Trial Outcomes & Findings for Levodopa-Carbidopa Intestinal Gel Open-Label Study in Advanced Parkinson's Disease (NCT NCT00335153)

NCT ID: NCT00335153

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: 354 participants
• Primary outcome timeframe: Screening through Day 378 + 30 days
• Results posted on: 2015-01-16

Participant Flow

Participant milestones

Measure	Levodopa-Carbidopa Intestinal Gel (LCIG) All participants were to receive levodopa-carbidopa intestinal gel (LCIG), via the nasojejunal (NJ) tube during the NJ Test Period and delivered to the proximal small intestine via percutaneous endoscopic gastrostomy with jejunal extension tube (PEG-J) during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment. The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances.
Nasojejunal (NJ) Test Period STARTED	354
Nasojejunal (NJ) Test Period COMPLETED	324
Nasojejunal (NJ) Test Period NOT COMPLETED	30
Post-PEG-J Long-Term Treatment Period STARTED	324
Post-PEG-J Long-Term Treatment Period COMPLETED	272
Post-PEG-J Long-Term Treatment Period NOT COMPLETED	52

Reasons for withdrawal

Measure	Levodopa-Carbidopa Intestinal Gel (LCIG) All participants were to receive levodopa-carbidopa intestinal gel (LCIG), via the nasojejunal (NJ) tube during the NJ Test Period and delivered to the proximal small intestine via percutaneous endoscopic gastrostomy with jejunal extension tube (PEG-J) during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment. The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances.
Nasojejunal (NJ) Test Period Adverse Event	5
Nasojejunal (NJ) Test Period Lack of Efficacy	5
Nasojejunal (NJ) Test Period Withdrawal by Subject	12
Nasojejunal (NJ) Test Period Administrative	1
Nasojejunal (NJ) Test Period Protocol Violation	7
Post-PEG-J Long-Term Treatment Period Adverse Event	22
Post-PEG-J Long-Term Treatment Period Lack of Efficacy	2
Post-PEG-J Long-Term Treatment Period Withdrawal by Subject	13
Post-PEG-J Long-Term Treatment Period Administrative	13
Post-PEG-J Long-Term Treatment Period Protocol Violation	2

Baseline Characteristics

Levodopa-Carbidopa Intestinal Gel Open-Label Study in Advanced Parkinson's Disease

Baseline characteristics by cohort

Measure	Levodopa-Carbidopa Intestinal Gel (LCIG) n=354 Participants All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment. The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances.
Age, Continuous	64.1 years STANDARD_DEVIATION 9.1 • n=5 Participants
Age, Customized <65 years	171 participants n=5 Participants
Age, Customized >=65 years	183 participants n=5 Participants
Sex: Female, Male Female	152 Participants n=5 Participants
Sex: Female, Male Male	202 Participants n=5 Participants

PRIMARY outcome

Timeframe: Screening through Day 378 + 30 days

Population: Safety Data Set: participants who were allocated to treatment, had started placement of NJ tube, and had at least 1 post-baseline safety evaluation (only participants lost to follow-up with no post-baseline information were excluded).

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	Levodopa-Carbidopa Intestinal Gel (LCIG) n=354 Participants All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment. The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances.
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations Due to AEs >=1 Severe TEAE	102 participants
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations Due to AEs Deaths	8 participants
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations Due to AEs TE Deaths	7 participants
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations Due to AEs >=1 SAE	111 participants
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations Due to AEs >=1TESAE	108 participants
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations Due to AEs >=1 TEAE Leading to Study Termination	27 participants
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations Due to AEs >=1 TEAE	323 participants
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations Due to AEs >=1 Possibly or Probably Treatment Related TEAE	272 participants
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations Due to AEs No TEAE	31 participants

PRIMARY outcome

Timeframe: NJ Test Period (from 2 to 14 days)

Population: Safety Data Set: participants who were allocated to treatment, had started placement of NJ tube, and had at least 1 post-baseline safety evaluation (only participants lost to follow-up with no post-baseline information were excluded).

Complications of the infusion device were collected during the NJ Test period. Pump, intestinal tube, NJ tube, 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 post-procedural hemorrhage.

Outcome measures

Measure	Levodopa-Carbidopa Intestinal Gel (LCIG) n=354 Participants All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment. The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances.
Number of Participants With Device Complications During the Nasojejunal (NJ) Test Period >=1 Complication	90 participants
Number of Participants With Device Complications During the Nasojejunal (NJ) Test Period Pump Complication	7 participants
Number of Participants With Device Complications During the Nasojejunal (NJ) Test Period Intestinal Tube Complication	4 participants
Number of Participants With Device Complications During the Nasojejunal (NJ) Test Period NJ Tube Complication	68 participants
Number of Participants With Device Complications During the Nasojejunal (NJ) Test Period Other Complications	25 participants

PRIMARY outcome

Timeframe: PEG-J Surgery Period (from 2 to 14 days) through the Long Term Treatment Period (Day 28 to Day 378)

Population: Post-PEG Safety Data Set: participants who continued to the PEG-J surgery, and had at least 1 post-baseline safety evaluation (only participants lost to follow-up with no post-baseline information were excluded).

Complications of the infusion device were collected during the PEG-J Surgery and Post-PEG Long-Term Treatment periods. Pump, PEG-J, 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 post-procedural hemorrhage.

Outcome measures

Measure	Levodopa-Carbidopa Intestinal Gel (LCIG) n=324 Participants All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment. The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances.
Number of Participants With Device Complications During the Percutaneous Endoscopic Gastrostomy - With Jejunal Extension Tube (PEG-J) Surgery and Post-PEG Long Term Treatment Periods >=1 Complication	282 participants
Number of Participants With Device Complications During the Percutaneous Endoscopic Gastrostomy - With Jejunal Extension Tube (PEG-J) Surgery and Post-PEG Long Term Treatment Periods Pump Complication	116 participants
Number of Participants With Device Complications During the Percutaneous Endoscopic Gastrostomy - With Jejunal Extension Tube (PEG-J) Surgery and Post-PEG Long Term Treatment Periods Intestinal Tube Complication	165 participants
Number of Participants With Device Complications During the Percutaneous Endoscopic Gastrostomy - With Jejunal Extension Tube (PEG-J) Surgery and Post-PEG Long Term Treatment Periods PEG-J Complication	114 participants
Number of Participants With Device Complications During the Percutaneous Endoscopic Gastrostomy - With Jejunal Extension Tube (PEG-J) Surgery and Post-PEG Long Term Treatment Periods Stoma Complication	116 participants
Number of Participants With Device Complications During the Percutaneous Endoscopic Gastrostomy - With Jejunal Extension Tube (PEG-J) Surgery and Post-PEG Long Term Treatment Periods Other Complication	114 participants

PRIMARY outcome

Timeframe: Screening through Day 378

Population: Post-PEG Safety Data Set: participants who continued to the PEG-J surgery, and had at least 1 post-baseline safety evaluation (only participants lost to follow-up with no post-baseline information were excluded); n=number of participants with assessment.

