Trial Outcomes & Findings for Safety/Efficacy Study of Levodopa-Carbidopa Intestinal Gel in Parkinson's Subjects (NCT NCT00360568)

NCT ID: NCT00360568

Last Updated: 2015-01-16

Results Overview

AE=any untoward medical occurrence which does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that: results in death; is life-threatening (an event in which the subject was at risk of death at the time of the event); requires inpatient hospitalization or prolongation of an existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; or other important medical events. Treatment-emergent events (TEAE or TESAE)=those starting after the first dose of study drug. Severe=severity reported as 'severe' or missing. Possibly or Probably Treatment Related=drug-event relationship reported as 'possible', 'probable' or missing. Death=a fatal outcome of an SAE or AE.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 62 participants
• Primary outcome timeframe: From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J, plus 30 days.
• Results posted on: 2015-01-16

Participant Flow

Participant milestones

Measure	LCIG (Previous: LCIG + Placebo Capsules) All participants received levodopa-carbidopa intestinal gel (LCIG), delivered through a percutaneous endoscopic gastrostomy with jejunal extension (PEG-J), administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances. In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules.	LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules) All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances. In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules.
Overall Study STARTED	33	29
Overall Study COMPLETED	31	24
Overall Study NOT COMPLETED	2	5

Reasons for withdrawal

Measure	LCIG (Previous: LCIG + Placebo Capsules) All participants received levodopa-carbidopa intestinal gel (LCIG), delivered through a percutaneous endoscopic gastrostomy with jejunal extension (PEG-J), administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances. In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules.	LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules) All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances. In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules.
Overall Study Adverse Event	1	2
Overall Study Lack of Efficacy	1	0
Overall Study Withdrawal by Subject	0	3

Baseline Characteristics

Safety/Efficacy Study of Levodopa-Carbidopa Intestinal Gel in Parkinson's Subjects

Baseline characteristics by cohort

Measure	LCIG (Previous: LCIG + Placebo Capsules) n=33 Participants All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances. In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules.	LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules) n=29 Participants All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances. In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules.	Total n=62 Participants Total of all reporting groups
Age, Continuous	63.6 years STANDARD_DEVIATION 9.0 • n=5 Participants	64.8 years STANDARD_DEVIATION 6.6 • n=7 Participants	64.1 years STANDARD_DEVIATION 7.9 • n=5 Participants
Age, Customized <65 years	19 participants n=5 Participants	13 participants n=7 Participants	32 participants n=5 Participants
Age, Customized >=65 years	14 participants n=5 Participants	16 participants n=7 Participants	30 participants n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	8 Participants n=7 Participants	18 Participants n=5 Participants
Sex: Female, Male Male	23 Participants n=5 Participants	21 Participants n=7 Participants	44 Participants n=5 Participants

PRIMARY outcome

Timeframe: From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J, plus 30 days.

Population: Safety Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion.

AE=any untoward medical occurrence which does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that: results in death; is life-threatening (an event in which the subject was at risk of death at the time of the event); requires inpatient hospitalization or prolongation of an existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; or other important medical events. Treatment-emergent events (TEAE or TESAE)=those starting after the first dose of study drug. Severe=severity reported as 'severe' or missing. Possibly or Probably Treatment Related=drug-event relationship reported as 'possible', 'probable' or missing. Death=a fatal outcome of an SAE or AE.

Outcome measures

Measure	LCIG (Previous: LCIG + Placebo Capsules) n=33 Participants All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances. In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules.	LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules) n=29 Participants All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances. In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules.	LCIG (All Participants) n=62 Participants All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths and Discontinuations Due to AEs Deaths	0 participants	0 participants	0 participants
Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths and Discontinuations Due to AEs TE Deaths	0 participants	0 participants	0 participants
Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths and Discontinuations Due to AEs >=1 SAE	5 participants	9 participants	14 participants
Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths and Discontinuations Due to AEs >=1 TESAE	5 participants	9 participants	14 participants
Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths and Discontinuations Due to AEs >=1 TEAE Leading to Study Termination	1 participants	2 participants	3 participants
Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths and Discontinuations Due to AEs >=1 TEAE	31 participants	28 participants	59 participants
Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths and Discontinuations Due to AEs >=1 Severe TEAE	5 participants	10 participants	15 participants
Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths and Discontinuations Due to AEs >=1 Possibly or ProbablyTreatment-Related TEAE	28 participants	20 participants	48 participants
Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths and Discontinuations Due to AEs No TEAEs	2 participants	1 participants	3 participants

PRIMARY outcome

Timeframe: 12 months

Population: Safety Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion.

Complications of the infusion device were collected. Pump, intestinal tube, PEG, stoma, and other complications included (but were not limited to) device breakage, device leakage, device malfunction, device misuse, device occlusion, intentional and unintentional device removal by participant, complication of device insertion, device dislocation, device breakage, device dislocation, and device site reaction.

Outcome measures

Measure	LCIG (Previous: LCIG + Placebo Capsules) n=33 Participants All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances. In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules.	LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules) n=29 Participants All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances. In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules.	LCIG (All Participants) n=62 Participants All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
Number of Participants With Device Complications >=1 Complication	26 participants	24 participants	50 participants
Number of Participants With Device Complications Pump Complication	18 participants	16 participants	34 participants
Number of Participants With Device Complications Intestinal Tube Complication	15 participants	16 participants	31 participants
Number of Participants With Device Complications PEG Complication	11 participants	11 participants	22 participants
Number of Participants With Device Complications Stoma Complication	12 participants	15 participants	27 participants
Number of Participants With Device Complications Other	6 participants	4 participants	10 participants

PRIMARY outcome

Timeframe: 12 months

Population: Safety Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion and had an assessment.

Terms abbreviated in the table include females (f) and males (m).

Outcome measures

Measure	LCIG (Previous: LCIG + Placebo Capsules) n=33 Participants All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances. In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules.	LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules) n=28 Participants All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances. In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules.	LCIG (All Participants) n=61 Participants All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
Number of Participants With Potentially Clinically Significant Values for Hematology Parameters Red Blood Cells <2.0 10^12/L (f); <2.5 10^12/L (m)	0 participants	0 participants	0 participants
Number of Participants With Potentially Clinically Significant Values for Hematology Parameters Haemoglobin <90 g/L (f); <100 g/L (m)	0 participants	1 participants	1 participants
Number of Participants With Potentially Clinically Significant Values for Hematology Parameters Haematocrit <30% (f); <34% (m)	1 participants	1 participants	2 participants
Number of Participants With Potentially Clinically Significant Values for Hematology Parameters White Blood Cells <2.8 10^9/L	0 participants	0 participants	0 participants
Number of Participants With Potentially Clinically Significant Values for Hematology Parameters White Blood Cells >16.0 10^9/L	0 participants	0 participants	0 participants
Number of Participants With Potentially Clinically Significant Values for Hematology Parameters Neutrophils, Absolute <1.2 10^9/L	0 participants	0 participants	0 participants
Number of Participants With Potentially Clinically Significant Values for Hematology Parameters Lymphocytes >80%	0 participants	0 participants	0 participants
Number of Participants With Potentially Clinically Significant Values for Hematology Parameters Lymphocytes, Absolute <.75 10^9/L	2 participants	0 participants	2 participants
Number of Participants With Potentially Clinically Significant Values for Hematology Parameters Eosinophils >10%	0 participants	0 participants	0 participants
Number of Participants With Potentially Clinically Significant Values for Hematology Parameters Monocytes >30%	0 participants	0 participants	0 participants
Number of Participants With Potentially Clinically Significant Values for Hematology Parameters Platelet Count <95 10^9/L	0 participants	0 participants	0 participants
Number of Participants With Potentially Clinically Significant Values for Hematology Parameters Platelet Count >700 10^9/L	0 participants	0 participants	0 participants
Number of Participants With Potentially Clinically Significant Values for Hematology Parameters Mean Corpuscular Volume <60 fL	0 participants	0 participants	0 participants
Number of Participants With Potentially Clinically Significant Values for Hematology Parameters Mean Corpuscular Volume >120 fL	0 participants	0 participants	0 participants

PRIMARY outcome

Timeframe: 12 months

Population: Safety Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion; n=number of participants with an assessment.

