Trial Outcomes & Findings for Long-term Study of Duodopa (Levodopa/Carbidopa) in Advanced Parkinson's: Health Outcomes & Net Economic Impact (NCT NCT00141518)

Last Updated: 2016-07-18

Results Overview

The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. For Parts I-III and Total Score, each question is measured on a 5-point scale of 0 (normal or no disease effect) to 4 (maximum negative effect); for Part IV, questions are measured on a 5- or 2-point scale (0 or 1). Part I score is the sum of answers to 'Mentation, Behavior and Mood' questions, with a score range from 0-16. Part II score is the sum of answers to 'Activities of Daily Living' questions, with a score range from 0-52. Part III score is the sum of answers to 'Motor Examination' questions, with a score range from 0-108. Part IV score is the sum of answers to 'Complications of Therapy' questions, with a score range from 0-23. Total Score is the sum of the responses to the 31 questions (44 answers) that comprise Parts I-III of the scale, with a score range from 0-176. Higher scores are associated with more disability.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

77 participants

Primary outcome timeframe

Baseline (Month -3), Month 12

Results posted on

2016-07-18

Participant Flow

Participant milestones

Participant milestones
Measure	Duodopa Naïve Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Duodopa Non-naïve < 2 Years Duodopa non-naïve participants treated with Duodopa for \< 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Duodopa Non-naïve ≥ 2 Years Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.
Overall Study STARTED	37	22	18
Overall Study Safety Sample	36	22	18
Overall Study Full Analysis Sample	27	22	18
Overall Study COMPLETED	21	16	12
Overall Study NOT COMPLETED	16	6	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Duodopa Naïve Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Duodopa Non-naïve < 2 Years Duodopa non-naïve participants treated with Duodopa for \< 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Duodopa Non-naïve ≥ 2 Years Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.
Overall Study Withdrew Consent Prior to Treatment	1	0	0
Overall Study Adverse Event	7	5	2
Overall Study Withdrawal by Subject	2	0	2
Overall Study Protocol Violation	1	1	2
Overall Study Lack of Efficacy	5	0	0

Baseline Characteristics

Long-term Study of Duodopa (Levodopa/Carbidopa) in Advanced Parkinson's: Health Outcomes & Net Economic Impact

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Duodopa Naïve n=27 Participants Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Duodopa Non-naïve < 2 Years n=22 Participants Duodopa non-naïve participants treated with Duodopa for \< 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Duodopa Non-naïve ≥ 2 Years n=18 Participants Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Total n=67 Participants Total of all reporting groups
Age, Continuous	64.6 years STANDARD_DEVIATION 6.4 • n=5 Participants	65.4 years STANDARD_DEVIATION 5.2 • n=7 Participants	66.6 years STANDARD_DEVIATION 8.7 • n=5 Participants	65.4 years STANDARD_DEVIATION 6.8 • n=4 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	7 Participants n=7 Participants	6 Participants n=5 Participants	24 Participants n=4 Participants
Sex: Female, Male Male	16 Participants n=5 Participants	15 Participants n=7 Participants	12 Participants n=5 Participants	43 Participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline (Month -3), Month 12

Population: Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.

