND005 2000mg BID In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive ELND005 250 mgPO BID for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up prior to 15 Dec 2009 were assigned to receive ELND005 2000 mg PO BID for 48 weeks.	1000 mg/ELND005 2000 mg BID In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive ELND005 1000 mg PO BID for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up prior to 15 Dec 2009 were assigned to receive ELND005 2000 mg PO BID for 48 weeks.	2000 mg ELND005/ELND005 2000 mg BID In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive ELND005 2000 mg PO BID for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up prior to 15 Dec 2009 were assigned to receive ELND005 2000 mg PO BID for 48 weeks.	Placebo/ELND005 250 mg BID In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive Placebo for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up after 15 Dec 2009 were assigned to receive ELND005 250 mg PO BID for 48 weeks.	250 mg/ELND005 250 mg BID In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive ELND005 250 mg PO BID for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up after 15 Dec 2009 were assigned to receive ELND005 250 mg PO BID for 48 weeks.
Enrolled Prior to 15 Dec 2009 Adverse Event	1	0	0	1	0	0
Enrolled Prior to 15 Dec 2009 Sponsor Decision	11	12	11	13	0	0
Enrolled Prior to 15 Dec 2009 Withdrawal by Subject	0	0	1	0	0	0
Enrolled After 15 Dec 2009 Adverse Event	0	0	0	0	3	0
Enrolled After 15 Dec 2009 Death	0	0	0	0	0	1
Enrolled After 15 Dec 2009 Lost to Follow-up	0	0	0	0	0	1
Enrolled After 15 Dec 2009 Withdrawal by Subject	0	0	0	0	4	2

Baseline Characteristics

ELND005 Long-Term Follow-up Study in Subjects With Alzheimer's Disease

Baseline characteristics by cohort

Measure	Placebo/2000mg BID n=12 Participants In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive Placebo for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up prior to 15 Dec 2009 were assigned to receive ELND005 2000 mg PO BID for 48 weeks.	250mg BID/2000 mg BID n=12 Participants In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive ELND005 250 mg PO BID for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up prior to 15 Dec 2009 were assigned to receive ELND005 2000 mg PO BID for 48 weeks.	1000mg BID/2000mg BID n=12 Participants In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive ELND005 1000 mg PO BID for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up prior to 15 Dec 2009 were assigned to receive ELND005 2000 mg PO BID for 48 weeks.	2000mg BID/2000mg BID n=14 Participants In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive ELND05 2000 mg PO BID for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up prior to 15 Dec 2009 were assigned to receive ELND005 2000 mg PO BID for 48 weeks.	Placebo/ELND005 250mg BID n=26 Participants In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive Placebo for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up after 15 Dec 2009 were assigned to receive ELND005 250 mg PO BID for 48 weeks.	250 mg/ELND005 250 mg BID n=27 Participants In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive ELND005 250 mg PO BID for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up after 15 Dec 2009 were assigned to receive ELND005 250 mg PO BID for 48 weeks.	Total n=103 Participants Total of all reporting groups
Age, Continuous Enrolled prior to 15 Dec 2009	76.8 Years STANDARD_DEVIATION 5.51 • n=5 Participants	77.0 Years STANDARD_DEVIATION 6.98 • n=7 Participants	76.9 Years STANDARD_DEVIATION 6.92 • n=5 Participants	69.2 Years STANDARD_DEVIATION 8.51 • n=4 Participants	NA Years STANDARD_DEVIATION NA • n=21 Participants	NA Years STANDARD_DEVIATION NA • n=10 Participants	74.7 Years STANDARD_DEVIATION 7.73 • n=115 Participants
Age, Continuous Participants enrolled after 15 Dec 2009	NA Years STANDARD_DEVIATION NA • n=5 Participants	NA Years STANDARD_DEVIATION NA • n=7 Participants	NA Years STANDARD_DEVIATION NA • n=5 Participants	NA Years STANDARD_DEVIATION NA • n=4 Participants	71.4 Years STANDARD_DEVIATION 8.77 • n=21 Participants	73.0 Years STANDARD_DEVIATION 7.53 • n=10 Participants	72.2 Years STANDARD_DEVIATION 8.12 • n=115 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	5 Participants n=7 Participants	5 Participants n=5 Participants	7 Participants n=4 Participants	18 Participants n=21 Participants	19 Participants n=10 Participants	59 Participants n=115 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	7 Participants n=7 Participants	7 Participants n=5 Participants	7 Participants n=4 Participants	8 Participants n=21 Participants	8 Participants n=10 Participants	44 Participants n=115 Participants
Race/Ethnicity, Customized Hispanic or Latino	1 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	0 participants n=21 Participants	1 participants n=10 Participants	2 participants n=115 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	11 participants n=5 Participants	12 participants n=7 Participants	12 participants n=5 Participants	14 participants n=4 Participants	26 participants n=21 Participants	26 participants n=10 Participants	101 participants n=115 Participants
Region of Enrollment North America	12 participants n=5 Participants	12 participants n=7 Participants	12 participants n=5 Participants	14 participants n=4 Participants	26 participants n=21 Participants	27 participants n=10 Participants	103 participants n=115 Participants

PRIMARY outcome

Timeframe: 12 months

Population: As a result of safety findings, effective 15 December 2009, all 50 patients at the 2000 mg BID dose were withdrawn from the study. Subsequently patients who were on placebo or 250 mg BID in Study AD201 received 250 mg BID in Study AD251. Only Arms who completed the study per the protocol were included in the analysis.