Terms abbreviated in the table include upper limit of normal (ULN), male (m), and female (f).

Outcome measures

Measure	LCIG (Previous: LCIG + Placebo Capsules) n=33 Participants All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances. In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules.	LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules) n=29 Participants All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances. In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules.	LCIG (All Participants) n=62 Participants All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
Number of Participants With Potentially Clinically Significant Values for Clinical Chemistry Parameters Calcium >3.0 mmol/L; n=33, 28, 61	0 participants	0 participants	0 participants
Number of Participants With Potentially Clinically Significant Values for Clinical Chemistry Parameters Uric Acid>500µmol/L(f);>590µmol/L(m);n=33, 28, 61	0 participants	0 participants	0 participants
Number of Participants With Potentially Clinically Significant Values for Clinical Chemistry Parameters Sodium <126 mmol/L; n=33, 28, 61	0 participants	0 participants	0 participants
Number of Participants With Potentially Clinically Significant Values for Clinical Chemistry Parameters Sodium >156 mmol/L; n=33, 28, 61	0 participants	0 participants	0 participants
Number of Participants With Potentially Clinically Significant Values for Clinical Chemistry Parameters Albumin <25 g/L; n=27, 20, 47	0 participants	0 participants	0 participants
Number of Participants With Potentially Clinically Significant Values for Clinical Chemistry Parameters Albumin >70 g/L; n=27, 20, 47	0 participants	0 participants	0 participants
Number of Participants With Potentially Clinically Significant Values for Clinical Chemistry Parameters Potassium <3.0 mmol/L; n=33, 28, 61	0 participants	0 participants	0 participants
Number of Participants With Potentially Clinically Significant Values for Clinical Chemistry Parameters Potassium >6.0 mmol/L; n=33, 28, 61	0 participants	0 participants	0 participants
Number of Participants With Potentially Clinically Significant Values for Clinical Chemistry Parameters Creatinine >177 µmol/L; n=33, 28, 61	0 participants	0 participants	0 participants
Number of Participants With Potentially Clinically Significant Values for Clinical Chemistry Parameters Calcium <1.75 mmol/L; n=33, 28, 61	0 participants	0 participants	0 participants
Number of Participants With Potentially Clinically Significant Values for Clinical Chemistry Parameters Total Protein <45 g/L; n=33, 28, 61	0 participants	0 participants	0 participants
Number of Participants With Potentially Clinically Significant Values for Clinical Chemistry Parameters Total Bilirubin >2xULN; n=33, 28, 61	0 participants	0 participants	0 participants
Number of Participants With Potentially Clinically Significant Values for Clinical Chemistry Parameters Aspartate Aminotransferase >3xULN; n=33, 28, 61	0 participants	0 participants	0 participants
Number of Participants With Potentially Clinically Significant Values for Clinical Chemistry Parameters Alanine Aminotransferase >3xULN; n=33, 28, 61	0 participants	0 participants	0 participants
Number of Participants With Potentially Clinically Significant Values for Clinical Chemistry Parameters Gamma-glutamyl Transpeptidase >3x ULN;n=33, 28, 61	1 participants	1 participants	2 participants
Number of Participants With Potentially Clinically Significant Values for Clinical Chemistry Parameters Lactate dehydrogenase >3x ULN; n=33, 28, 61	0 participants	0 participants	0 participants
Number of Participants With Potentially Clinically Significant Values for Clinical Chemistry Parameters Alkaline Phosphatase >400 U/L; n=33, 28, 61	0 participants	0 participants	0 participants
Number of Participants With Potentially Clinically Significant Values for Clinical Chemistry Parameters Creatine Phosphokinase >3x ULN; n=33, 28, 61	0 participants	0 participants	0 participants
Number of Participants With Potentially Clinically Significant Values for Clinical Chemistry Parameters Non-fasting Glucose <2.78 mmol/L; n=33, 28, 61	0 participants	0 participants	0 participants
Number of Participants With Potentially Clinically Significant Values for Clinical Chemistry Parameters Non-fasting Glucose >16.0 mmol/L; n=33, 28, 61	0 participants	0 participants	0 participants
Number of Participants With Potentially Clinically Significant Values for Clinical Chemistry Parameters Blood Urea Nitrogen >10.8 mmol/L; n=28, 22, 50	3 participants	0 participants	3 participants
Number of Participants With Potentially Clinically Significant Values for Clinical Chemistry Parameters Cholesterol >12.9 mmol/L; n=33, 28, 61	0 participants	0 participants	0 participants
Number of Participants With Potentially Clinically Significant Values for Clinical Chemistry Parameters Triglycerides >5.6 mmol/L; n=33, 28, 61	0 participants	0 participants	0 participants

PRIMARY outcome

Timeframe: 12 months

Population: Safety Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion; n=number of participants with assessment.

Terms abbreviated in the table include supine systolic blood pressure (SuSBP), standing systolic blood pressure (StSBP), orthostatic systolic blood pressure (OSBP), supine diastolic blood pressure (SuDBP), standing diastolic blood pressure (StDBP), orthostatic diastolic blood pressure (ODBP), supine pulse (SuP) in beats per minute (bpm), standing pulse (StP), and body temperature (Temp). Increase and decrease are signified by ↑ and ↓, respectively.

Outcome measures

Measure	LCIG (Previous: LCIG + Placebo Capsules) n=33 Participants All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances. In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules.	LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules) n=29 Participants All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances. In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules.	LCIG (All Participants) n=62 Participants All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
Number of Participants With Potentially Clinically Significant Vital Sign Parameters SuSBP <=90 and >30 mm Hg ↓ from BL; n=33, 29, 62	3 participants	0 participants	3 participants
Number of Participants With Potentially Clinically Significant Vital Sign Parameters SuSBP >=180 and >40 mm Hg ↑ from BL; n=33, 29, 62	1 participants	2 participants	3 participants
Number of Participants With Potentially Clinically Significant Vital Sign Parameters StSBP <=90 and >30 mm Hg ↓ from BL; n=33, 29, 62	4 participants	7 participants	11 participants
Number of Participants With Potentially Clinically Significant Vital Sign Parameters StSBP >=180 and >40 mm Hg ↑ from BL; n=33, 29, 62	0 participants	0 participants	0 participants
Number of Participants With Potentially Clinically Significant Vital Sign Parameters OSBP: ↓ >=30 mm Hg Supine to Standing; n=33,29,62	8 participants	11 participants	19 participants
Number of Participants With Potentially Clinically Significant Vital Sign Parameters SuDBP <=50 and >30 mm Hg ↓ from BL; n=33, 29, 62	0 participants	1 participants	1 participants
Number of Participants With Potentially Clinically Significant Vital Sign Parameters SuDBP >=105 and >30 mm Hg ↑ from BL; n=33, 29, 62	1 participants	1 participants	2 participants
Number of Participants With Potentially Clinically Significant Vital Sign Parameters StDBP <=50 and >30 mm Hg ↓ from BL; n=33, 29, 62	1 participants	0 participants	1 participants
Number of Participants With Potentially Clinically Significant Vital Sign Parameters StDBP >=105 and >30 mm Hg ↑ from BL; (n=33,29,62)	2 participants	1 participants	3 participants
Number of Participants With Potentially Clinically Significant Vital Sign Parameters ODBP: ↓ >=20 mm Hg Supine to Standing; n=33,29,62	7 participants	7 participants	14 participants
Number of Participants With Potentially Clinically Significant Vital Sign Parameters SuP <=50 and >30 bpm ↓ from BL; n=33, 29, 62	1 participants	0 participants	1 participants
Number of Participants With Potentially Clinically Significant Vital Sign Parameters SuP >=120 and >30 bpm ↑ from BL; n=33, 29, 62	0 participants	0 participants	0 participants
Number of Participants With Potentially Clinically Significant Vital Sign Parameters StP <=50 and >30 bpm ↓ from BL; n=33, 29, 62	0 participants	0 participants	0 participants
Number of Participants With Potentially Clinically Significant Vital Sign Parameters StP >=120 and >30 bpm ↑ from BL; n=33, 29, 62	0 participants	1 participants	1 participants
Number of Participants With Potentially Clinically Significant Vital Sign Parameters Temp >=38.3° and >=1.1°C ↑ from BL; n=33, 29, 62	0 participants	0 participants	0 participants
Number of Participants With Potentially Clinically Significant Vital Sign Parameters Weight <=7% ↓ from BL; n=33, 27, 60	5 participants	5 participants	10 participants
Number of Participants With Potentially Clinically Significant Vital Sign Parameters Weight >=7% ↑ from BL; n=33, 27, 60	8 participants	8 participants	16 participants

PRIMARY outcome

Timeframe: 12 months

Population: Safety Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion.