Outcome measures

Outcome measures
Measure	Duodopa Non-naïve ≥ 2 Years n=18 Participants Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Duodopa Naïve n=27 Participants Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Duodopa Non-naïve < 2 Years n=22 Participants Duodopa non-naïve participants treated with Duodopa for \< 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Total All participants
Unified Parkinson's Disease Rating Scale (UPDRS) Total Score, and UPDRS Subscores I, II, III, and IV at Baseline and Month 12 Part I, Baseline (Month -3); n=27, 0, 0	NA units on a scale Standard Deviation NA Baseline for Duodopa non-naive participants was not done.	2.9 units on a scale Standard Deviation 1.9	NA units on a scale Standard Deviation NA Baseline for Duodopa non-naive participants was not done.	—
Unified Parkinson's Disease Rating Scale (UPDRS) Total Score, and UPDRS Subscores I, II, III, and IV at Baseline and Month 12 Total Score, Baseline (Month -3); n=27, 0, 0	NA units on a scale Standard Deviation NA Baseline for Duodopa non-naive participants was not done.	52.1 units on a scale Standard Deviation 16.1	NA units on a scale Standard Deviation NA Baseline for Duodopa non-naive participants was not done.	—
Unified Parkinson's Disease Rating Scale (UPDRS) Total Score, and UPDRS Subscores I, II, III, and IV at Baseline and Month 12 Total Score, Month 12; n=25, 20, 17	48.2 units on a scale Standard Deviation 18.4	42.5 units on a scale Standard Deviation 22.6	44.0 units on a scale Standard Deviation 13.9	—
Unified Parkinson's Disease Rating Scale (UPDRS) Total Score, and UPDRS Subscores I, II, III, and IV at Baseline and Month 12 Part I, Month 12; n=25, 20, 17	3.2 units on a scale Standard Deviation 2.2	3.1 units on a scale Standard Deviation 2.2	2.6 units on a scale Standard Deviation 2.0	—
Unified Parkinson's Disease Rating Scale (UPDRS) Total Score, and UPDRS Subscores I, II, III, and IV at Baseline and Month 12 Part II, Baseline (Month -3); n=27, 0, 0	NA units on a scale Standard Deviation NA Baseline for Duodopa non-naive participants was not done.	15.4 units on a scale Standard Deviation 5.7	NA units on a scale Standard Deviation NA Baseline for Duodopa non-naive participants was not done.	—
Unified Parkinson's Disease Rating Scale (UPDRS) Total Score, and UPDRS Subscores I, II, III, and IV at Baseline and Month 12 Part II, Month 12; n=25, 20, 17	14.3 units on a scale Standard Deviation 6.0	12.2 units on a scale Standard Deviation 6.8	13.4 units on a scale Standard Deviation 5.7	—
Unified Parkinson's Disease Rating Scale (UPDRS) Total Score, and UPDRS Subscores I, II, III, and IV at Baseline and Month 12 Part III, Baseline (Month -3); n=27, 0, 0	NA units on a scale Standard Deviation NA Baseline for Duodopa non-naive participants was not done.	24.4 units on a scale Standard Deviation 11.0	NA units on a scale Standard Deviation NA Baseline for Duodopa non-naive participants was not done.	—
Unified Parkinson's Disease Rating Scale (UPDRS) Total Score, and UPDRS Subscores I, II, III, and IV at Baseline and Month 12 Part III, Month 12; n=25, 20, 17	23.5 units on a scale Standard Deviation 11.5	21.5 units on a scale Standard Deviation 13.2	21.2 units on a scale Standard Deviation 10.0	—
Unified Parkinson's Disease Rating Scale (UPDRS) Total Score, and UPDRS Subscores I, II, III, and IV at Baseline and Month 12 Part IV, Baseline (Month -3); n=27, 0, 0	NA units on a scale Standard Deviation NA Baseline for Duodopa non-naive participants was not done.	9.4 units on a scale Standard Deviation 2.6	NA units on a scale Standard Deviation NA Baseline for Duodopa non-naive participants was not done.	—
Unified Parkinson's Disease Rating Scale (UPDRS) Total Score, and UPDRS Subscores I, II, III, and IV at Baseline and Month 12 Part IV, Month 12; n=25, 20, 17	7.2 units on a scale Standard Deviation 3.5	5.7 units on a scale Standard Deviation 3.4	7.0 units on a scale Standard Deviation 2.5	—

PRIMARY outcome

Timeframe: Baseline (Month -3), Month 12

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 (worst health state) to 1.00 (perfect health state).

Outcome measures

Outcome measures
Measure	Duodopa Non-naïve ≥ 2 Years n=18 Participants Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Duodopa Naïve n=27 Participants Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Duodopa Non-naïve < 2 Years n=22 Participants Duodopa non-naïve participants treated with Duodopa for \< 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Total All participants
Euro QoL 5 Dimensions Quality of Life Instrument (EQ-5D) Descriptive Systems Summary Index Score at Baseline and Month 12 Baseline (Month -3); n=27, 0, 0	NA units on a scale Standard Deviation NA Baseline for Duodopa non-naive participants was not done.	0.57 units on a scale Standard Deviation 0.26	NA units on a scale Standard Deviation NA Baseline for Duodopa non-naive participants was not done.	—
Euro QoL 5 Dimensions Quality of Life Instrument (EQ-5D) Descriptive Systems Summary Index Score at Baseline and Month 12 Month 12; n=25, 20, 17	0.51 units on a scale Standard Deviation 0.37	0.59 units on a scale Standard Deviation 0.33	0.66 units on a scale Standard Deviation 0.36	—

PRIMARY outcome

Timeframe: Baseline (Month -3), Month 12

Population: Full Analysis Set: Participants who had ≥ 1 dose of study medication and (for Duodopa naives) had data for baseline and ≥ 1 post-baseline assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥ 1 more assessment of the primary efficacy measurements UPDRS and EQ-5D.

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.' The scale was normalized to a scale of 0 to 1, with higher values indicating a better health state.

Outcome measures

Outcome measures
Measure	Duodopa Non-naïve ≥ 2 Years n=18 Participants Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Duodopa Naïve n=27 Participants Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Duodopa Non-naïve < 2 Years n=22 Participants Duodopa non-naïve participants treated with Duodopa for \< 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Total All participants
EQ-5D Visual Analog Scale (VAS) Score at Baseline and Month 12 Baseline (Month -3); n=27, 0, 0	NA units on a scale Standard Deviation NA Baseline for Duodopa non-naive participants was not done.	0.44 units on a scale Standard Deviation 0.20	NA units on a scale Standard Deviation NA Baseline for Duodopa non-naive participants was not done.	—
EQ-5D Visual Analog Scale (VAS) Score at Baseline and Month 12 Month 12; n=25, 19, 17	0.64 units on a scale Standard Deviation 0.22	0.63 units on a scale Standard Deviation 0.18	0.64 units on a scale Standard Deviation 0.19	—

PRIMARY outcome

Timeframe: Baseline (month -3) for Duodopa-naïve participants, then at Month 0, and monthly thereafter until study completion (up to 48 months) for all participants

Total monthly costs include * Direct medical costs (inpatient care, outpatient care, and drug costs \[including Duodopa cost and cost of concomitant anti-PD medication\]). * Direct non-medical costs (nursing home, home help, personal assistance, informal care \[from family member or friend\] and transportation to inpatient, outpatient visits and nursing home). * Indirect costs (sick-leave and early retirement due to PD \[applied to individuals only up to the age of 65 since the main indirect cost item, early retirement due to disability, is only available for individuals 30-64 years old. Sixty-five is also a common retirement age in Sweden\]). The average rate for US Dollar (USD) to SEK on 31 December 2010 was 1 USD = 6.734 SEK.