Safety and Tolerability was assessed by the incidence of Treatment Emergent Adverse Events (TEAEs)

Outcome measures

Measure	Placebo/ELND005 250mg BID n=26 Participants In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive Placebo for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up after 15 Dec 2009 were assigned to receive ELND005 250 mg PO BID for 48 weeks.	250 mg/ELND005 250 mg BID n=27 Participants In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive ELND005 250 mg PO BID for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up after 15 Dec 2009 were assigned to receive ELND005 250 mg PO BID for 48 weeks.
Treatment Emergent Adverse Events (TEAEs)	21 participants	23 participants

Adverse Events

Placebo/ELND005 2000mg BID

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

250mg/ELND005 2000mg BID

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

1000 mg/ELND005 2000 mg BID

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

2000 mg ELND005/ELND005 2000 mg BID

Serious events: 2 serious events

Other events: 3 other events

Deaths: 0 deaths

Placebo/ELND005 250 mg BID

Serious events: 5 serious events

Other events: 11 other events

Deaths: 0 deaths

250 mg/ELND005 250 mg BID

Serious events: 6 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Measure	Placebo/ELND005 2000mg BID n=12 participants at risk In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive Placebo for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up prior to 15 Dec 2009 were assigned to receive ELND005 2000 mg PO BID for 48 weeks.	250mg/ELND005 2000mg BID n=12 participants at risk In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive ELND005 250 mgPO BID for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up prior to 15 Dec 2009 were assigned to receive ELND005 2000 mg PO BID for 48 weeks.	1000 mg/ELND005 2000 mg BID n=12 participants at risk In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive ELND005 1000 mg PO BID for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up prior to 15 Dec 2009 were assigned to receive ELND005 2000 mg PO BID for 48 weeks.	2000 mg ELND005/ELND005 2000 mg BID n=14 participants at risk In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive ELND005 2000 mg PO BID for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up prior to 15 Dec 2009 were assigned to receive ELND005 2000 mg PO BID for 48 weeks.	Placebo/ELND005 250 mg BID n=26 participants at risk In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive Placebo for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up after 15 Dec 2009 were assigned to receive ELND005 250 mg PO BID for 48 weeks.	250 mg/ELND005 250 mg BID n=27 participants at risk In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive ELND005 250 mg PO BID for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up after 15 Dec 2009 were assigned to receive ELND005 250 mg PO BID for 48 weeks.
Cardiac disorders Atrial Fibrillation	0.00% 0/12 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/12 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/12 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	7.1% 1/14 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/26 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/27 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.
Cardiac disorders Cardiac Failure Congestive	0.00% 0/12 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/12 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/12 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	7.1% 1/14 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/26 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/27 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.
Cardiac disorders Bradycardia	0.00% 0/12 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/12 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/12 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/14 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	3.8% 1/26 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/27 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.
Infections and infestations Klebsiella Sepsis	0.00% 0/12 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/12 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/12 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	7.1% 1/14 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/26 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/27 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.
Infections and infestations Pneumonia	0.00% 0/12 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/12 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/12 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	7.1% 1/14 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/26 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/27 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.
Infections and infestations Sepsis	0.00% 0/12 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/12 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/12 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/14 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/26 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	3.7% 1/27 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.
Infections and infestations Urinary Tract Infection	0.00% 0/12 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/12 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/12 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	7.1% 1/14 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/26 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/27 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.
Injury, poisoning and procedural complications Femoral Neck Fracture	0.00% 0/12 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/12 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/12 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/14 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	7.7% 2/26 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/27 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.
Injury, poisoning and procedural complications Lumbar Vertebral Fracture	0.00% 0/12 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/12 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/12 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/14 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/26 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	3.7% 1/27 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.
Injury, poisoning and procedural complications Rib Fracture	0.00% 0/12 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/12 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/12 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/14 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	3.8% 1/26 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/27 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.
Metabolism and nutrition disorders Dehydration	0.00% 0/12 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/12 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/12 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/14 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	3.8% 1/26 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/27 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.
Musculoskeletal and connective tissue disorders Musculoskeletal Pain	8.3% 1/12 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/12 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/12 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/14 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/26 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/27 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal Cell Carcinoma	0.00% 0/12 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/12 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/12 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/14 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/26 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	3.7% 1/27 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder transitional Cell Carcinoma	0.00% 0/12 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/12 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/12 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/14 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	3.8% 1/26 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/27 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon Cancer	0.00% 0/12 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	8.3% 1/12 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/12 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/14 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/26 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/27 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.
Nervous system disorders Presyncope	0.00% 0/12 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/12 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/12 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/14 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/26 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	3.7% 1/27 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.
Nervous system disorders Transient Ischaemic Attack	0.00% 0/12 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/12 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/12 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/14 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	3.8% 1/26 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/27 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.
Psychiatric disorders Agitation	0.00% 0/12 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/12 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/12 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/14 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/26 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	3.7% 1/27 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.
Psychiatric disorders Confusional State	0.00% 0/12 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/12 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/12 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/14 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/26 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	3.7% 1/27 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.
Respiratory, thoracic and mediastinal disorders Acute Respiratory Failure	0.00% 0/12 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/12 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/12 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/14 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/26 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	3.7% 1/27 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.
Respiratory, thoracic and mediastinal disorders Pneumonia Aspiration	0.00% 0/12 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/12 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/12 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/14 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/26 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	3.7% 1/27 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.
Respiratory, thoracic and mediastinal disorders Respiratory Failure	0.00% 0/12 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/12 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/12 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	7.1% 1/14 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/26 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/27 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.
Vascular disorders Hypotension	0.00% 0/12 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/12 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/12 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/14 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	3.8% 1/26 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/27 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.