Terms abbreviated in the table include heart rate (HR) in beats per minute (bpm), PR interval (PRI), QT interval corrected for heart rate using Bazett's formula (QTcB), and QT interval corrected for heart rate using Fridericia's formula (QTcF). Increase and decrease are signified by ↑ and ↓, respectively.

Outcome measures

Measure	LCIG (Previous: LCIG + Placebo Capsules) n=33 Participants All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances. In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules.	LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules) n=29 Participants All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances. In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules.	LCIG (All Participants) n=62 Participants All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Parameters HR <=50 and >30 bpm ↓ from BL; n=33, 28, 61	0 participants	0 participants	0 participants
Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Parameters HR >=120 and >30 bpm ↑ from BL; n=33, 28, 61	0 participants	0 participants	0 participants
Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Parameters PR Interval <120 msec; n=33, 27, 60	1 participants	0 participants	1 participants
Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Parameters PR Interval >220 msec; n=33, 27, 60	1 participants	0 participants	1 participants
Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Parameters QTcB Interval >480 msec; n=33, 27, 60	0 participants	0 participants	0 participants
Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Parameters QTcB Interval >60 msec ↑ from BL; n=33, 27, 60	0 participants	0 participants	0 participants
Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Parameters QTcF Interval >480 msec; n=33, 27, 60	0 participants	0 participants	0 participants
Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Parameters QTcF Interval >60 msec ↑ from BL; n=33, 27, 60	0 participants	0 participants	0 participants

PRIMARY outcome

Timeframe: Baseline, Endpoint (Month 12 or last post-baseline visit)

Population: Safety Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion.

To prospectively monitor for the possible development of sleep attacks, participants were asked if they had experienced any events in which they fell asleep suddenly or unexpectedly, including while engaged in some activity (e.g., eating/drinking, speaking, or driving) or at rest, with or without any previous warning of sleepiness.

Outcome measures

Measure	LCIG (Previous: LCIG + Placebo Capsules) n=33 Participants All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances. In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules.	LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules) n=29 Participants All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances. In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules.	LCIG (All Participants) n=62 Participants All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
Number of Participants With Sleep Attacks at Baseline and Endpoint Participants with >=1 Sleep Attacks at Baseline	0 participants	0 participants	0 participants
Number of Participants With Sleep Attacks at Baseline and Endpoint Participants with >=1 Sleep Attacks at Endpoint	0 participants	0 participants	0 participants

PRIMARY outcome

Timeframe: Baseline, Post-baseline (up to Month 12)

Population: Safety Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion; n=number of participants with assessment at timepoint.

The MIDI is a validated assessment of impulsive behavior consisting of a semistructured clinical interview assessing pathological gambling, trichotillomania (compulsive hair-pulling), kleptomania (compulsive stealing), pyromania (compulsive fire-setting), intermittent explosive disorder, compulsive buying, and compulsive sexual behavior.

Outcome measures

Measure	LCIG (Previous: LCIG + Placebo Capsules) n=33 Participants All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances. In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules.	LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules) n=29 Participants All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances. In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules.	LCIG (All Participants) n=62 Participants All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
Summary of Minnesota Impulsive Disorder Interview (MIDI) Assessment of Intense Impulsive Behavior at Baseline (BL) and Post-baseline (PBL) BL Pathological Gambling; n=33, 29, 62	0 participants	0 participants	0 participants
Summary of Minnesota Impulsive Disorder Interview (MIDI) Assessment of Intense Impulsive Behavior at Baseline (BL) and Post-baseline (PBL) BL Trichotillomania; n=33, 29, 62	0 participants	0 participants	0 participants
Summary of Minnesota Impulsive Disorder Interview (MIDI) Assessment of Intense Impulsive Behavior at Baseline (BL) and Post-baseline (PBL) BL Kleptomania; n=33, 29, 62	0 participants	0 participants	0 participants
Summary of Minnesota Impulsive Disorder Interview (MIDI) Assessment of Intense Impulsive Behavior at Baseline (BL) and Post-baseline (PBL) BL Pyromania; n=33, 29, 62	0 participants	0 participants	0 participants
Summary of Minnesota Impulsive Disorder Interview (MIDI) Assessment of Intense Impulsive Behavior at Baseline (BL) and Post-baseline (PBL) BL Intermittent Explosive Disorder; n=33, 29, 62	0 participants	0 participants	0 participants
Summary of Minnesota Impulsive Disorder Interview (MIDI) Assessment of Intense Impulsive Behavior at Baseline (BL) and Post-baseline (PBL) BL Compulsive Buying; n=33, 29, 62	0 participants	1 participants	1 participants
Summary of Minnesota Impulsive Disorder Interview (MIDI) Assessment of Intense Impulsive Behavior at Baseline (BL) and Post-baseline (PBL) BL Compulsive Sexual Behavior; n=33, 29, 62	0 participants	1 participants	1 participants
Summary of Minnesota Impulsive Disorder Interview (MIDI) Assessment of Intense Impulsive Behavior at Baseline (BL) and Post-baseline (PBL) PBL Pathological Gambling; n=33, 27, 60	0 participants	0 participants	0 participants
Summary of Minnesota Impulsive Disorder Interview (MIDI) Assessment of Intense Impulsive Behavior at Baseline (BL) and Post-baseline (PBL) PBL Trichotillomania; n=33, 27, 60	0 participants	0 participants	0 participants
Summary of Minnesota Impulsive Disorder Interview (MIDI) Assessment of Intense Impulsive Behavior at Baseline (BL) and Post-baseline (PBL) PBL Kleptomania; n=33, 27, 60	0 participants	0 participants	0 participants
Summary of Minnesota Impulsive Disorder Interview (MIDI) Assessment of Intense Impulsive Behavior at Baseline (BL) and Post-baseline (PBL) PBL Pyromania; n=33, 27, 60	0 participants	0 participants	0 participants
Summary of Minnesota Impulsive Disorder Interview (MIDI) Assessment of Intense Impulsive Behavior at Baseline (BL) and Post-baseline (PBL) PBL Intermittent Explosive Disorder; n=33, 27, 60	0 participants	0 participants	0 participants
Summary of Minnesota Impulsive Disorder Interview (MIDI) Assessment of Intense Impulsive Behavior at Baseline (BL) and Post-baseline (PBL) PBL Compulsive Buying; n=33, 27, 60	1 participants	0 participants	1 participants
Summary of Minnesota Impulsive Disorder Interview (MIDI) Assessment of Intense Impulsive Behavior at Baseline (BL) and Post-baseline (PBL) PBL Compulsive Sexual Behavior; n=33, 27, 60	2 participants	0 participants	2 participants

PRIMARY outcome

Timeframe: Baseline, Endpoint (Month 12 or last post-baseline visit)

Population: Safety Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion; n=number of participants with assessment at timepoint.

The AIMS is an investigator-completed rating scale that has a total of 12 items rating involuntary movements of various areas of the participant's body. Items 1 through 10 are rated on a 5-point scale of severity from 0 (none), 1 (minimal), 2 (mild), 3 (moderate), to 4 (severe), and items 11 and 12 are yes/no questions concerning problems with teeth or dentures. The total AIMS score was calculated by summing items 1-10, with a possible range of 0-40; a negative change indicates improvement. The AIMS was to be performed at consistent times, when the subject was experiencing his/her worst "On" time (dyskinesia [involuntary muscle movement]).

Outcome measures

Measure	LCIG (Previous: LCIG + Placebo Capsules) n=33 Participants All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances. In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules.	LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules) n=29 Participants All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances. In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules.	LCIG (All Participants) n=62 Participants All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score at Endpoint Baseline; n=33, 29, 62	6.1 units on a scale Standard Deviation 6.0	5.3 units on a scale Standard Deviation 6.3	5.7 units on a scale Standard Deviation 6.1
Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score at Endpoint Change from Baseline at Endpoint; n=33, 27, 60	6.1 units on a scale Standard Deviation 6.0	5.0 units on a scale Standard Deviation 6.3	5.6 units on a scale Standard Deviation 6.1

PRIMARY outcome

Timeframe: up to Month 12

Population: Safety Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion.