Potentially clinically significant values for red blood cells (RBCs), hemoglobin, and hematocrit are specified for females (f) and males (m) separately in the category rows.

Outcome measures

Measure	Levodopa-Carbidopa Intestinal Gel (LCIG) n=324 Participants All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment. The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 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 RBCs <2.0*10^12/L (f), <2.5*10^12/L (m); n=316	0 participants
Number of Participants With Potentially Clinically Significant Values for Hematology Parameters Hemoglobin <90 g/L (f), <100 g/L (m); n=316	4 participants
Number of Participants With Potentially Clinically Significant Values for Hematology Parameters Hematocrit <30% (f), <34% (m); n=315	27 participants
Number of Participants With Potentially Clinically Significant Values for Hematology Parameters White Blood Cells <2.8*10^9/L; n=316	3 participants
Number of Participants With Potentially Clinically Significant Values for Hematology Parameters White Blood Cells >16.0*10^9/L; n=316	0 participants
Number of Participants With Potentially Clinically Significant Values for Hematology Parameters Neutrophils <1.2*10^9/L; n=316	0 participants
Number of Participants With Potentially Clinically Significant Values for Hematology Parameters Lymphocytes <0.75*10^9/L; n=316	21 participants
Number of Participants With Potentially Clinically Significant Values for Hematology Parameters Lymphocytes >80%; n=316	0 participants
Number of Participants With Potentially Clinically Significant Values for Hematology Parameters Platelet Count <95*10^9/L; n=315	1 participants
Number of Participants With Potentially Clinically Significant Values for Hematology Parameters Platelet Count >700*10^9/L; n=315	0 participants
Number of Participants With Potentially Clinically Significant Values for Hematology Parameters Mean Corpuscular Volume <60 fL; n=315	0 participants
Number of Participants With Potentially Clinically Significant Values for Hematology Parameters Mean Corpuscular Volume >120 fL; n=315	0 participants
Number of Participants With Potentially Clinically Significant Values for Hematology Parameters Eosinophils >10%; n=316	7 participants
Number of Participants With Potentially Clinically Significant Values for Hematology Parameters Monocytes >30%; n=316	0 participants

PRIMARY outcome

Timeframe: Screening through Day 378

Population: Post-PEG Safety Data Set: participants who continued to the PEG-J surgery, and had at least 1 post-baseline safety evaluation (only participants lost to follow-up with no post-baseline information were excluded); n=number of participants with assessment.

Terms abbreviated in the table include aspartate aminotransferase (AST), upper limit of normal (ULN), alanine aminotransferase (ALT), gamma-glutamyl transpeptidase (GGT), lactate dehydrogenase (LDH), blood urea nitrogen (BUN), female (f), and male (m).

Outcome measures

Measure	Levodopa-Carbidopa Intestinal Gel (LCIG) n=324 Participants All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment. The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 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 <1.75 mmol/L; n=315	2 participants
Number of Participants With Potentially Clinically Significant Values for Clinical Chemistry Parameters AST >3*ULN; n=315	1 participants
Number of Participants With Potentially Clinically Significant Values for Clinical Chemistry Parameters ALT >3*ULN; n=315	0 participants
Number of Participants With Potentially Clinically Significant Values for Clinical Chemistry Parameters GGT >3*ULN; n=315	3 participants
Number of Participants With Potentially Clinically Significant Values for Clinical Chemistry Parameters LDH >3*ULN; n=315	0 participants
Number of Participants With Potentially Clinically Significant Values for Clinical Chemistry Parameters Alkaline Phosphatase >400 U/L; n=315	0 participants
Number of Participants With Potentially Clinically Significant Values for Clinical Chemistry Parameters Total Protein <45 g/L; n=315	0 participants
Number of Participants With Potentially Clinically Significant Values for Clinical Chemistry Parameters Total Bilirubin >2*ULN; n=315	0 participants
Number of Participants With Potentially Clinically Significant Values for Clinical Chemistry Parameters Creatine Kinase >3*ULN; n=315	7 participants
Number of Participants With Potentially Clinically Significant Values for Clinical Chemistry Parameters Sodium <126 mmol/L; n=315	2 participants
Number of Participants With Potentially Clinically Significant Values for Clinical Chemistry Parameters Sodium >156 mmol/L; n=315	2 participants
Number of Participants With Potentially Clinically Significant Values for Clinical Chemistry Parameters Potassium <3.0 mmol/L; n=315	1 participants
Number of Participants With Potentially Clinically Significant Values for Clinical Chemistry Parameters Potassium >6.0 mmol/L; n=315	1 participants
Number of Participants With Potentially Clinically Significant Values for Clinical Chemistry Parameters Calcium >3.0 mmol/L; n=315	0 participants
Number of Participants With Potentially Clinically Significant Values for Clinical Chemistry Parameters BUN >10.8 mmol/L; n=77	4 participants
Number of Participants With Potentially Clinically Significant Values for Clinical Chemistry Parameters Creatinine >177 mcmol/L; n=315	3 participants
Number of Participants With Potentially Clinically Significant Values for Clinical Chemistry Parameters Uric Acid >500 mcmol/L (f), >590 mcmol/L (m);n=315	0 participants
Number of Participants With Potentially Clinically Significant Values for Clinical Chemistry Parameters Glucose (nonfasting) <2.78 mmol/L; n=315	1 participants
Number of Participants With Potentially Clinically Significant Values for Clinical Chemistry Parameters Glucose (nonfasting) >16.0 mmol/L; n=315	1 participants
Number of Participants With Potentially Clinically Significant Values for Clinical Chemistry Parameters Cholesterol >12.9 mmol/L; n=315	0 participants
Number of Participants With Potentially Clinically Significant Values for Clinical Chemistry Parameters Triglycerides >5.6 mmol/L; n=315	2 participants