Outcome measures

Outcome measures
Measure	Duodopa Non-naïve ≥ 2 Years n=574 Patient-months per Study Arm Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Duodopa Naïve n=920 Patient-months per Study Arm Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Duodopa Non-naïve < 2 Years n=710 Patient-months per Study Arm Duodopa non-naïve participants treated with Duodopa for \< 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Total n=2204 Patient-months per Study Arm All participants
Total Monthly Cost Per Participant, in Swedish Crowns (SEK) 2010	82177 SEK 2010 Standard Deviation 53728	78418 SEK 2010 Standard Deviation 42028	75521 SEK 2010 Standard Deviation 73296	78464 SEK 2010 Standard Deviation 56772

PRIMARY outcome

Timeframe: Baseline (month -3) for Duodopa-naïve participants, then at Month 0, and monthly thereafter until study completion (up to 48 months) for all participants

Drug costs include Duodopa cost and cost of concomitant anti-PD medication. Drug costs are a direct medical cost. The average rate for US Dollar (USD) to SEK on 31 December 2010 was 1 USD = 6.734 SEK.

Outcome measures

Outcome measures
Measure	Duodopa Non-naïve ≥ 2 Years n=574 Patient-months per Study Arm Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Duodopa Naïve n=920 Patient-months per Study Arm Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Duodopa Non-naïve < 2 Years n=710 Patient-months per Study Arm Duodopa non-naïve participants treated with Duodopa for \< 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Total n=2204 Patient-months per Study Arm All participants
Monthly Drug Costs Per Participant, SEK 2010	37679 SEK 2010 Standard Deviation 15196	39382 SEK 2010 Standard Deviation 16733	34417 SEK 2010 Standard Deviation 10494	37339 SEK 2010 Standard Deviation 14725

PRIMARY outcome

Timeframe: Baseline (month -3) for Duodopa-naïve participants, then at Month 0, and monthly thereafter until study completion (up to 48 months) for all participants

Direct medical costs consist of inpatient care, outpatient care (visits to physician, nurse, physiotherapist, occupational therapist, dietitian, speech therapist, counselor, and phone consultations). The average rate for US Dollar (USD) to SEK on 31 December 2010 was 1 USD = 6.734 SEK.

Outcome measures

Outcome measures
Measure	Duodopa Non-naïve ≥ 2 Years n=574 Patient-months per Study Arm Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Duodopa Naïve n=920 Patient-months per Study Arm Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Duodopa Non-naïve < 2 Years n=710 Patient-months per Study Arm Duodopa non-naïve participants treated with Duodopa for \< 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Total n=2204 Patient-months per Study Arm All participants
Monthly Direct Medical Cost (Excluding Drug Costs) Per Participant, SEK 2010	3607 SEK 2010 Standard Deviation 8648	3825 SEK 2010 Standard Deviation 9394	4552 SEK 2010 Standard Deviation 11819	4002 SEK 2010 Standard Deviation 10069

PRIMARY outcome

Timeframe: Baseline (month -3) for Duodopa-naïve participants, then at Month 0, and monthly thereafter until study completion (up to 48 months) for all participants

Direct non-medical costs include nursing home, home help, personal assistance, informal care (from family member or friend) and transportation to inpatient, outpatient visits and nursing home. The average rate for US Dollar (USD) to SEK on 31 December 2010 was 1 USD = 6.734 SEK.

Outcome measures

Outcome measures
Measure	Duodopa Non-naïve ≥ 2 Years n=574 Patient-months per Study Arm Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Duodopa Naïve n=920 Patient-months per Study Arm Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Duodopa Non-naïve < 2 Years n=710 Patient-months per Study Arm Duodopa non-naïve participants treated with Duodopa for \< 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Total n=2204 Patient-months per Study Arm All participants
Direct Monthly Non-medical Costs Per Participant, SEK 2010	25008 SEK 2010 Standard Deviation 42455	19274 SEK 2010 Standard Deviation 26485	27439 SEK 2010 Standard Deviation 61656	23398 SEK 2010 Standard Deviation 44698

PRIMARY outcome

Timeframe: Baseline (month -3) for Duodopa-naïve participants, then at Month 0, and monthly thereafter until Month 36

Population: All participants; n=fraction of number of participants younger than 65 years with indirect costs / number of participants assessed at given time point.

Indirect costs consist of sick-leave and early retirement due to PD, are applied to individuals only up to the age of 65 since the main indirect cost item - early retirement due to disability - is only available for individuals 30-64 years old. Sixty-five is also a common retirement age in Sweden. The average rate for US Dollar (USD) to SEK on 31 December 2010 was 1 USD = 6.734 SEK.