A comprehensive assessment for the presence of melanoma was performed during the screening period and at early termination/end of study by a dermatologist experienced with the diagnosis of the condition. If a suspicious lesion was present, a biopsy was obtained for proper diagnosis.

Outcome measures

Measure	LCIG (Previous: LCIG + Placebo Capsules) n=33 Participants All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances. In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules.	LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules) n=29 Participants All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances. In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules.	LCIG (All Participants) n=62 Participants All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
Number of Participants With Confirmed Cases of Melanoma	0 participants	0 participants	0 participants

PRIMARY outcome

Timeframe: up to 12 months

Population: Safety Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion and had a neurological examination.

The neurologic examination was to be done during "On" time. The neurological examination assessed: cranial nerves - assessment of cranial nerves II - XII, excluding fundoscopic examination; motor system - assessment of tone, strength, and abnormal movements; sensory system - including light touch, pinprick, joint position, and vibratory sense; reflexes - assessment of deep tendon reflexes and plantar responses (Babinski sign); coordination - assessment of upper and lower extremities; gait - assessment of base and tandem gait; station - assessment of posture and stability.

Outcome measures

Measure	LCIG (Previous: LCIG + Placebo Capsules) n=19 Participants All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances. In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules.	LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules) n=15 Participants All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances. In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules.	LCIG (All Participants) n=34 Participants All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
Number of Participants With Clinically Significant Neurological Examination Findings Cranial Nerve	0 participants	0 participants	0 participants
Number of Participants With Clinically Significant Neurological Examination Findings Motor System	3 participants	2 participants	5 participants
Number of Participants With Clinically Significant Neurological Examination Findings Sensory System	2 participants	1 participants	3 participants
Number of Participants With Clinically Significant Neurological Examination Findings Reflexes	1 participants	1 participants	2 participants
Number of Participants With Clinically Significant Neurological Examination Findings Coordination	1 participants	0 participants	1 participants
Number of Participants With Clinically Significant Neurological Examination Findings Gait	2 participants	2 participants	4 participants
Number of Participants With Clinically Significant Neurological Examination Findings Station	2 participants	2 participants	4 participants

PRIMARY outcome

Timeframe: up to 12 months

Population: Safety Data Set: all enrolled participants who received at least one study S187-3-3003 LCIG infusion with a C-SSRS assessment during the study.

The Columbia-Suicide Severity Rating Scale (C-SSRS) is a systematically administered instrument developed to track suicidal adverse events across a treatment study. The instrument is designed to assess suicidal behavior and ideation, track and assess all suicidal events, as well as the lethality of attempts. Suicidal ideation categories include the following: wish to be dead; nonspecific active suicidal thoughts; active suicidal ideation without intent to act; active suicidal ideation with some intent to act but no plan; active suicidal ideation with plan and intent. Suicidal behavior categories include the following: actual attempt; interrupted attempt; aborted attempt; preparatory acts or behavior; suicidal behavior; completed suicide.

Outcome measures

Measure	LCIG (Previous: LCIG + Placebo Capsules) n=12 Participants All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances. In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules.	LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules) n=7 Participants All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances. In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules.	LCIG (All Participants) n=19 Participants All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
Columbia-Suicide Severity Rating Scale (C-SSRS) Findings Participants with Suicidal Ideations	0 participants	0 participants	0 participants
Columbia-Suicide Severity Rating Scale (C-SSRS) Findings Participants with Suicidal Ideations Only	0 participants	0 participants	0 participants
Columbia-Suicide Severity Rating Scale (C-SSRS) Findings Participants with Suicidal Behaviors	0 participants	0 participants	0 participants
Columbia-Suicide Severity Rating Scale (C-SSRS) Findings Participants with Suicidal Behaviors or Ideations	0 participants	0 participants	0 participants

PRIMARY outcome

Timeframe: 12 months

Population: Safety Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion.

Concomitant medications include medications started on or after the first open-label LCIG infusion as well as medications started prior to the first open-label infusion but continued during the study.

Outcome measures

Measure	LCIG (Previous: LCIG + Placebo Capsules) n=33 Participants All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances. In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules.	LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules) n=29 Participants All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances. In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules.	LCIG (All Participants) n=62 Participants All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
Number of Participants Taking at Least 1 Concomitant Medication During the Study	33 participants	29 participants	62 participants

SECONDARY outcome

Timeframe: Baseline, Endpoint (Month 12 or last post-baseline visit)

Population: Full Analysis Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion and had data for baseline and at least 1 post-baseline assessment.

Based on the Parkinson's Disease Symptom Diary. "On" time is when PD symptoms are well controlled by the drug. "Off" time is when PD symptoms are not adequately controlled by the drug. The diary is completed every 30 minutes for the full 24 hours of each of 3 days prior to selected clinic visits. It reflects both time awake and time asleep. Daily totals are normalized to a 16-hour scale (i.e. 16 hours of awake time). The normalized totals for the 3 days prior to the visit are averaged for the analysis. Negative change from baseline for "off" time indicates improvement.

Outcome measures

Measure	LCIG (Previous: LCIG + Placebo Capsules) n=32 Participants All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances. In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules.	LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules) n=27 Participants All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances. In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules.	LCIG (All Participants) n=59 Participants All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
Change From Baseline in Average Daily "Off" Time at Endpoint Baseline	2.87 hours Standard Deviation 2.18	5.18 hours Standard Deviation 2.05	3.92 hours Standard Deviation 2.40
Change From Baseline in Average Daily "Off" Time at Endpoint Change from Baseline at Endpoint	-0.42 hours Standard Deviation 2.67	-2.34 hours Standard Deviation 2.78	-1.30 hours Standard Deviation 2.86

SECONDARY outcome

Timeframe: Baseline, Endpoint (Month 12 or last post-baseline visit)

Population: Full Analysis Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion and had data for baseline and at least 1 post-baseline assessment.

Based on the Parkinson's Disease Symptom Diary. "On" time is when PD symptoms are well controlled by the drug. "Off" time is when PD symptoms are not adequately controlled by the drug. The diary is completed every 30 minutes for the full 24 hours of each of 3 days prior to selected clinic visits. It reflects both time awake and time asleep. Daily totals are normalized to a 16-hour scale (i.e. 16 hours of awake time). The normalized totals for the 3 days prior to the visit are averaged for the analysis.

Outcome measures

Measure	LCIG (Previous: LCIG + Placebo Capsules) n=32 Participants All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances. In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules.	LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules) n=27 Participants All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances. In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules.	LCIG (All Participants) n=59 Participants All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
Change From Baseline in Average Daily Normalized "On" Time With Troublesome Dyskinesia at Endpoint Baseline	1.09 hours Standard Deviation 2.07	0.82 hours Standard Deviation 1.54	0.97 hours Standard Deviation 1.84
Change From Baseline in Average Daily Normalized "On" Time With Troublesome Dyskinesia at Endpoint Change from Baseline at Endpoint	-0.58 hours Standard Deviation 2.18	0.15 hours Standard Deviation 2.17	-0.24 hours Standard Deviation 2.19

SECONDARY outcome

Timeframe: Baseline, Endpoint (Month 12 or last post-baseline visit)

Population: Full Analysis Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion and had data for baseline and at least 1 post-baseline assessment.

Based on the Parkinson's Disease Symptom Diary. "On" time is when PD symptoms are well controlled by the drug. "Off" time is when PD symptoms are not adequately controlled by the drug. "On" time without troublesome dyskinesia (involuntary muscle movement) is defined as "on" time without dyskinesia and "on" time with non-troublesome dyskinesia. The diary is completed every 30 minutes for the full 24 hours of each of 3 days prior to selected clinic visits. It reflects both time awake and time asleep. Daily totals are normalized to a 16-hour scale (i.e. 16 hours of awake time). The normalized totals for the 3 days prior to the visit are averaged for the analysis. Positive change from Baseline for "on" time without troublesome dyskinesia indicates improvement.