PRIMARY outcome

Timeframe: up to 56 weeks

Population: Post-PEG Safety Data Set: participants who continued to the PEG-J surgery, and had at least 1 post-baseline safety evaluation (only participants lost to follow-up with no post-baseline information were excluded); 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	Levodopa-Carbidopa Intestinal Gel (LCIG) n=324 Participants All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment. The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 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 >=180 and >40 mm Hg ↑ from BL; n=324	4 participants
Number of Participants With Potentially Clinically Significant Vital Sign Parameters SuSBP <=90 and >30 mm Hg ↓ from BL; n=324	17 participants
Number of Participants With Potentially Clinically Significant Vital Sign Parameters StSBP >=180 and >40 mm Hg ↑ from BL; n=324	2 participants
Number of Participants With Potentially Clinically Significant Vital Sign Parameters StSBP <=90 and >30 mm Hg ↓ from BL; n=324	35 participants
Number of Participants With Potentially Clinically Significant Vital Sign Parameters OSBP: ↓ >=30 mm Hg (Supine to Standing); n=324	80 participants
Number of Participants With Potentially Clinically Significant Vital Sign Parameters SuDBP >=105 and >30 mm Hg ↑ from BL; n=324	5 participants
Number of Participants With Potentially Clinically Significant Vital Sign Parameters SuDBP <=50 and >30 mm Hg ↓ from BL; n=324	11 participants
Number of Participants With Potentially Clinically Significant Vital Sign Parameters StDBP >=105 and >30 mm Hg ↑ from BL; n=324	8 participants
Number of Participants With Potentially Clinically Significant Vital Sign Parameters StDBP <=50 and >30 mm Hg ↓ from BL; n=324	12 participants
Number of Participants With Potentially Clinically Significant Vital Sign Parameters ODBP: ↓ >=20 mm Hg (Supine to Standing); n=324	59 participants
Number of Participants With Potentially Clinically Significant Vital Sign Parameters SuP >=120 and >30 bpm ↑ from BL; n=324	0 participants
Number of Participants With Potentially Clinically Significant Vital Sign Parameters SuP <=50 and >30 bpm ↓ from BL; n=324	1 participants
Number of Participants With Potentially Clinically Significant Vital Sign Parameters StP >=120 and >30 bpm ↑ from BL; n=324	0 participants
Number of Participants With Potentially Clinically Significant Vital Sign Parameters StP <=50 and >30 bpm ↓ from BL; n=324	0 participants
Number of Participants With Potentially Clinically Significant Vital Sign Parameters Temp >=38.3 and >1.1°C ↑ from BL; n=322	2 participants
Number of Participants With Potentially Clinically Significant Vital Sign Parameters Weight >=7% ↑ from BL; n=272	25 participants
Number of Participants With Potentially Clinically Significant Vital Sign Parameters Weight <=7% ↓ from BL; n=272	79 participants

PRIMARY outcome

Timeframe: Screening through Day 378

Population: Post-PEG Safety Data Set: participants who continued to the PEG-J surgery, and had at least 1 post-baseline safety evaluation (only participants lost to follow-up with no post-baseline information were excluded); n=number of participants with given assessment.

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	Levodopa-Carbidopa Intestinal Gel (LCIG) n=324 Participants All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment. The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 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 PR Interval >220 msec; n=321	26 participants
Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Parameters QTcB Interval >480 msec; n=319	15 participants
Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Parameters QTcF Interval >480 msec; n=319	7 participants
Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Parameters HR <=50 and >30 bpm ↓ from BL; n=321	1 participants
Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Parameters HR >=120 and >30 bpm ↑ from BL; n=321	1 participants
Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Parameters PR Interval <120 msec; n=321	6 participants
Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Parameters QTcB Interval >60 msec ↑ from BL; n=309	4 participants
Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Parameters QTcF Interval >60 msec ↑ from BL; n=309	3 participants

PRIMARY outcome

Timeframe: Baseline

Population: Post-PEG Safety Data Set: participants who continued to the PEG-J surgery, and had at least 1 post-baseline safety evaluation (only participants lost to follow-up with no post-baseline information were excluded).

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. Those participants who reported 1 or more sleep attacks were asked to report the number of sleep attacks they experienced, whether they experienced sleepiness or drowsiness prior to the sleep attack, whether they experienced a 'bad' outcome or problem due to a sleep attack, and if so, how many 'bad' outcomes or problems they experienced.

Outcome measures

Measure	Levodopa-Carbidopa Intestinal Gel (LCIG) n=324 Participants All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment. The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances.
Number of Participants With Sleep Attacks at Baseline Number of Sleep Attacks Per Participant=2	0 participants
Number of Participants With Sleep Attacks at Baseline Participants with >=1 Sleep Attacks	7 participants
Number of Participants With Sleep Attacks at Baseline Number of Sleep Attacks Per Participant=1	4 participants
Number of Participants With Sleep Attacks at Baseline Number of Sleep Attacks Per Participant=3	0 participants
Number of Participants With Sleep Attacks at Baseline Number of Sleep Attacks Per Participant>3	2 participants
Number of Participants With Sleep Attacks at Baseline Number of Sleep Attacks Per Participant=Missing	1 participants
Number of Participants With Sleep Attacks at Baseline Sleepiness/Drowsiness Prior to Sleep Attack	4 participants
Number of Participants With Sleep Attacks at Baseline Bad Outcome/Problem Due to Sleep Attack	1 participants
Number of Participants With Sleep Attacks at Baseline Number of Bad Outcomes/Problems=1	1 participants
Number of Participants With Sleep Attacks at Baseline Number of Bad Outcomes/Problems=2	0 participants
Number of Participants With Sleep Attacks at Baseline Number of Bad Outcomes/Problems=3	0 participants
Number of Participants With Sleep Attacks at Baseline Number of Bad Outcomes/Problems>3	0 participants

PRIMARY outcome

Timeframe: During the Post-PEG Long-Term Treatment Period (Day 28 through Day 378)

Population: Post-PEG Safety Data Set: participants who continued to the PEG-J surgery, and had at least 1 post-baseline safety evaluation (only participants lost to follow-up with no post-baseline information were excluded) who had an assessment.

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. Those participants who reported 1 or more sleep attacks were asked to report the number of sleep attacks they experienced, whether they experienced sleepiness or drowsiness prior to the sleep attack, whether they experienced a 'bad' outcome or problem due to a sleep attack, and if so, how many 'bad' outcomes or problems they experienced.

Outcome measures

Measure	Levodopa-Carbidopa Intestinal Gel (LCIG) n=321 Participants All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment. The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances.
Number of Participants With Sleep Attacks During the Post-PEG Long-Term Treatment Period Number of Sleep Attacks Per Participant=2	2 participants
Number of Participants With Sleep Attacks During the Post-PEG Long-Term Treatment Period Number of Sleep Attacks Per Participant=3	5 participants
Number of Participants With Sleep Attacks During the Post-PEG Long-Term Treatment Period Participants with >=1 Sleep Attacks	27 participants
Number of Participants With Sleep Attacks During the Post-PEG Long-Term Treatment Period Number of Sleep Attacks Per Participant=1	11 participants
Number of Participants With Sleep Attacks During the Post-PEG Long-Term Treatment Period Number of Sleep Attacks Per Participant>3	9 participants
Number of Participants With Sleep Attacks During the Post-PEG Long-Term Treatment Period Sleepiness/Drowsiness Prior to Sleep Attack	11 participants
Number of Participants With Sleep Attacks During the Post-PEG Long-Term Treatment Period Bad Outcome/Problem Due to Sleep Attack	2 participants
Number of Participants With Sleep Attacks During the Post-PEG Long-Term Treatment Period Number of Bad Outcomes/Problems=1	2 participants
Number of Participants With Sleep Attacks During the Post-PEG Long-Term Treatment Period Number of Bad Outcomes/Problems=2	0 participants
Number of Participants With Sleep Attacks During the Post-PEG Long-Term Treatment Period Number of Bad Outcomes/Problems=3	0 participants
Number of Participants With Sleep Attacks During the Post-PEG Long-Term Treatment Period Number of Bad Outcomes/Problems>3	0 participants