Outcome measures

Outcome measures
Measure	Duodopa Non-naïve ≥ 2 Years Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Duodopa Naïve n=77 Participants Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Duodopa Non-naïve < 2 Years Duodopa non-naïve participants treated with Duodopa for \< 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Total All participants
Indirect Monthly Costs Per Participant (Only Applied to Participants Younger Than 65) by Study Month, SEK 2010 Month 6; n=21/65	—	13250 SEK 2010 Standard Deviation 19498	—	—
Indirect Monthly Costs Per Participant (Only Applied to Participants Younger Than 65) by Study Month, SEK 2010 Month 7; n=24/65	—	15512 SEK 2010 Standard Deviation 20433	—	—
Indirect Monthly Costs Per Participant (Only Applied to Participants Younger Than 65) by Study Month, SEK 2010 Month 8; n=24/63	—	16005 SEK 2010 Standard Deviation 20566	—	—
Indirect Monthly Costs Per Participant (Only Applied to Participants Younger Than 65) by Study Month, SEK 2010 Month 9; n=22/62	—	14569 SEK 2010 Standard Deviation 19978	—	—
Indirect Monthly Costs Per Participant (Only Applied to Participants Younger Than 65) by Study Month, SEK 2010 Month -3; n=15/37	—	17032 SEK 2010 Standard Deviation 20911	—	—
Indirect Monthly Costs Per Participant (Only Applied to Participants Younger Than 65) by Study Month, SEK 2010 Month 0; n=23/67	—	14109 SEK 2010 Standard Deviation 19823	—	—
Indirect Monthly Costs Per Participant (Only Applied to Participants Younger Than 65) by Study Month, SEK 2010 Month 1; n=23/67	—	14109 SEK 2010 Standard Deviation 19823	—	—
Indirect Monthly Costs Per Participant (Only Applied to Participants Younger Than 65) by Study Month, SEK 2010 Month 2; n=22/65	—	13896 SEK 2010 Standard Deviation 19746	—	—
Indirect Monthly Costs Per Participant (Only Applied to Participants Younger Than 65) by Study Month, SEK 2010 Month 3; n=23/65	—	14543 SEK 2010 Standard Deviation 19971	—	—
Indirect Monthly Costs Per Participant (Only Applied to Participants Younger Than 65) by Study Month, SEK 2010 Month 4; n=23/65	—	14543 SEK 2010 Standard Deviation 19971	—	—
Indirect Monthly Costs Per Participant (Only Applied to Participants Younger Than 65) by Study Month, SEK 2010 Month 22; n=18/57	—	12530 SEK 2010 Standard Deviation 18980	—	—
Indirect Monthly Costs Per Participant (Only Applied to Participants Younger Than 65) by Study Month, SEK 2010 Month 23; n=18/57	—	12530 SEK 2010 Standard Deviation 18980	—	—
Indirect Monthly Costs Per Participant (Only Applied to Participants Younger Than 65) by Study Month, SEK 2010 Month 24; n=17/56	—	12003 SEK 2010 Standard Deviation 18727	—	—
Indirect Monthly Costs Per Participant (Only Applied to Participants Younger Than 65) by Study Month, SEK 2010 Month 25; n=16/54	—	12059 SEK 2010 Standard Deviation 18966	—	—
Indirect Monthly Costs Per Participant (Only Applied to Participants Younger Than 65) by Study Month, SEK 2010 Month 27; n=16/53	—	12683 SEK 2010 Standard Deviation 19471	—	—
Indirect Monthly Costs Per Participant (Only Applied to Participants Younger Than 65) by Study Month, SEK 2010 Month 32; n=14/50	—	11763 SEK 2010 Standard Deviation 19055	—	—
Indirect Monthly Costs Per Participant (Only Applied to Participants Younger Than 65) by Study Month, SEK 2010 Month 26; n=18/54	—	13615 SEK 2010 Standard Deviation 19637	—	—
Indirect Monthly Costs Per Participant (Only Applied to Participants Younger Than 65) by Study Month, SEK 2010 Month 28; n=15/53	—	11890 SEK 2010 Standard Deviation 19106	—	—