Outcome measures

Measure	LCIG (Previous: LCIG + Placebo Capsules) n=32 Participants All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances. In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules.	LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules) n=27 Participants All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances. In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules.	LCIG (All Participants) n=59 Participants All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
Change From Baseline in Average Daily "On" Time Without Troublesome Dyskinesia at Month 12 Baseline	12.04 hours Standard Deviation 2.42	10.00 hours Standard Deviation 2.62	11.11 hours Standard Deviation 2.69
Change From Baseline in Average Daily "On" Time Without Troublesome Dyskinesia at Month 12 Change from Baseline at Endpoint	1.00 hours Standard Deviation 2.58	2.19 hours Standard Deviation 3.70	1.54 hours Standard Deviation 3.17

SECONDARY outcome

Timeframe: Baseline, Endpoint (Month 12 or last post-baseline visit)

Population: Full Analysis Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion and had data for baseline and at least 1 post-baseline assessment; n=number of participants with assessment at timepoint.

The CGI-S is a global assessment by the Investigator of current symptomatology and impact of illness on functioning. The ratings of the CGI-S are as follows: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, and 7 = among the most extremely ill. The CGI-I is a global assessment by the Investigator of the change in clinical status since the start of treatment. The CGI-I ratings are as follows: 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, 7 = very much worse.

Outcome measures

Measure	LCIG (Previous: LCIG + Placebo Capsules) n=33 Participants All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances. In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules.	LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules) n=29 Participants All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances. In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules.	LCIG (All Participants) n=62 Participants All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
Clinical Global Impression - Status (CGI-S) Score at Baseline and Clinical Global Impression - Improvement (CGI-I) Score at Endpoint CGI-S at Baseline; n=32, 28, 60	3.0 units on a scale Standard Deviation 1.3	3.7 units on a scale Standard Deviation 1.3	3.3 units on a scale Standard Deviation 1.3
Clinical Global Impression - Status (CGI-S) Score at Baseline and Clinical Global Impression - Improvement (CGI-I) Score at Endpoint CGI-I at Endpoint; n=33, 29, 62	2.1 units on a scale Standard Deviation 1.2	2.3 units on a scale Standard Deviation 1.6	2.2 units on a scale Standard Deviation 1.4

SECONDARY outcome

Timeframe: Baseline, Endpoint (Month 12 or last post-baseline visit)

Population: Full Analysis Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion and had data for baseline and at least 1 post-baseline assessment.

The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The Part I Score is the sum of the answers to the 4 questions that comprise Part I, each of which are measured on a 5-point scale (0-4). The Part I score ranges from 0-16 and higher scores are associated with more disability.

Outcome measures

Measure	LCIG (Previous: LCIG + Placebo Capsules) n=33 Participants All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances. In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules.	LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules) n=26 Participants All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances. In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules.	LCIG (All Participants) n=59 Participants All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part I Score at Endpoint Baseline	1.6 units on a scale Standard Deviation 1.8	1.2 units on a scale Standard Deviation 1.0	1.4 units on a scale Standard Deviation 1.5
Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part I Score at Endpoint Change from Baseline at Endpoint	0.3 units on a scale Standard Deviation 1.9	0.7 units on a scale Standard Deviation 1.7	0.5 units on a scale Standard Deviation 1.8

SECONDARY outcome

Timeframe: Baseline, Endpoint (Month 12 or last post-baseline visit)

Population: Full Analysis Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion and had data for baseline and at least 1 post-baseline assessment.

The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The Part II score is the sum of the answers to the 13 questions that comprise Part II, each of which are measured on a 5-point scale (0-4). The Part II score ranges from 0-52 and higher scores are associated with more disability.

Outcome measures

Measure	LCIG (Previous: LCIG + Placebo Capsules) n=33 Participants All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances. In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules.	LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules) n=26 Participants All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances. In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules.	LCIG (All Participants) n=59 Participants All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part II Score at Endpoint Baseline	8.6 units on a scale Standard Deviation 6.5	12.1 units on a scale Standard Deviation 7.0	10.1 units on a scale Standard Deviation 6.9
Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part II Score at Endpoint Change from Baseline at Endpoint	0.5 units on a scale Standard Deviation 3.4	-1.0 units on a scale Standard Deviation 7.0	-0.2 units on a scale Standard Deviation 5.3

SECONDARY outcome

Timeframe: Baseline, Endpoint (Month 12 or last post-baseline visit)

Population: Full Analysis Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion and had data for baseline and at least 1 post-baseline assessment.

The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The Part III score is the sum of the 27 answers provided to the 14 Part III questions, each of which are measured on a 5-point scale (0-4). The Part III score ranges from 0-108 and higher scores are associated with more disability.

Outcome measures

Measure	LCIG (Previous: LCIG + Placebo Capsules) n=33 Participants All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances. In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules.	LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules) n=25 Participants All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances. In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules.	LCIG (All Participants) n=58 Participants All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Score at Endpoint Baseline	16.2 units on a scale Standard Deviation 12.7	19.0 units on a scale Standard Deviation 10.5	17.4 units on a scale Standard Deviation 11.8
Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Score at Endpoint Change from Baseline at Endpoint	1.5 units on a scale Standard Deviation 7.0	-0.5 units on a scale Standard Deviation 10.4	0.6 units on a scale Standard Deviation 8.6

SECONDARY outcome

Timeframe: Baseline, Endpoint (Month 12 or last post-baseline visit)

Population: Full Analysis Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion and had data for baseline and at least 1 post-baseline assessment.

The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The total score is the sum of the responses to the 31 questions (44 answers) that comprise Parts I-III of the scale. The total score will range from 0-176, with 176 representing the worst (total) disability, and 0 representing no disability.

Outcome measures

Measure	LCIG (Previous: LCIG + Placebo Capsules) n=33 Participants All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances. In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules.	LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules) n=25 Participants All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances. In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules.	LCIG (All Participants) n=58 Participants All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Total Score at Endpoint Baseline	26.4 units on a scale Standard Deviation 18.9	32.4 units on a scale Standard Deviation 16.1	29.0 units on a scale Standard Deviation 17.8
Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Total Score at Endpoint Change from Baseline at Endpoint	2.3 units on a scale Standard Deviation 9.0	-1.0 units on a scale Standard Deviation 15.0	0.9 units on a scale Standard Deviation 12.0

SECONDARY outcome

Timeframe: Baseline, Endpoint (Month 12 or last post-baseline visit)

Population: Full Analysis Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion and had data for baseline and at least 1 post-baseline assessment.

The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The Part IV Score is the sum of the answers to the 11 questions that comprise Part IV, each of which are measured on a 5-point scale (0-4) or a 2-point scale (0 or 1). The Part IV score ranges from 0-23 and higher scores are associated with more disability.

Outcome measures

Measure	LCIG (Previous: LCIG + Placebo Capsules) n=33 Participants All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances. In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules.	LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules) n=26 Participants All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances. In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules.	LCIG (All Participants) n=59 Participants All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part IV Score at Endpoint Baseline	5.8 units on a scale Standard Deviation 2.7	7.0 units on a scale Standard Deviation 3.2	6.3 units on a scale Standard Deviation 3.0
Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part IV Score at Endpoint Change from Baseline at Endpoint	-1.6 units on a scale Standard Deviation 2.5	-1.4 units on a scale Standard Deviation 3.0	-1.5 units on a scale Standard Deviation 2.7

SECONDARY outcome

Timeframe: Baseline, Endpoint (Month 12 or last post-baseline visit)

Population: Full Analysis Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion and had data for baseline and at least 1 post-baseline assessment.

The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. These include: mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort. The PDQ-39 Summary Index is the sum of all answers divided by the highest score possible (i.e. number of answers multiplied by 4) which is multiplied by 100 to put the score on a 0-100 scale. Higher scores are associated with more severe symptoms.

Outcome measures

Measure	LCIG (Previous: LCIG + Placebo Capsules) n=32 Participants All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances. In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules.	LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules) n=26 Participants All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances. In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules.	LCIG (All Participants) n=58 Participants All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Summary Index at Endpoint Baseline	22.2 units on a scale Standard Deviation 17.3	32.8 units on a scale Standard Deviation 17.0	26.9 units on a scale Standard Deviation 17.8
Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Summary Index at Endpoint Change from Baseline at Endpoint	1.5 units on a scale Standard Deviation 12.7	-3.5 units on a scale Standard Deviation 13.4	-0.7 units on a scale Standard Deviation 13.2

SECONDARY outcome

Timeframe: Baseline, Endpoint (Month 12 or last post-baseline visit)

Population: Full Analysis Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion and had data for baseline and at least 1 post-baseline assessment.