PRIMARY outcome

Timeframe: Baseline, during the Post-PEG Long-term Treatment Period (Day 28 through Day 378)

Population: Post-PEG Safety Data Set: participants who continued to the PEG-J surgery, and had at least 1 post-baseline safety evaluation (only participants lost to follow-up with no post-baseline information were excluded); n=number of participants with an 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	Levodopa-Carbidopa Intestinal Gel (LCIG) n=324 Participants All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment. The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 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 During the Post-PEG Long-term Treatment (PPLT) Period BL Compulsive Buying; n=322	0 participants
Summary of Minnesota Impulsive Disorder Interview (MIDI) Assessment of Intense Impulsive Behavior at Baseline (BL) and During the Post-PEG Long-term Treatment (PPLT) Period BL Kleptomania; n=322	0 participants
Summary of Minnesota Impulsive Disorder Interview (MIDI) Assessment of Intense Impulsive Behavior at Baseline (BL) and During the Post-PEG Long-term Treatment (PPLT) Period BL Trichotillomania; n=322	0 participants
Summary of Minnesota Impulsive Disorder Interview (MIDI) Assessment of Intense Impulsive Behavior at Baseline (BL) and During the Post-PEG Long-term Treatment (PPLT) Period BL Intermittent Explosive Disorder; n=322	0 participants
Summary of Minnesota Impulsive Disorder Interview (MIDI) Assessment of Intense Impulsive Behavior at Baseline (BL) and During the Post-PEG Long-term Treatment (PPLT) Period BL Pyromania; n=322	0 participants
Summary of Minnesota Impulsive Disorder Interview (MIDI) Assessment of Intense Impulsive Behavior at Baseline (BL) and During the Post-PEG Long-term Treatment (PPLT) Period BL Pathological Gambling; n=322	2 participants
Summary of Minnesota Impulsive Disorder Interview (MIDI) Assessment of Intense Impulsive Behavior at Baseline (BL) and During the Post-PEG Long-term Treatment (PPLT) Period BL Compulsive Sexual Behavior; n=322	9 participants
Summary of Minnesota Impulsive Disorder Interview (MIDI) Assessment of Intense Impulsive Behavior at Baseline (BL) and During the Post-PEG Long-term Treatment (PPLT) Period PPLT Compulsive Buying; n=318	3 participants
Summary of Minnesota Impulsive Disorder Interview (MIDI) Assessment of Intense Impulsive Behavior at Baseline (BL) and During the Post-PEG Long-term Treatment (PPLT) Period PPLT Kleptomania; n=318	0 participants
Summary of Minnesota Impulsive Disorder Interview (MIDI) Assessment of Intense Impulsive Behavior at Baseline (BL) and During the Post-PEG Long-term Treatment (PPLT) Period PPLT Trichotillomania; n=318	0 participants
Summary of Minnesota Impulsive Disorder Interview (MIDI) Assessment of Intense Impulsive Behavior at Baseline (BL) and During the Post-PEG Long-term Treatment (PPLT) Period PPLT Intermittent Explosive Disorder; n=318	0 participants
Summary of Minnesota Impulsive Disorder Interview (MIDI) Assessment of Intense Impulsive Behavior at Baseline (BL) and During the Post-PEG Long-term Treatment (PPLT) Period PPLT Pyromania; n=318	0 participants
Summary of Minnesota Impulsive Disorder Interview (MIDI) Assessment of Intense Impulsive Behavior at Baseline (BL) and During the Post-PEG Long-term Treatment (PPLT) Period PPLT Pathological Gambling; n=318	6 participants
Summary of Minnesota Impulsive Disorder Interview (MIDI) Assessment of Intense Impulsive Behavior at Baseline (BL) and During the Post-PEG Long-term Treatment (PPLT) Period PPLT Compulsive Sexual Behavior; n=318	11 participants

PRIMARY outcome

Timeframe: Baseline, Endpoint (last Post-PEG Long-Term Period visit up to Day 378)

Population: Post-PEG Safety Data Set: participants who continued to the PEG-J surgery, and had at least 1 post-baseline safety evaluation (only participants lost to follow-up with no post-baseline information were excluded); 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 regarding issues 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	Levodopa-Carbidopa Intestinal Gel (LCIG) n=324 Participants All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment. The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 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=318	9.6 units on a scale Standard Deviation 8.1
Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score at Endpoint Change from Baseline at Endpoint; n=317	-1.7 units on a scale Standard Deviation 9.0

PRIMARY outcome

Timeframe: Screening up to Day 378

Population: Safety Data Set: participants who were allocated to treatment, had started placement of NJ tube, and had at least 1 post-baseline safety evaluation (only participants lost to follow-up with no post-baseline information were excluded).

A comprehensive assessment for the presence of melanoma was performed during the screening period and at early termination or 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

Levodopa-Carbidopa Intestinal Gel (LCIG) n=354 Participants All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment. The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 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

PRIMARY outcome

Timeframe: Screening up to Day 378

Population: Safety Data Set: participants who were allocated to treatment, had started placement of NJ tube, and had at least 1 post-baseline safety evaluation (only participants lost to follow-up with no post-baseline information were excluded).

Concomitant medications include those 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

Levodopa-Carbidopa Intestinal Gel (LCIG) n=354 Participants All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment. The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 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

349 participants

SECONDARY outcome

Timeframe: Baseline, Endpoint (last post-baseline visit up to Day 378)

Population: Full Analysis Data Set: participants who had at least 1 post-baseline safety evaluation, a baseline efficacy evaluation, and had data for at least 1 post-baseline assessment of this efficacy measurement during the Post-PEG Long-Term Treatment Period.

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	Levodopa-Carbidopa Intestinal Gel (LCIG) n=307 Participants All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment. The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 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	6.77 hours Standard Deviation 2.37
Change From Baseline in Average Daily "Off" Time at Endpoint Change from Baseline at Endpoint	-4.44 hours Standard Deviation 2.89

SECONDARY outcome

Timeframe: Baseline, Endpoint (last post-baseline visit up to Day 378)

Population: Full Analysis Data Set: participants who had at least 1 post-baseline safety evaluation, a baseline efficacy evaluation, and had data for at least 1 post-baseline assessment of this efficacy measurement during the Post-PEG Long-Term Treatment Period.