Indirect Monthly Costs Per Participant (Only Applied to Participants Younger Than 65) by Study Month, SEK 2010 Month 29; n=16/53	—	12683 SEK 2010 Standard Deviation 19471	—	—
Indirect Monthly Costs Per Participant (Only Applied to Participants Younger Than 65) by Study Month, SEK 2010 Month 30; n=16/53	—	12683 SEK 2010 Standard Deviation 19471	—	—
Indirect Monthly Costs Per Participant (Only Applied to Participants Younger Than 65) by Study Month, SEK 2010 Month 31; n=15/50	—	12604 SEK 2010 Standard Deviation 19448	—	—
Indirect Monthly Costs Per Participant (Only Applied to Participants Younger Than 65) by Study Month, SEK 2010 Month 33; n=14/50	—	11763 SEK 2010 Standard Deviation 19055	—	—
Indirect Monthly Costs Per Participant (Only Applied to Participants Younger Than 65) by Study Month, SEK 2010 Month 34; n=14/49	—	12003 SEK 2010 Standard Deviation 19176	—	—
Indirect Monthly Costs Per Participant (Only Applied to Participants Younger Than 65) by Study Month, SEK 2010 Month 35; n=14/49	—	12003 SEK 2010 Standard Deviation 19176	—	—
Indirect Monthly Costs Per Participant (Only Applied to Participants Younger Than 65) by Study Month, SEK 2010 Month 36; n=15/49	—	12432 SEK 2010 Standard Deviation 19137	—	—
Indirect Monthly Costs Per Participant (Only Applied to Participants Younger Than 65) by Study Month, SEK 2010 Month 5; n=22/65	—	13896 SEK 2010 Standard Deviation 19746	—	—
Indirect Monthly Costs Per Participant (Only Applied to Participants Younger Than 65) by Study Month, SEK 2010 Month 10; n=22/62	—	14569 SEK 2010 Standard Deviation 19978	—	—
Indirect Monthly Costs Per Participant (Only Applied to Participants Younger Than 65) by Study Month, SEK 2010 Month 11; n=22/62	—	14399 SEK 2010 Standard Deviation 19785	—	—
Indirect Monthly Costs Per Participant (Only Applied to Participants Younger Than 65) by Study Month, SEK 2010 Month 12; n=22/62	—	14399 SEK 2010 Standard Deviation 19785	—	—
Indirect Monthly Costs Per Participant (Only Applied to Participants Younger Than 65) by Study Month, SEK 2010 Month 13; n=22/62	—	14230 SEK 2010 Standard Deviation 19681	—	—
Indirect Monthly Costs Per Participant (Only Applied to Participants Younger Than 65) by Study Month, SEK 2010 Month 14; n=22/62	—	14569 SEK 2010 Standard Deviation 19978	—	—
Indirect Monthly Costs Per Participant (Only Applied to Participants Younger Than 65) by Study Month, SEK 2010 Month 15; n=22/61	—	14808 SEK 2010 Standard Deviation 20055	—	—
Indirect Monthly Costs Per Participant (Only Applied to Participants Younger Than 65) by Study Month, SEK 2010 Month 16; n=22/61	—	14808 SEK 2010 Standard Deviation 20055	—	—
Indirect Monthly Costs Per Participant (Only Applied to Participants Younger Than 65) by Study Month, SEK 2010 Month 17; n=22/61	—	14463 SEK 2010 Standard Deviation 19758	—	—
Indirect Monthly Costs Per Participant (Only Applied to Participants Younger Than 65) by Study Month, SEK 2010 Month 18; n=22/61	—	14463 SEK 2010 Standard Deviation 19758	—	—
Indirect Monthly Costs Per Participant (Only Applied to Participants Younger Than 65) by Study Month, SEK 2010 Month 19; n=22/60	—	14704 SEK 2010 Standard Deviation 19834	—	—
Indirect Monthly Costs Per Participant (Only Applied to Participants Younger Than 65) by Study Month, SEK 2010 Month 20; n=20/59	—	13529 SEK 2010 Standard Deviation 19411	—	—
Indirect Monthly Costs Per Participant (Only Applied to Participants Younger Than 65) by Study Month, SEK 2010 Month 21; n=20/58	—	13763 SEK 2010 Standard Deviation 19497	—	—