The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. The PDQ-39 Domain: Mobility (e.g., fear of falling when walking) includes 10 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.

Outcome measures

Measure	LCIG (Previous: LCIG + Placebo Capsules) n=33 Participants All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances. In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules.	LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules) n=26 Participants All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances. In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules.	LCIG (All Participants) n=59 Participants All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Mobility Domain Score at Endpoint Baseline	27.6 units on a scale Standard Deviation 24.1	43.8 units on a scale Standard Deviation 25.4	34.7 units on a scale Standard Deviation 25.8
Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Mobility Domain Score at Endpoint Change from Baseline at Endpoint	2.3 units on a scale Standard Deviation 19.5	-8.5 units on a scale Standard Deviation 18.6	-2.5 units on a scale Standard Deviation 19.7

SECONDARY outcome

Timeframe: Baseline, Endpoint (Month 12 or last post-baseline visit)

Population: Full Analysis Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion and had data for baseline and at least 1 post-baseline assessment.

The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. The PDQ-39 Domain: Activities of Daily Living (e.g., difficulty cutting food) includes 6 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.

Outcome measures

Measure	LCIG (Previous: LCIG + Placebo Capsules) n=33 Participants All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances. In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules.	LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules) n=26 Participants All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances. In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules.	LCIG (All Participants) n=59 Participants All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Activities of Daily Living Domain Score at Endpoint Baseline	25.9 units on a scale Standard Deviation 24.8	39.4 units on a scale Standard Deviation 21.3	31.9 units on a scale Standard Deviation 24.1
Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Activities of Daily Living Domain Score at Endpoint Change from Baseline at Endpoint	0.4 units on a scale Standard Deviation 14.0	-6.7 units on a scale Standard Deviation 19.9	-2.8 units on a scale Standard Deviation 17.1

SECONDARY outcome

Timeframe: Baseline, Endpoint (Month 12 or last post-baseline visit)

Population: Full Analysis Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion and had data for baseline and at least 1 post-baseline assessment.

The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. The PDQ-39 Domain: Emotional Well-being (e.g., feelings of isolation) includes 6 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.

Outcome measures

Measure	LCIG (Previous: LCIG + Placebo Capsules) n=32 Participants All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances. In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules.	LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules) n=26 Participants All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances. In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules.	LCIG (All Participants) n=58 Participants All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Emotional Well-Being Domain Score at Endpoint Baseline	20.1 units on a scale Standard Deviation 20.3	26.3 units on a scale Standard Deviation 17.2	22.8 units on a scale Standard Deviation 19.1
Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Emotional Well-Being Domain Score at Endpoint Change from Baseline at Endpoint	4.0 units on a scale Standard Deviation 16.4	1.9 units on a scale Standard Deviation 18.1	3.1 units on a scale Standard Deviation 17.1

SECONDARY outcome

Timeframe: Baseline, Endpoint (Month 12 or last post-baseline visit)

Population: Full Analysis Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion and had data for baseline and at least 1 post-baseline assessment.

The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. The PDQ-39 Domain: Stigma (e.g., social embarrassment) consists of 4 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.

Outcome measures

Measure	LCIG (Previous: LCIG + Placebo Capsules) n=32 Participants All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances. In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules.	LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules) n=26 Participants All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances. In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules.	LCIG (All Participants) n=58 Participants All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Stigma Domain Score at Endpoint Baseline	16.4 units on a scale Standard Deviation 21.3	23.8 units on a scale Standard Deviation 19.0	19.7 units on a scale Standard Deviation 20.5
Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Stigma Domain Score at Endpoint Change from Baseline at Endpoint	0.2 units on a scale Standard Deviation 15.2	-6.3 units on a scale Standard Deviation 20.7	-2.7 units on a scale Standard Deviation 18.0

SECONDARY outcome

Timeframe: Baseline, Endpoint (Month 12 or last post-baseline visit)

Population: Full Analysis Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion and had data for baseline and at least 1 post-baseline assessment.

The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. The PDQ-39 Domain: Social Support includes 3 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.

Outcome measures

Measure	LCIG (Previous: LCIG + Placebo Capsules) n=33 Participants All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances. In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules.	LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules) n=26 Participants All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances. In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules.	LCIG (All Participants) n=59 Participants All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Social Support Domain Score at Endpoint Baseline	11.9 units on a scale Standard Deviation 18.2	17.1 units on a scale Standard Deviation 17.8	14.2 units on a scale Standard Deviation 18.0
Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Social Support Domain Score at Endpoint Change from Baseline at Endpoint	1.8 units on a scale Standard Deviation 17.2	-2.7 units on a scale Standard Deviation 15.5	-0.2 units on a scale Standard Deviation 16.5

SECONDARY outcome

Timeframe: Baseline, Endpoint (Month 12 or last post-baseline visit)

Population: Full Analysis Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion and had data for baseline and at least 1 post-baseline assessment.

The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. The PDQ-39 Domain: Cognition includes 4 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.

Outcome measures

Measure	LCIG (Previous: LCIG + Placebo Capsules) n=33 Participants All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances. In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules.	LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules) n=26 Participants All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances. In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules.	LCIG (All Participants) n=59 Participants All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Cognition Domain Score at Endpoint Baseline	15.0 units on a scale Standard Deviation 14.1	24.8 units on a scale Standard Deviation 18.9	19.3 units on a scale Standard Deviation 16.9
Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Cognition Domain Score at Endpoint Change from Baseline at Endpoint	1.3 units on a scale Standard Deviation 16.3	3.8 units on a scale Standard Deviation 16.7	2.4 units on a scale Standard Deviation 16.4

SECONDARY outcome

Timeframe: Baseline, Endpoint (Month 12 or last post-baseline visit)

Population: Full Analysis Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion and had data for baseline and at least 1 post-baseline assessment.

The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. The PDQ-39 Domain: Communication includes 3 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.

Outcome measures

Measure	LCIG (Previous: LCIG + Placebo Capsules) n=33 Participants All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances. In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules.	LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules) n=26 Participants All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances. In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules.	LCIG (All Participants) n=59 Participants All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Communication Domain Score at Endpoint Baseline	15.9 units on a scale Standard Deviation 16.3	31.7 units on a scale Standard Deviation 23.2	22.9 units on a scale Standard Deviation 21.0
Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Communication Domain Score at Endpoint Change from Baseline at Endpoint	8.3 units on a scale Standard Deviation 18.4	-1.9 units on a scale Standard Deviation 15.3	3.8 units on a scale Standard Deviation 17.7

SECONDARY outcome

Timeframe: Baseline, Endpoint (Month 12 or last post-baseline visit)

Population: Full Analysis Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion and had data for baseline and at least 1 post-baseline assessment.

The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. The PDQ-39 Domain: Bodily Discomfort includes 3 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.

Outcome measures

Measure	LCIG (Previous: LCIG + Placebo Capsules) n=33 Participants All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances. In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules.	LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules) n=26 Participants All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances. In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules.	LCIG (All Participants) n=59 Participants All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Bodily Discomfort Domain Score at Endpoint Endpoint	32.1 units on a scale Standard Deviation 25.8	34.9 units on a scale Standard Deviation 22.9	33.3 units on a scale Standard Deviation 24.4
Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Bodily Discomfort Domain Score at Endpoint Change from Baseline at Endpoint	-2.8 units on a scale Standard Deviation 18.8	1.0 units on a scale Standard Deviation 19.5	-1.1 units on a scale Standard Deviation 19.0

SECONDARY outcome

Timeframe: Baseline, Endpoint (Month 12 or last post-baseline visit)

Population: Full Analysis Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion and had data for baseline and at least 1 post-baseline assessment.

The EQ-5D is a participant answered questionnaire scoring 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. EQ-5D health states, defined by the EQ-5D descriptive system, are converted into a single summary index by applying a formula that essentially attaches values (also called QOL weights or QOL utilities) to each of the levels in each dimension. EQ-5D Summary Index values range from -0.11 to 1.00 with positive change indicating improvement.