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	Levodopa-Carbidopa Intestinal Gel (LCIG) n=307 Participants All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment. The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 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	1.60 hours Standard Deviation 2.03
Change From Baseline in Average Daily Normalized "On" Time With Troublesome Dyskinesia at Endpoint Change from Baseline at Endpoint	-0.36 hours Standard Deviation 2.77

SECONDARY outcome

Timeframe: Baseline, Endpoint (last post-baseline visit up to Day 378)

Population: Full Analysis Data Set: participants who had at least 1 post-baseline safety evaluation, a baseline efficacy evaluation, and had data for at least 1 post-baseline assessment of this efficacy measurement during the Post-PEG Long-Term Treatment Period.

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	Levodopa-Carbidopa Intestinal Gel (LCIG) n=307 Participants All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment. The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 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 Endpoint Baseline	4.83 hours Standard Deviation 2.72
Change From Baseline in Average Daily "On" Time Without Troublesome Dyskinesia at Endpoint Change from Baseline at Endpoint	3.86 hours Standard Deviation 4.65

SECONDARY outcome

Timeframe: Baseline, Endpoint (last post-baseline visit up to Day 378)

Population: Full Analysis Data Set: participants who had at least 1 post-baseline safety evaluation, a baseline efficacy evaluation, and had data for at least 1 post-baseline assessment of this efficacy measurement during the Post-PEG Long-Term Treatment Period.

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	Levodopa-Carbidopa Intestinal Gel (LCIG) n=316 Participants All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment. The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 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 Baseline	4.85 units on a scale Standard Deviation 0.84
Clinical Global Impression - Status (CGI-S) Score at Baseline and Clinical Global Impression - Improvement (CGI-I) Score at Endpoint CGI-I at Endpoint	2.10 units on a scale Standard Deviation 0.95

SECONDARY outcome

Timeframe: Baseline, Endpoint (last post-baseline visit up to Day 378)

Population: Full Analysis Data Set: participants who had at least 1 post-baseline safety evaluation, a baseline efficacy evaluation, and had data for at least 1 post-baseline assessment of this efficacy measurement during the Post-PEG Long-Term Treatment Period.

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	Levodopa-Carbidopa Intestinal Gel (LCIG) n=288 Participants All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment. The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 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 Month 12 Change from Baseline at Endpoint	0.0 units on a scale Standard Deviation 1.8
Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part I Score at Month 12 Baseline	2.2 units on a scale Standard Deviation 1.9

SECONDARY outcome

Timeframe: Baseline, Endpoint (last post-baseline visit up to Day 378)

Population: Full Analysis Data Set: participants who had at least 1 post-baseline safety evaluation, a baseline efficacy evaluation, and had data for at least 1 post-baseline assessment of this efficacy measurement during the Post-PEG Long-Term Treatment Period.

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	Levodopa-Carbidopa Intestinal Gel (LCIG) n=288 Participants All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment. The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 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	17.5 units on a scale Standard Deviation 6.7
Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part II Score at Endpoint Change from Baseline at Endpoint	-4.4 units on a scale Standard Deviation 6.5

SECONDARY outcome

Timeframe: Baseline, Endpoint (last post-baseline visit up to Day 378)

Population: Full Analysis Data Set: participants who had at least 1 post-baseline safety evaluation, a baseline efficacy evaluation, and had data for at least 1 post-baseline assessment of this efficacy measurement during the Post-PEG Long-Term Treatment Period.

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	Levodopa-Carbidopa Intestinal Gel (LCIG) n=286 Participants All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment. The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 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	28.9 units on a scale Standard Deviation 13.7
Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Score at Endpoint Change from Baseline at Endpoint	-7.4 units on a scale Standard Deviation 13.2

SECONDARY outcome

Timeframe: Baseline, Endpoint (last post-baseline visit up to Day 378)

Population: Full Analysis Data Set: participants who had at least 1 post-baseline safety evaluation, a baseline efficacy evaluation, and had data for at least 1 post-baseline assessment of this efficacy measurement during the Post-PEG Long-Term Treatment Period.

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	Levodopa-Carbidopa Intestinal Gel (LCIG) n=287 Participants All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment. The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 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	48.6 units on a scale Standard Deviation 18.9
Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Total Score at Endpoint Change from Baseline at Endpoint	-11.7 units on a scale Standard Deviation 18.3

SECONDARY outcome

Timeframe: Baseline, Endpoint (last post-baseline visit up to Day 378)

Population: Full Analysis Data Set: participants who had at least 1 post-baseline safety evaluation, a baseline efficacy evaluation, and had data for at least 1 post-baseline assessment of this efficacy measurement during the Post-PEG Long-Term Treatment Period.

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	Levodopa-Carbidopa Intestinal Gel (LCIG) n=287 Participants All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment. The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 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	9.2 units on a scale Standard Deviation 2.9
Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part IV Score at Endpoint Change from Baseline at Endpoint	-3.5 units on a scale Standard Deviation 3.5

SECONDARY outcome

Timeframe: Baseline, Endpoint (last post-baseline visit up to Day 378)

Population: Full Analysis Data Set: participants who had at least 1 post-baseline safety evaluation, a baseline efficacy evaluation, and had data for at least 1 post-baseline assessment of this efficacy measurement during the Post-PEG Long-Term Treatment Period.

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	Levodopa-Carbidopa Intestinal Gel (LCIG) n=317 Participants All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment. The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 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	42.7 units on a scale Standard Deviation 15.0
Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Summary Index at Endpoint Change from Baseline at Endpoint	-6.9 units on a scale Standard Deviation 14.1

SECONDARY outcome

Timeframe: Baseline, Endpoint (last post-baseline visit up to Day 378)

Population: Full Analysis Data Set: participants who had at least 1 post-baseline safety evaluation, a baseline efficacy evaluation, and had data for at least 1 post-baseline assessment of this efficacy measurement during the Post-PEG Long-Term Treatment Period.

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	Levodopa-Carbidopa Intestinal Gel (LCIG) n=317 Participants All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment. The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 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	58.8 units on a scale Standard Deviation 22.8
Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Mobility Domain Score at Endpoint Change from Baseline at Endpoint	-11.2 units on a scale Standard Deviation 23.4

SECONDARY outcome

Timeframe: Baseline, Endpoint (last post-baseline visit up to Day 378)

Population: Full Analysis Data Set: participants who had at least 1 post-baseline safety evaluation, a baseline efficacy evaluation, and had data for at least 1 post-baseline assessment of this efficacy measurement during the Post-PEG Long-Term Treatment Period.

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	Levodopa-Carbidopa Intestinal Gel (LCIG) n=317 Participants All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment. The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 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	50.7 units on a scale Standard Deviation 22.3
Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Activities of Daily Living Domain Score at Endpoint Change from Baseline at Endpoint	-8.3 units on a scale Standard Deviation 22.6

SECONDARY outcome

Timeframe: Baseline, Endpoint (last post-baseline visit up to Day 378)

Population: Full Analysis Data Set: participants who had at least 1 post-baseline safety evaluation, a baseline efficacy evaluation, and had data for at least 1 post-baseline assessment of this efficacy measurement during the Post-PEG Long-Term Treatment Period.