SECONDARY outcome

Timeframe: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)

The current stage of PD was characterized according to Modified Hoehn and Yahr criteria, measured on the following 8-point scale for staging: 0=no signs of disease; 1=unilateral disease; 1.5=unilateral plus axial involvement; 2=bilateral disease; 2.5=mild bilateral disease; 3=mild to moderate bilateral disease; 4=severe disability; and 5=wheelchair bound or bedridden unless aided.

Outcome measures

Outcome measures
Measure	Duodopa Non-naïve ≥ 2 Years n=18 Participants Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Duodopa Naïve n=27 Participants Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Duodopa Non-naïve < 2 Years n=22 Participants Duodopa non-naïve participants treated with Duodopa for \< 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Total All participants
Modified Hoehn and Yahr Staging: Current Stage From Baseline to Month 36 Baseline (Month -3); n=27, 0, 0	NA units on a scale Standard Deviation NA Baseline for Duodopa non-naive participants was not done.	2.7 units on a scale Standard Deviation 0.7	NA units on a scale Standard Deviation NA Baseline for Duodopa non-naive participants was not done.	—
Modified Hoehn and Yahr Staging: Current Stage From Baseline to Month 36 Month 0; n=27, 22, 18	3.2 units on a scale Standard Deviation 0.8	2.5 units on a scale Standard Deviation 0.7	2.7 units on a scale Standard Deviation 0.8	—
Modified Hoehn and Yahr Staging: Current Stage From Baseline to Month 36 Month 12; n=25, 20, 17	3.3 units on a scale Standard Deviation 0.8	2.4 units on a scale Standard Deviation 0.8	2.8 units on a scale Standard Deviation 0.7	—
Modified Hoehn and Yahr Staging: Current Stage From Baseline to Month 36 Month 36; n=21, 16, 12	3.3 units on a scale Standard Deviation 0.9	2.7 units on a scale Standard Deviation 1.2	2.9 units on a scale Standard Deviation 0.6	—
Modified Hoehn and Yahr Staging: Current Stage From Baseline to Month 36 Month 3; n=24, 22, 18	3.0 units on a scale Standard Deviation 0.8	2.3 units on a scale Standard Deviation 0.8	2.7 units on a scale Standard Deviation 0.8	—
Modified Hoehn and Yahr Staging: Current Stage From Baseline to Month 36 Month 6; n=25, 22, 18	3.1 units on a scale Standard Deviation 0.8	2.4 units on a scale Standard Deviation 0.8	2.6 units on a scale Standard Deviation 0.9	—
Modified Hoehn and Yahr Staging: Current Stage From Baseline to Month 36 Month 9; n=25, 20, 17	3.1 units on a scale Standard Deviation 0.7	2.4 units on a scale Standard Deviation 1.0	2.7 units on a scale Standard Deviation 0.7	—
Modified Hoehn and Yahr Staging: Current Stage From Baseline to Month 36 Month 18; n=24, 20, 17	3.4 units on a scale Standard Deviation 1.0	2.4 units on a scale Standard Deviation 0.9	2.7 units on a scale Standard Deviation 0.7	—
Modified Hoehn and Yahr Staging: Current Stage From Baseline to Month 36 Month 24; 23, 18, 15	3.2 units on a scale Standard Deviation 0.8	2.5 units on a scale Standard Deviation 0.9	3.0 units on a scale Standard Deviation 0.9	—
Modified Hoehn and Yahr Staging: Current Stage From Baseline to Month 36 Month 30; n=23, 17, 13	3.1 units on a scale Standard Deviation 0.9	2.7 units on a scale Standard Deviation 1.1	2.9 units on a scale Standard Deviation 0.8	—
Modified Hoehn and Yahr Staging: Current Stage From Baseline to Month 36 Endpoint; n=27, 22, 18	3.4 units on a scale Standard Deviation 0.8	2.7 units on a scale Standard Deviation 1.1	3.1 units on a scale Standard Deviation 0.8	—

SECONDARY outcome

Timeframe: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)

The best PD stage that the participant experienced during the last month was characterized according to Modified Hoehn and Yahr criteria, measured on the following 8-point scale for staging: 0=no signs of disease; 1=unilateral disease; 1.5=unilateral plus axial involvement; 2=bilateral disease; 2.5=mild bilateral disease; 3=mild to moderate bilateral disease; 4=severe disability; and 5=wheelchair bound or bedridden unless aided.

Outcome measures

Outcome measures
Measure	Duodopa Non-naïve ≥ 2 Years n=18 Participants Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Duodopa Naïve n=27 Participants Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Duodopa Non-naïve < 2 Years n=22 Participants Duodopa non-naïve participants treated with Duodopa for \< 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Total All participants
Modified Hoehn and Yahr Staging: Best Stage From Baseline to Month 36 Baseline (Month -3); n=27, 0, 0	NA units on a scale Standard Deviation NA Baseline for Duodopa non-naive participants was not done.	2.2 units on a scale Standard Deviation 1.2	NA units on a scale Standard Deviation NA Baseline for Duodopa non-naive participants was not done.	—
Modified Hoehn and Yahr Staging: Best Stage From Baseline to Month 36 Month 6; n=25, 22, 18	2.6 units on a scale Standard Deviation 0.9	2.0 units on a scale Standard Deviation 0.8	2.5 units on a scale Standard Deviation 0.7	—
Modified Hoehn and Yahr Staging: Best Stage From Baseline to Month 36 Month 12; n=25, 20, 17	2.9 units on a scale Standard Deviation 0.8	2.2 units on a scale Standard Deviation 0.8	2.6 units on a scale Standard Deviation 0.9	—
Modified Hoehn and Yahr Staging: Best Stage From Baseline to Month 36 Month 24; n=23, 18, 15	2.9 units on a scale Standard Deviation 0.8	2.3 units on a scale Standard Deviation 1.1	2.6 units on a scale Standard Deviation 1.0	—
Modified Hoehn and Yahr Staging: Best Stage From Baseline to Month 36 Month 36; n=21, 16, 12	3.0 units on a scale Standard Deviation 0.7	2.5 units on a scale Standard Deviation 1.3	2.6 units on a scale Standard Deviation 0.6	—
Modified Hoehn and Yahr Staging: Best Stage From Baseline to Month 36 Endpoint; n=27, 22, 18	3.1 units on a scale Standard Deviation 0.8	2.6 units on a scale Standard Deviation 1.2	2.7 units on a scale Standard Deviation 0.7	—
Modified Hoehn and Yahr Staging: Best Stage From Baseline to Month 36 Month 0; n=27, 22, 18	2.5 units on a scale Standard Deviation 0.7	2.0 units on a scale Standard Deviation 0.9	2.5 units on a scale Standard Deviation 0.7	—
Modified Hoehn and Yahr Staging: Best Stage From Baseline to Month 36 Month 3; n=24, 22, 18	2.6 units on a scale Standard Deviation 0.8	2.0 units on a scale Standard Deviation 0.9	2.5 units on a scale Standard Deviation 0.6	—
Modified Hoehn and Yahr Staging: Best Stage From Baseline to Month 36 Month 9; 25, 20, 17	2.7 units on a scale Standard Deviation 0.7	2.2 units on a scale Standard Deviation 1.1	2.5 units on a scale Standard Deviation 0.7	—
Modified Hoehn and Yahr Staging: Best Stage From Baseline to Month 36 Month 18; n=24, 20, 17	2.9 units on a scale Standard Deviation 0.9	2.2 units on a scale Standard Deviation 0.9	2.5 units on a scale Standard Deviation 0.9	—
Modified Hoehn and Yahr Staging: Best Stage From Baseline to Month 36 Month 30; n=23, 17, 13	3.0 units on a scale Standard Deviation 0.9	2.5 units on a scale Standard Deviation 1.2	2.6 units on a scale Standard Deviation 1.0	—