Outcome measures

Measure	LCIG (Previous: LCIG + Placebo Capsules) n=33 Participants All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances. In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules.	LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules) n=26 Participants All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances. In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules.	LCIG (All Participants) n=59 Participants All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
Change From Baseline in EuroQol Quality of Life Scale (EQ-5D) Summary Index at Endpoint Baseline	0.778 units on a scale Standard Deviation 0.144	0.676 units on a scale Standard Deviation 0.158	0.733 units on a scale Standard Deviation 0.158
Change From Baseline in EuroQol Quality of Life Scale (EQ-5D) Summary Index at Endpoint Change from Baseline at Endpoint	-0.009 units on a scale Standard Deviation 0.173	-0.006 units on a scale Standard Deviation 0.220	-0.008 units on a scale Standard Deviation 0.193

SECONDARY outcome

Timeframe: Baseline, Endpoint (Month 12 or last post-baseline visit)

Population: Full Analysis Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion and had data for baseline and at least 1 post-baseline assessment.

The EQ-5D VAS records the participant's self-rated health on a scale from 0-100 where 100 is the 'best imaginable health state' and 0 is the 'worst imaginable health state.'

Outcome measures

Measure	LCIG (Previous: LCIG + Placebo Capsules) n=33 Participants All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances. In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules.	LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules) n=26 Participants All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances. In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules.	LCIG (All Participants) n=59 Participants All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
Change From Baseline in EuroQol Quality of Life Scale (EQ-5D) Visual Analogue Scale (VAS) at Endpoint Baseline	76.7 units on a scale Standard Deviation 16.2	62.1 units on a scale Standard Deviation 22.0	70.2 units on a scale Standard Deviation 20.2
Change From Baseline in EuroQol Quality of Life Scale (EQ-5D) Visual Analogue Scale (VAS) at Endpoint Change from Baseline at Endpoint	-0.9 units on a scale Standard Deviation 15.1	4.5 units on a scale Standard Deviation 15.5	1.5 units on a scale Standard Deviation 15.4

SECONDARY outcome

Timeframe: Baseline, Endpoint (Month 12 months or last post-baseline visit)

Population: Full Analysis Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion and had data for baseline and at least 1 post-baseline assessment.

The ZBI is a 22-item questionnaire regarding the caregiver/subject relationship and evaluates the caregiver's health condition, psychological well-being, finances and social life. Each question is answered on a 5-point scale (0=never, 1=rarely, 2=sometimes, 3=quite frequently, and 4=nearly always). The caregiver burden is evaluated by the total score (range 0 to 88) obtained from the sum of the answers to the 22 questions. Higher scores are associated with a higher level of burden for the caregiver.

Outcome measures

Measure	LCIG (Previous: LCIG + Placebo Capsules) n=24 Participants All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances. In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules.	LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules) n=20 Participants All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances. In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules.	LCIG (All Participants) n=44 Participants All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
Change From Baseline in Zarit Burden Interview (ZBI) Total Score at Endpoint Baseline	22.1 units on a scale Standard Deviation 15.3	27.0 units on a scale Standard Deviation 17.2	24.3 units on a scale Standard Deviation 16.2
Change From Baseline in Zarit Burden Interview (ZBI) Total Score at Endpoint Change from Baseline at Endpoint	1.1 units on a scale Standard Deviation 9.7	-1.8 units on a scale Standard Deviation 9.0	-0.2 units on a scale Standard Deviation 9.4

Adverse Events

LCIG (Previous: LCIG + Placebo Capsules)

Serious events: 5 serious events

Other events: 29 other events

Deaths: 0 deaths

LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules)

Serious events: 9 serious events

Other events: 26 other events

Deaths: 0 deaths

LCIG (All Participants)

Serious events: 14 serious events

Other events: 55 other events

Deaths: 0 deaths

Serious adverse events

Measure	LCIG (Previous: LCIG + Placebo Capsules) n=33 participants at risk All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances. In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules.	LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules) n=29 participants at risk All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances. In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules.	LCIG (All Participants) n=62 participants at risk All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
Cardiac disorders ANGINA PECTORIS	0.00% 0/33 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	3.4% 1/29 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	1.6% 1/62 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.
Gastrointestinal disorders ABDOMINAL PAIN	3.0% 1/33 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	3.4% 1/29 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	3.2% 2/62 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.
Gastrointestinal disorders FAECALOMA	0.00% 0/33 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	3.4% 1/29 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	1.6% 1/62 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.
Gastrointestinal disorders GASTROINTESTINAL HAEMORRHAGE	3.0% 1/33 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	0.00% 0/29 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	1.6% 1/62 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.
Gastrointestinal disorders INTESTINAL ISCHAEMIA	0.00% 0/33 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	3.4% 1/29 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	1.6% 1/62 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.
Gastrointestinal disorders INTESTINAL OBSTRUCTION	3.0% 1/33 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	0.00% 0/29 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	1.6% 1/62 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.
Gastrointestinal disorders INTESTINAL PERFORATION	0.00% 0/33 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	3.4% 1/29 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	1.6% 1/62 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.
Gastrointestinal disorders PERITONITIS	0.00% 0/33 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	3.4% 1/29 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	1.6% 1/62 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.
General disorders ASTHENIA	3.0% 1/33 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	3.4% 1/29 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	3.2% 2/62 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.
General disorders COMPLICATION OF DEVICE INSERTION	3.0% 1/33 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	6.9% 2/29 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	4.8% 3/62 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.
Hepatobiliary disorders CHOLECYSTITIS	0.00% 0/33 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	3.4% 1/29 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	1.6% 1/62 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.
Infections and infestations GASTROENTERITIS	0.00% 0/33 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	3.4% 1/29 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	1.6% 1/62 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.
Infections and infestations PNEUMONIA	0.00% 0/33 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	6.9% 2/29 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	3.2% 2/62 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.
Infections and infestations SEPSIS	0.00% 0/33 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	3.4% 1/29 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	1.6% 1/62 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.
Injury, poisoning and procedural complications GASTROINTESTINAL INJURY	3.0% 1/33 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	0.00% 0/29 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	1.6% 1/62 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.
Injury, poisoning and procedural complications PROCEDURAL PAIN	0.00% 0/33 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	3.4% 1/29 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	1.6% 1/62 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.
Investigations COLONOSCOPY	0.00% 0/33 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	3.4% 1/29 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	1.6% 1/62 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.
Musculoskeletal and connective tissue disorders LUMBAR SPINAL STENOSIS	3.0% 1/33 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	0.00% 0/29 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	1.6% 1/62 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.
Musculoskeletal and connective tissue disorders MUSCLE RIGIDITY	0.00% 0/33 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	3.4% 1/29 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	1.6% 1/62 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.
Nervous system disorders SYNCOPE	0.00% 0/33 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	3.4% 1/29 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	1.6% 1/62 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.
Psychiatric disorders DELUSION	0.00% 0/33 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	3.4% 1/29 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	1.6% 1/62 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.
Psychiatric disorders HALLUCINATION	0.00% 0/33 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	3.4% 1/29 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	1.6% 1/62 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.
Psychiatric disorders HALLUCINATION, AUDITORY	0.00% 0/33 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	3.4% 1/29 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	1.6% 1/62 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.
Psychiatric disorders PARANOIA	0.00% 0/33 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	3.4% 1/29 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	1.6% 1/62 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.
Renal and urinary disorders RENAL MASS	0.00% 0/33 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	3.4% 1/29 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	1.6% 1/62 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.
Renal and urinary disorders URETHRAL STENOSIS	3.0% 1/33 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	0.00% 0/29 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	1.6% 1/62 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.
Renal and urinary disorders URINARY RETENTION	3.0% 1/33 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	0.00% 0/29 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	1.6% 1/62 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.
Reproductive system and breast disorders BENIGN PROSTATIC HYPERPLASIA	0.00% 0/33 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	3.4% 1/29 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	1.6% 1/62 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.
Respiratory, thoracic and mediastinal disorders HYPOXIA	3.0% 1/33 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	0.00% 0/29 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	1.6% 1/62 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.
Respiratory, thoracic and mediastinal disorders PNEUMONIA ASPIRATION	3.0% 1/33 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	0.00% 0/29 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	1.6% 1/62 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.
Vascular disorders HYPERTENSION	0.00% 0/33 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	3.4% 1/29 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	1.6% 1/62 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.