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	Levodopa-Carbidopa Intestinal Gel (LCIG) n=317 Participants All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment. The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 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	39.4 units on a scale Standard Deviation 21.8
Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Emotional Well-Being Domain Score at Endpoint Change from Baseline at Endpoint	-4.2 units on a scale Standard Deviation 19.7

SECONDARY outcome

Timeframe: Baseline, Endpoint (last post-baseline visit up to Day 378)

Population: Full Analysis Data Set: participants who had at least 1 post-baseline safety evaluation, a baseline efficacy evaluation, and had data for at least 1 post-baseline assessment of this efficacy measurement during the Post-PEG Long-Term Treatment Period.

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	Levodopa-Carbidopa Intestinal Gel (LCIG) n=317 Participants All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment. The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 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	32.5 units on a scale Standard Deviation 26.0
Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Stigma Domain Score at Endpoint CHange from Baseline at Endpoint	-9.1 units on a scale Standard Deviation 22.1

SECONDARY outcome

Timeframe: Baseline, Endpoint (last post-baseline visit up to Day 378)

Population: Full Analysis Data Set: participants who had at least 1 post-baseline safety evaluation, a baseline efficacy evaluation, and had data for at least 1 post-baseline assessment of this efficacy measurement during the Post-PEG Long-Term Treatment Period.

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	Levodopa-Carbidopa Intestinal Gel (LCIG) n=315 Participants All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment. The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 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	17.2 units on a scale Standard Deviation 19.7
Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Social Support Domain Score at Endpoint Change from Baseline at Endpoint	-0.3 units on a scale Standard Deviation 18.9

SECONDARY outcome

Timeframe: Baseline, Endpoint (last post-baseline visit up to Day 378)

Population: Full Analysis Data Set: participants who had at least 1 post-baseline safety evaluation, a baseline efficacy evaluation, and had data for at least 1 post-baseline assessment of this efficacy measurement during the Post-PEG Long-Term Treatment Period.

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	Levodopa-Carbidopa Intestinal Gel (LCIG) n=317 Participants All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment. The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 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	27.2 units on a scale Standard Deviation 18.6
Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Cognition Domain Score at Endpoint Change from Baseline to Endpoint	-4.5 units on a scale Standard Deviation 18.0

SECONDARY outcome

Timeframe: Baseline, Endpoint (last post-baseline visit up to Day 378)

Population: Full Analysis Data Set: participants who had at least 1 post-baseline safety evaluation, a baseline efficacy evaluation, and had data for at least 1 post-baseline assessment of this efficacy measurement during the Post-PEG Long-Term Treatment Period.

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	Levodopa-Carbidopa Intestinal Gel (LCIG) n=317 Participants All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment. The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 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	34.3 units on a scale Standard Deviation 20.4
Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Communication Domain Score at Endpoint Change from Baseline at Endpoint	-3.9 units on a scale Standard Deviation 19.4

SECONDARY outcome

Timeframe: Baseline, Endpoint (last post-baseline visit up to Day 378)

Population: Full Analysis Data Set: participants who had at least 1 post-baseline safety evaluation, a baseline efficacy evaluation, and had data for at least 1 post-baseline assessment of this efficacy measurement during the Post-PEG Long-Term Treatment Period.

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	Levodopa-Carbidopa Intestinal Gel (LCIG) n=317 Participants All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment. The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 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 Baseline	46.2 units on a scale Standard Deviation 22.9
Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Bodily Discomfort Domain Score at Endpoint Change from Baseline at Endpoint	-5.8 units on a scale Standard Deviation 22.4

SECONDARY outcome

Timeframe: Baseline, Endpoint (last post-baseline visit up to Day 378)

Population: Full Analysis Data Set: participants who had at least 1 post-baseline safety evaluation, a baseline efficacy evaluation, and had data for at least 1 post-baseline assessment of this efficacy measurement during the Post-PEG Long-Term Treatment Period.

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	Levodopa-Carbidopa Intestinal Gel (LCIG) n=313 Participants All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment. The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 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	0.588 units on a scale Standard Deviation 0.195
Change From Baseline in EuroQol Quality of Life Scale (EQ-5D) Summary Index at Endpoint Change from Baseline at Endpoint	0.064 units on a scale Standard Deviation 0.203

SECONDARY outcome

Timeframe: Baseline, Endpoint (last post-baseline visit up to Day 378)

Population: Full Analysis Data Set: participants who had at least 1 post-baseline safety evaluation, a baseline efficacy evaluation, and had data for at least 1 post-baseline assessment of this efficacy measurement during the Post-PEG Long-Term Treatment Period.

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	Levodopa-Carbidopa Intestinal Gel (LCIG) n=313 Participants All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment. The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 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	50.2 units on a scale Standard Deviation 21.0
Change From Baseline in EuroQol Quality of Life Scale (EQ-5D) Visual Analogue Scale (VAS) at Endpoint Change from Baseline at Endpoint	14.0 units on a scale Standard Deviation 24.8

SECONDARY outcome

Timeframe: Baseline, Endpoint (last post-baseline visit up to Day 378)

Population: Full Analysis Data Set: participants who had at least 1 post-baseline safety evaluation, a baseline efficacy evaluation, and had data for at least 1 post-baseline assessment of this efficacy measurement during the Post-PEG Long-Term Treatment Period.

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	Levodopa-Carbidopa Intestinal Gel (LCIG) n=172 Participants All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment. The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 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	27.1 units on a scale Standard Deviation 13.2
Change From Baseline in Zarit Burden Interview (ZBI) Total Score at Endpoint Change from Baseline at Endpoint	0.2 units on a scale Standard Deviation 10.8

Adverse Events

Levodopa-Carbidopa Intestinal Gel (LCIG)