SECONDARY outcome

Timeframe: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)

The worst PD stage that the participant experienced during the last month was characterized according to Modified Hoehn and Yahr criteria, measured on the following 8-point scale for staging: 0=no signs of disease; 1=unilateral disease; 1.5=unilateral plus axial involvement; 2=bilateral disease; 2.5=mild bilateral disease; 3=mild to moderate bilateral disease; 4=severe disability; and 5=wheelchair bound or bedridden unless aided.

Outcome measures

Outcome measures
Measure	Duodopa Non-naïve ≥ 2 Years n=18 Participants Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Duodopa Naïve n=27 Participants Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Duodopa Non-naïve < 2 Years n=22 Participants Duodopa non-naïve participants treated with Duodopa for \< 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Total All participants
Modified Hoehn and Yahr Staging: Worst Stage From Baseline to Month 36 Baseline (Month -3); n=27, 0, 0	NA units on a scale Standard Deviation NA Baseline for Duodopa non-naive participants was not done.	3.8 units on a scale Standard Deviation 1.0	NA units on a scale Standard Deviation NA Baseline for Duodopa non-naive participants was not done.	—
Modified Hoehn and Yahr Staging: Worst Stage From Baseline to Month 36 Month 0; n=27, 22, 18	4.0 units on a scale Standard Deviation 0.6	3.6 units on a scale Standard Deviation 1.1	3.7 units on a scale Standard Deviation 0.9	—
Modified Hoehn and Yahr Staging: Worst Stage From Baseline to Month 36 Month 18; n=24, 20, 17	4.3 units on a scale Standard Deviation 0.6	3.8 units on a scale Standard Deviation 1.3	3.9 units on a scale Standard Deviation 0.8	—
Modified Hoehn and Yahr Staging: Worst Stage From Baseline to Month 36 Month 24; n=23, 18, 15	4.4 units on a scale Standard Deviation 0.5	3.9 units on a scale Standard Deviation 1.3	3.8 units on a scale Standard Deviation 0.8	—
Modified Hoehn and Yahr Staging: Worst Stage From Baseline to Month 36 Month 30; n=23, 17, 13	4.5 units on a scale Standard Deviation 0.7	4.0 units on a scale Standard Deviation 1.1	4.0 units on a scale Standard Deviation 0.8	—
Modified Hoehn and Yahr Staging: Worst Stage From Baseline to Month 36 Month 36; n=21, 16, 12	4.6 units on a scale Standard Deviation 0.5	3.9 units on a scale Standard Deviation 1.2	4.0 units on a scale Standard Deviation 0.6	—
Modified Hoehn and Yahr Staging: Worst Stage From Baseline to Month 36 Month 3; n=24, 22, 18	4.1 units on a scale Standard Deviation 0.7	3.8 units on a scale Standard Deviation 1.2	3.7 units on a scale Standard Deviation 0.9	—
Modified Hoehn and Yahr Staging: Worst Stage From Baseline to Month 36 Month 6; n=25, 22, 18	4.0 units on a scale Standard Deviation 0.7	3.7 units on a scale Standard Deviation 1.3	3.7 units on a scale Standard Deviation 1.1	—
Modified Hoehn and Yahr Staging: Worst Stage From Baseline to Month 36 Month 9; n=25, 20, 17	4.0 units on a scale Standard Deviation 0.5	3.7 units on a scale Standard Deviation 1.2	3.8 units on a scale Standard Deviation 0.7	—
Modified Hoehn and Yahr Staging: Worst Stage From Baseline to Month 36 Month 12; n=25, 20, 17	4.2 units on a scale Standard Deviation 0.5	3.6 units on a scale Standard Deviation 1.3	3.8 units on a scale Standard Deviation 0.8	—
Modified Hoehn and Yahr Staging: Worst Stage From Baseline to Month 36 Endpoint; n=27, 22, 18	4.5 units on a scale Standard Deviation 0.5	3.9 units on a scale Standard Deviation 1.1	4.0 units on a scale Standard Deviation 0.7	—

SECONDARY outcome

Timeframe: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)

The Schwab and England scale was used to rate the subject's best "on" period during the past week by recording the percentage score, ranging between being completely independent (100%) and totally dependent (10%). "On" time is when PD symptoms are well controlled by the drug.