Other adverse events

Measure	Placebo/ELND005 2000mg BID n=12 participants at risk In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive Placebo for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up prior to 15 Dec 2009 were assigned to receive ELND005 2000 mg PO BID for 48 weeks.	250mg/ELND005 2000mg BID n=12 participants at risk In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive ELND005 250 mgPO BID for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up prior to 15 Dec 2009 were assigned to receive ELND005 2000 mg PO BID for 48 weeks.	1000 mg/ELND005 2000 mg BID n=12 participants at risk In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive ELND005 1000 mg PO BID for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up prior to 15 Dec 2009 were assigned to receive ELND005 2000 mg PO BID for 48 weeks.	2000 mg ELND005/ELND005 2000 mg BID n=14 participants at risk In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive ELND005 2000 mg PO BID for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up prior to 15 Dec 2009 were assigned to receive ELND005 2000 mg PO BID for 48 weeks.	Placebo/ELND005 250 mg BID n=26 participants at risk In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive Placebo for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up after 15 Dec 2009 were assigned to receive ELND005 250 mg PO BID for 48 weeks.	250 mg/ELND005 250 mg BID n=27 participants at risk In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive ELND005 250 mg PO BID for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up after 15 Dec 2009 were assigned to receive ELND005 250 mg PO BID for 48 weeks.
Psychiatric disorders Agitation	0.00% 0/12 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/12 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/12 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/14 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	7.7% 2/26 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	14.8% 4/27 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.
Gastrointestinal disorders Constipation	0.00% 0/12 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/12 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/12 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/14 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	7.7% 2/26 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	7.4% 2/27 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.
Gastrointestinal disorders Diarrhoea	0.00% 0/12 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/12 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/12 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/14 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	7.7% 2/26 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	3.7% 1/27 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.
Gastrointestinal disorders Nausea	0.00% 0/12 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/12 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/12 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/14 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	15.4% 4/26 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	3.7% 1/27 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.
Infections and infestations Upper Respiratory Tract Infection	0.00% 0/12 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/12 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/12 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/14 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/26 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	11.1% 3/27 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.
Infections and infestations Urinary Tract Infection	0.00% 0/12 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/12 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/12 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	21.4% 3/14 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	11.5% 3/26 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	11.1% 3/27 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.
Injury, poisoning and procedural complications Fall	0.00% 0/12 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/12 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/12 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/14 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	15.4% 4/26 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	3.7% 1/27 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.
Musculoskeletal and connective tissue disorders Back Pain	0.00% 0/12 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/12 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/12 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/14 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	3.8% 1/26 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	11.1% 3/27 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.
Musculoskeletal and connective tissue disorders Pain In Extremity	0.00% 0/12 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/12 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/12 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/14 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	3.8% 1/26 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	7.4% 2/27 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.
Psychiatric disorders Insomnia	0.00% 0/12 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/12 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/12 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	0.00% 0/14 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	7.7% 2/26 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.	14.8% 4/27 • Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up). For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.

Additional Information

Susan Abushakra, MD, Chief Medical Officer

Transition Therapeutics Ireland Limited and Transition Therapeutics USA Inc.

Phone: +1 650 425 6370

Email: susan.abushakra@tthi.us

Results disclosure agreements

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

Restriction type: GT60