Serious events: 108 serious events

Other events: 278 other events

Deaths: 0 deaths

Serious adverse events

Measure	Levodopa-Carbidopa Intestinal Gel (LCIG) n=354 participants at risk All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment. The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances.
Blood and lymphatic system disorders ANAEMIA	0.56% 2/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Blood and lymphatic system disorders ANAEMIA VITAMIN B12 DEFICIENCY	0.28% 1/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Blood and lymphatic system disorders LEUKOCYTOSIS	0.28% 1/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Cardiac disorders ATRIOVENTRICULAR BLOCK SECOND DEGREE	0.28% 1/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Cardiac disorders MYOCARDIAL INFARCTION	0.28% 1/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Endocrine disorders SECONDARY ADRENOCORTICAL INSUFFICIENCY	0.28% 1/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Eye disorders ANGLE CLOSURE GLAUCOMA	0.28% 1/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Eye disorders CATARACT	0.28% 1/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Eye disorders OPTIC ISCHAEMIC NEUROPATHY	0.28% 1/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Gastrointestinal disorders ABDOMINAL PAIN	2.8% 10/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Gastrointestinal disorders ABDOMINAL PAIN UPPER	0.28% 1/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Gastrointestinal disorders ACUTE ABDOMEN	0.56% 2/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Gastrointestinal disorders BEZOAR	0.28% 1/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Gastrointestinal disorders COLONIC POLYP	0.28% 1/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Gastrointestinal disorders CONSTIPATION	0.56% 2/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Gastrointestinal disorders DUODENAL PERFORATION	0.28% 1/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Gastrointestinal disorders DYSPHAGIA	0.28% 1/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Gastrointestinal disorders FAECALOMA	0.28% 1/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Gastrointestinal disorders FLATULENCE	0.28% 1/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Gastrointestinal disorders GASTRIC HYPOMOTILITY	0.28% 1/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Gastrointestinal disorders GASTRITIS	0.28% 1/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Gastrointestinal disorders HAEMORRHOIDAL HAEMORRHAGE	0.28% 1/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Gastrointestinal disorders ILEUS PARALYTIC	0.28% 1/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Gastrointestinal disorders INGUINAL HERNIA	0.28% 1/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Gastrointestinal disorders INGUINAL HERNIA, OBSTRUCTIVE	0.28% 1/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Gastrointestinal disorders INTESTINAL HAEMATOMA	0.28% 1/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Gastrointestinal disorders INTESTINAL INFARCTION	0.28% 1/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Gastrointestinal disorders INTESTINAL PERFORATION	0.28% 1/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Gastrointestinal disorders INTESTINAL STENOSIS	0.28% 1/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Gastrointestinal disorders LARGE INTESTINE PERFORATION	0.28% 1/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Gastrointestinal disorders NAUSEA	0.56% 2/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Gastrointestinal disorders PANCREATITIS	0.28% 1/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Gastrointestinal disorders PERITONITIS	2.5% 9/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Gastrointestinal disorders PNEUMATOSIS INTESTINALIS	0.28% 1/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Gastrointestinal disorders PNEUMOPERITONEUM	2.3% 8/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Gastrointestinal disorders SMALL INTESTINAL HAEMORRHAGE	0.28% 1/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Gastrointestinal disorders SMALL INTESTINAL OBSTRUCTION	0.56% 2/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Gastrointestinal disorders VOMITING	0.28% 1/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
General disorders ASTHENIA	0.28% 1/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
General disorders COMPLICATION OF DEVICE INSERTION	5.9% 21/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
General disorders DEATH	0.56% 2/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
General disorders DEVICE DISLOCATION	1.4% 5/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
General disorders DEVICE OCCLUSION	0.85% 3/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
General disorders IMPLANT SITE ULCER	0.28% 1/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
General disorders MEDICAL DEVICE COMPLICATION	0.28% 1/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
General disorders PAIN	0.28% 1/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
General disorders UNINTENTIONAL MEDICAL DEVICE REMOVAL BY PATIENT	0.56% 2/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Hepatobiliary disorders CHOLECYSTITIS	0.28% 1/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Hepatobiliary disorders HEPATIC FAILURE	0.28% 1/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Hepatobiliary disorders HEPATIC STEATOSIS	0.28% 1/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Infections and infestations ABDOMINAL INFECTION	0.28% 1/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Infections and infestations CLOSTRIDIUM DIFFICILE COLITIS	0.28% 1/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Infections and infestations GASTROENTERITIS	0.28% 1/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Infections and infestations GASTROENTERITIS VIRAL	0.28% 1/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Infections and infestations LUNG ABSCESS	0.28% 1/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Infections and infestations PERITONEAL ABSCESS	0.28% 1/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Infections and infestations PNEUMONIA	2.0% 7/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Infections and infestations POSTOPERATIVE WOUND INFECTION	0.85% 3/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Infections and infestations PYELONEPHRITIS	0.56% 2/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Infections and infestations PYELONEPHRITIS ACUTE	0.28% 1/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Infections and infestations SEPSIS	0.28% 1/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Infections and infestations SEPTIC SHOCK	0.28% 1/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Infections and infestations URINARY TRACT INFECTION	0.28% 1/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Infections and infestations UROSEPSIS	0.28% 1/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Infections and infestations VIRAL DIARRHOEA	0.28% 1/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Injury, poisoning and procedural complications BRAIN CONTUSION	0.28% 1/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Injury, poisoning and procedural complications CONTUSION	0.56% 2/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Injury, poisoning and procedural complications FALL	0.28% 1/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Injury, poisoning and procedural complications GASTROINTESTINAL STOMA COMPLICATION	0.28% 1/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Injury, poisoning and procedural complications HIP FRACTURE	1.7% 6/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Injury, poisoning and procedural complications LACERATION	0.28% 1/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Injury, poisoning and procedural complications POST PROCEDURAL COMPLICATION	0.56% 2/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Injury, poisoning and procedural complications POST PROCEDURAL HAEMORRHAGE	0.28% 1/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Injury, poisoning and procedural complications POSTOPERATIVE ILEUS	0.28% 1/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Injury, poisoning and procedural complications RADIUS FRACTURE	0.56% 2/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Injury, poisoning and procedural complications RIB FRACTURE	0.28% 1/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Injury, poisoning and procedural complications STERNAL FRACTURE	0.28% 1/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Injury, poisoning and procedural complications THORACIC VERTEBRAL FRACTURE	0.28% 1/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Injury, poisoning and procedural complications ULNA FRACTURE	0.28% 1/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Injury, poisoning and procedural complications UPPER LIMB FRACTURE	0.28% 1/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Investigations AMINO ACID LEVEL INCREASED	0.28% 1/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Investigations BLOOD LACTIC ACID INCREASED	0.28% 1/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Investigations WEIGHT DECREASED	1.1% 4/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Metabolism and nutrition disorders CACHEXIA	0.28% 1/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Metabolism and nutrition disorders DECREASED APPETITE	0.28% 1/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Metabolism and nutrition disorders FOLATE DEFICIENCY	0.28% 1/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Metabolism and nutrition disorders HYPERHOMOCYSTEINAEMIA	0.28% 1/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Metabolism and nutrition disorders HYPONATRAEMIA	0.28% 1/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Metabolism and nutrition disorders MALNUTRITION	0.56% 2/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Metabolism and nutrition disorders METABOLIC ACIDOSIS	0.28% 1/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Metabolism and nutrition disorders VITAMIN B12 DEFICIENCY	0.28% 1/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Metabolism and nutrition disorders VITAMIN B6 DEFICIENCY	0.28% 1/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Musculoskeletal and connective tissue disorders BACK PAIN	0.85% 3/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Musculoskeletal and connective tissue disorders BURSITIS	0.28% 1/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Musculoskeletal and connective tissue disorders RHABDOMYOLYSIS	0.28% 1/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BASAL CELL CARCINOMA	0.56% 2/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BENIGN SALIVARY GLAND NEOPLASM	0.28% 1/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) COLON ADENOMA	0.28% 1/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) PROSTATE CANCER	0.56% 2/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) RENAL CELL CARCINOMA	0.28% 1/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) SQUAMOUS CELL CARCINOMA	0.28% 1/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) SQUAMOUS CELL CARCINOMA OF SKIN	0.28% 1/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Nervous system disorders CEREBROVASCULAR ACCIDENT	0.28% 1/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Nervous system disorders DYSKINESIA	0.28% 1/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Nervous system disorders GUILLAIN-BARRE SYNDROME	0.56% 2/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Nervous system disorders HEADACHE	0.28% 1/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Nervous system disorders HEPATIC ENCEPHALOPATHY	0.28% 1/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Nervous system disorders HYPERKINESIA	0.28% 1/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Nervous system disorders MONOPLEGIA	0.28% 1/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Nervous system disorders MYELOPATHY	0.28% 1/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Nervous system disorders NEUROPATHY PERIPHERAL	0.28% 1/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Nervous system disorders ON AND OFF PHENOMENON	0.56% 2/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Nervous system disorders PARKINSON'S DISEASE	2.3% 8/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Nervous system disorders PARTIAL SEIZURES	0.28% 1/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Nervous system disorders PERIPHERAL SENSORIMOTOR NEUROPATHY	0.56% 2/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Nervous system disorders PERIPHERAL SENSORY NEUROPATHY	0.28% 1/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Nervous system disorders POLYNEUROPATHY	2.5% 9/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Nervous system disorders SYNCOPE	0.56% 2/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Psychiatric disorders ACUTE PSYCHOSIS	0.28% 1/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Psychiatric disorders AGITATION	0.28% 1/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Psychiatric disorders ANXIETY	0.28% 1/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Psychiatric disorders COMPLETED SUICIDE	0.56% 2/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Psychiatric disorders DELUSION	0.28% 1/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Psychiatric disorders DEPRESSION	1.1% 4/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Psychiatric disorders HALLUCINATION	0.56% 2/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Psychiatric disorders PSYCHOTIC DISORDER	0.56% 2/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Psychiatric disorders STEREOTYPY	0.28% 1/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Psychiatric disorders SUBSTANCE ABUSE	0.28% 1/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Psychiatric disorders SUICIDE ATTEMPT	0.56% 2/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Renal and urinary disorders CALCULUS URETERIC	0.56% 2/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Renal and urinary disorders NEPHROLITHIASIS	0.28% 1/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Renal and urinary disorders RENAL FAILURE ACUTE	0.28% 1/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Respiratory, thoracic and mediastinal disorders CHRONIC OBSTRUCTIVE PULMONARY DISEASE	0.28% 1/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Respiratory, thoracic and mediastinal disorders PLEURISY	0.28% 1/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Respiratory, thoracic and mediastinal disorders PNEUMONIA ASPIRATION	0.28% 1/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Respiratory, thoracic and mediastinal disorders PNEUMOTHORAX	0.56% 2/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Respiratory, thoracic and mediastinal disorders PULMONARY EMBOLISM	0.56% 2/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Respiratory, thoracic and mediastinal disorders RESPIRATORY FAILURE	0.28% 1/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Skin and subcutaneous tissue disorders EXCESSIVE GRANULATION TISSUE	0.28% 1/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Surgical and medical procedures KNEE ARTHROPLASTY	0.56% 2/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Vascular disorders DEEP VEIN THROMBOSIS	0.28% 1/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Vascular disorders HYPERTENSIVE CRISIS	0.28% 1/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Vascular disorders ORTHOSTATIC HYPOTENSION	0.28% 1/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.