Other adverse events

Measure	LCIG (Previous: LCIG + Placebo Capsules) n=33 participants at risk All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances. In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules.	LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules) n=29 participants at risk All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances. In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules.	LCIG (All Participants) n=62 participants at risk All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
Gastrointestinal disorders ABDOMINAL PAIN	9.1% 3/33 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	0.00% 0/29 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	4.8% 3/62 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.
Gastrointestinal disorders CONSTIPATION	12.1% 4/33 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	17.2% 5/29 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	14.5% 9/62 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.
Gastrointestinal disorders DIARRHOEA	6.1% 2/33 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	6.9% 2/29 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	6.5% 4/62 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.
Gastrointestinal disorders NAUSEA	12.1% 4/33 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	17.2% 5/29 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	14.5% 9/62 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.
Gastrointestinal disorders SALIVARY HYPERSECRETION	0.00% 0/33 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	6.9% 2/29 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	3.2% 2/62 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.
Gastrointestinal disorders VOMITING	6.1% 2/33 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	10.3% 3/29 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	8.1% 5/62 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.
General disorders COMPLICATION OF DEVICE INSERTION	6.1% 2/33 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	0.00% 0/29 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	3.2% 2/62 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.
General disorders FATIGUE	0.00% 0/33 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	6.9% 2/29 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	3.2% 2/62 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.
General disorders OEDEMA PERIPHERAL	6.1% 2/33 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	3.4% 1/29 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	4.8% 3/62 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.
Infections and infestations POSTOPERATIVE WOUND INFECTION	15.2% 5/33 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	20.7% 6/29 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	17.7% 11/62 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.
Infections and infestations RHINITIS	0.00% 0/33 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	6.9% 2/29 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	3.2% 2/62 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.
Infections and infestations UPPER RESPIRATORY TRACT INFECTION	9.1% 3/33 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	0.00% 0/29 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	4.8% 3/62 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.
Infections and infestations URINARY TRACT INFECTION	15.2% 5/33 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	13.8% 4/29 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	14.5% 9/62 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.
Injury, poisoning and procedural complications CONTUSION	12.1% 4/33 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	3.4% 1/29 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	8.1% 5/62 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.
Injury, poisoning and procedural complications EXCORIATION	0.00% 0/33 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	6.9% 2/29 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	3.2% 2/62 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.
Injury, poisoning and procedural complications FALL	21.2% 7/33 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	20.7% 6/29 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	21.0% 13/62 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.
Injury, poisoning and procedural complications GASTROINTESTINAL STOMA COMPLICATION	0.00% 0/33 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	6.9% 2/29 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	3.2% 2/62 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.
Injury, poisoning and procedural complications INCISION SITE ERYTHEMA	21.2% 7/33 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	37.9% 11/29 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	29.0% 18/62 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.
Injury, poisoning and procedural complications LACERATION	3.0% 1/33 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	6.9% 2/29 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	4.8% 3/62 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.
Injury, poisoning and procedural complications POST PROCEDURAL DISCHARGE	9.1% 3/33 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	17.2% 5/29 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	12.9% 8/62 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.
Injury, poisoning and procedural complications POST PROCEDURAL HAEMORRHAGE	3.0% 1/33 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	6.9% 2/29 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	4.8% 3/62 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.
Injury, poisoning and procedural complications PROCEDURAL PAIN	12.1% 4/33 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	10.3% 3/29 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	11.3% 7/62 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.
Injury, poisoning and procedural complications PROCEDURAL SITE REACTION	6.1% 2/33 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	10.3% 3/29 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	8.1% 5/62 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.
Injury, poisoning and procedural complications TOOTH FRACTURE	3.0% 1/33 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	6.9% 2/29 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	4.8% 3/62 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.
Investigations BLOOD HOMOCYSTEINE INCREASED	15.2% 5/33 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	6.9% 2/29 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	11.3% 7/62 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.
Investigations VITAMIN B6 DECREASED	24.2% 8/33 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	17.2% 5/29 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	21.0% 13/62 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.
Investigations WEIGHT DECREASED	6.1% 2/33 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	10.3% 3/29 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	8.1% 5/62 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.
Investigations X-RAY ABNORMAL	6.1% 2/33 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	0.00% 0/29 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	3.2% 2/62 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.
Metabolism and nutrition disorders DECREASED APPETITE	3.0% 1/33 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	6.9% 2/29 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	4.8% 3/62 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.
Musculoskeletal and connective tissue disorders ARTHRALGIA	15.2% 5/33 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	6.9% 2/29 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	11.3% 7/62 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.
Musculoskeletal and connective tissue disorders BACK PAIN	6.1% 2/33 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	13.8% 4/29 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	9.7% 6/62 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.
Musculoskeletal and connective tissue disorders MUSCLE SPASMS	3.0% 1/33 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	6.9% 2/29 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	4.8% 3/62 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.
Musculoskeletal and connective tissue disorders NECK PAIN	0.00% 0/33 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	6.9% 2/29 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	3.2% 2/62 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.
Musculoskeletal and connective tissue disorders PAIN IN EXTREMITY	6.1% 2/33 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	10.3% 3/29 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	8.1% 5/62 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) MELANOCYTIC NAEVUS	6.1% 2/33 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	3.4% 1/29 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	4.8% 3/62 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) SEBORRHOEIC KERATOSIS	15.2% 5/33 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	10.3% 3/29 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	12.9% 8/62 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.
Nervous system disorders CARPAL TUNNEL SYNDROME	6.1% 2/33 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	0.00% 0/29 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	3.2% 2/62 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.
Nervous system disorders DISTURBANCE IN ATTENTION	6.1% 2/33 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	0.00% 0/29 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	3.2% 2/62 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.
Nervous system disorders DYSKINESIA	12.1% 4/33 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	10.3% 3/29 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	11.3% 7/62 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.
Nervous system disorders DYSTONIA	3.0% 1/33 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	13.8% 4/29 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	8.1% 5/62 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.
Nervous system disorders FREEZING PHENOMENON	12.1% 4/33 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	10.3% 3/29 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	11.3% 7/62 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.
Nervous system disorders HEADACHE	15.2% 5/33 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	3.4% 1/29 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	9.7% 6/62 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.
Nervous system disorders PARKINSON'S DISEASE	12.1% 4/33 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	13.8% 4/29 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	12.9% 8/62 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.
Nervous system disorders POLYNEUROPATHY	9.1% 3/33 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	10.3% 3/29 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	9.7% 6/62 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.
Nervous system disorders RESTLESS LEGS SYNDROME	6.1% 2/33 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	6.9% 2/29 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	6.5% 4/62 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.
Psychiatric disorders ABNORMAL DREAMS	0.00% 0/33 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	6.9% 2/29 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	3.2% 2/62 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.
Psychiatric disorders ANXIETY	9.1% 3/33 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	6.9% 2/29 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	8.1% 5/62 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.
Psychiatric disorders DEPRESSION	9.1% 3/33 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	6.9% 2/29 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	8.1% 5/62 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.
Psychiatric disorders HALLUCINATION	3.0% 1/33 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	6.9% 2/29 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	4.8% 3/62 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.
Psychiatric disorders INSOMNIA	6.1% 2/33 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	24.1% 7/29 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	14.5% 9/62 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.
Psychiatric disorders SLEEP ATTACKS	0.00% 0/33 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	10.3% 3/29 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	4.8% 3/62 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.
Renal and urinary disorders POLLAKIURIA	9.1% 3/33 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	0.00% 0/29 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	4.8% 3/62 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.
Skin and subcutaneous tissue disorders EXCESSIVE GRANULATION TISSUE	6.1% 2/33 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	13.8% 4/29 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	9.7% 6/62 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.
Skin and subcutaneous tissue disorders LENTIGO	6.1% 2/33 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	3.4% 1/29 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	4.8% 3/62 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.
Skin and subcutaneous tissue disorders RASH	0.00% 0/33 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	6.9% 2/29 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	3.2% 2/62 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.
Vascular disorders ORTHOSTATIC HYPOTENSION	9.1% 3/33 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	10.3% 3/29 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.	9.7% 6/62 • From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J (up to 52 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the first dose of study drug in this study to the end of therapy (last dose of study drug or PEG-J removal, whichever is later) plus 30 days.

Additional Information

Global Medical Services

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