Other adverse events

Measure	Levodopa-Carbidopa Intestinal Gel (LCIG) n=354 participants at risk All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment. The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances.
Gastrointestinal disorders ABDOMINAL PAIN	26.0% 92/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Gastrointestinal disorders CONSTIPATION	15.5% 55/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Gastrointestinal disorders DIARRHOEA	7.6% 27/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Gastrointestinal disorders DYSPEPSIA	6.8% 24/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Gastrointestinal disorders NAUSEA	16.9% 60/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Gastrointestinal disorders VOMITING	9.0% 32/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
General disorders COMPLICATION OF DEVICE INSERTION	28.8% 102/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Infections and infestations POSTOPERATIVE WOUND INFECTION	13.3% 47/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Infections and infestations URINARY TRACT INFECTION	10.5% 37/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Injury, poisoning and procedural complications FALL	14.1% 50/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Injury, poisoning and procedural complications INCISION SITE ERYTHEMA	12.1% 43/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Injury, poisoning and procedural complications INCISION SITE PAIN	5.9% 21/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Injury, poisoning and procedural complications POST PROCEDURAL DISCHARGE	7.3% 26/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Injury, poisoning and procedural complications PROCEDURAL PAIN	18.9% 67/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Injury, poisoning and procedural complications PROCEDURAL SITE REACTION	9.0% 32/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Investigations BLOOD HOMOCYSTEINE INCREASED	5.6% 20/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Investigations VITAMIN B6 DECREASED	5.6% 20/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Investigations WEIGHT DECREASED	9.0% 32/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Metabolism and nutrition disorders DECREASED APPETITE	5.1% 18/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Musculoskeletal and connective tissue disorders BACK PAIN	6.5% 23/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL PAIN	5.4% 19/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Musculoskeletal and connective tissue disorders PAIN IN EXTREMITY	5.4% 19/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Nervous system disorders DIZZINESS	5.1% 18/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Nervous system disorders DYSKINESIA	8.8% 31/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Nervous system disorders HEADACHE	8.5% 30/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Nervous system disorders PARKINSON'S DISEASE	7.1% 25/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Psychiatric disorders ANXIETY	11.3% 40/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Psychiatric disorders DEPRESSION	7.1% 25/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Psychiatric disorders INSOMNIA	18.9% 67/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Psychiatric disorders SLEEP ATTACKS	7.1% 25/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Respiratory, thoracic and mediastinal disorders OROPHARYNGEAL PAIN	7.1% 25/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Skin and subcutaneous tissue disorders EXCESSIVE GRANULATION TISSUE	14.4% 51/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.
Vascular disorders ORTHOSTATIC HYPOTENSION	7.9% 28/354 • From Screening to the end of study or early termination of treatment, including the removal of study device (up to 54 weeks), plus 30 days. Serious AEs and treatment-emergent AEs are presented. Treatment-emergent AEs were defined as AEs that began or worsened from date of the NJ device placement to the end of therapy (last dose of study drug or NJ/PEG-J removal, whichever is later) plus 30 days.

Additional Information

Global Medical Services

AbbVie (prior sponsor, Abbott)

Phone: 800-633-9110

Results disclosure agreements

• Principal investigator is a sponsor employee AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
• Publication restrictions are in place

Restriction type: OTHER