Outcome measures

Outcome measures
Measure	Duodopa Non-naïve ≥ 2 Years n=18 Participants Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Duodopa Naïve n=27 Participants Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Duodopa Non-naïve < 2 Years n=22 Participants Duodopa non-naïve participants treated with Duodopa for \< 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Total All participants
Schwab and England Scale: Best "On" Period Stage From Baseline to Month 36 Month 9; n=25, 20, 17	70.6 percentage score on a scale Standard Deviation 13.0	79.2 percentage score on a scale Standard Deviation 13.5	76.5 percentage score on a scale Standard Deviation 13.1	—
Schwab and England Scale: Best "On" Period Stage From Baseline to Month 36 Month 12; n=25, 20, 17	71.8 percentage score on a scale Standard Deviation 12.4	77.2 percentage score on a scale Standard Deviation 13.4	72.5 percentage score on a scale Standard Deviation 15.9	—
Schwab and England Scale: Best "On" Period Stage From Baseline to Month 36 Baseline (Month -3); n=27, 0, 0	NA percentage score on a scale Standard Deviation NA Baseline for Duodopa non-naive participants was not done.	74.4 percentage score on a scale Standard Deviation 15.8	NA percentage score on a scale Standard Deviation NA Baseline for Duodopa non-naive participants was not done.	—
Schwab and England Scale: Best "On" Period Stage From Baseline to Month 36 Month 0; n=27, 22, 18	74.4 percentage score on a scale Standard Deviation 11.5	80.4 percentage score on a scale Standard Deviation 13.2	75.5 percentage score on a scale Standard Deviation 14.4	—
Schwab and England Scale: Best "On" Period Stage From Baseline to Month 36 Month 3; n=24, 22, 18	72.2 percentage score on a scale Standard Deviation 15.2	77.9 percentage score on a scale Standard Deviation 14.4	75.9 percentage score on a scale Standard Deviation 14.4	—
Schwab and England Scale: Best "On" Period Stage From Baseline to Month 36 Month 6; n=25, 22, 18	72.2 percentage score on a scale Standard Deviation 12.6	75.2 percentage score on a scale Standard Deviation 15.3	77.3 percentage score on a scale Standard Deviation 11.6	—
Schwab and England Scale: Best "On" Period Stage From Baseline to Month 36 Month 18; n=24, 20, 17	69.4 percentage score on a scale Standard Deviation 14.3	75.8 percentage score on a scale Standard Deviation 12.8	74.0 percentage score on a scale Standard Deviation 11.9	—
Schwab and England Scale: Best "On" Period Stage From Baseline to Month 36 Month 24; n=23, 18, 15	68.0 percentage score on a scale Standard Deviation 15.2	72.2 percentage score on a scale Standard Deviation 18.1	73.3 percentage score on a scale Standard Deviation 14.6	—
Schwab and England Scale: Best "On" Period Stage From Baseline to Month 36 Month 30; n=23, 17, 13	67.7 percentage score on a scale Standard Deviation 17.9	70.4 percentage score on a scale Standard Deviation 18.7	71.8 percentage score on a scale Standard Deviation 16.7	—
Schwab and England Scale: Best "On" Period Stage From Baseline to Month 36 Month 36; n=21, 16, 12	64.2 percentage score on a scale Standard Deviation 21.1	66.7 percentage score on a scale Standard Deviation 21.1	73.1 percentage score on a scale Standard Deviation 13.0	—
Schwab and England Scale: Best "On" Period Stage From Baseline to Month 36 Endpoint; n=27, 22, 18	62.2 percentage score on a scale Standard Deviation 17.7	68.9 percentage score on a scale Standard Deviation 19.5	71.4 percentage score on a scale Standard Deviation 13.2	—

SECONDARY outcome

Timeframe: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint visit (Month 36 or last visit if discontinued early)

The MMSE is used to assess orientation, attention, immediate and short term recall, language, and ability to follow simple verbal and written commands. The test consists of five sections (orientation, registration, attention-calculation, recall, and language) and results in a total possible score of 0 to 30, with higher scores indicating better function.

Outcome measures

Outcome measures
Measure	Duodopa Non-naïve ≥ 2 Years n=18 Participants Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Duodopa Naïve n=27 Participants Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Duodopa Non-naïve < 2 Years n=22 Participants Duodopa non-naïve participants treated with Duodopa for \< 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Total All participants
Mini Mental Status Examination (MMSE) Total Scores From Baseline to Month 36 Baseline (Month -3); n=26, 0, 0	NA units on a scale Standard Deviation NA Baseline for Duodopa non-naive participants was not done.	28.2 units on a scale Standard Deviation 2.2	NA units on a scale Standard Deviation NA Baseline for Duodopa non-naive participants was not done.	—
Mini Mental Status Examination (MMSE) Total Scores From Baseline to Month 36 Month 0; n=27, 22, 18	28.2 units on a scale Standard Deviation 1.4	27.8 units on a scale Standard Deviation 2.4	28.0 units on a scale Standard Deviation 2.2	—
Mini Mental Status Examination (MMSE) Total Scores From Baseline to Month 36 Month 9; n=25, 20, 17	28.3 units on a scale Standard Deviation 2.1	28.4 units on a scale Standard Deviation 2.3	27.6 units on a scale Standard Deviation 2.0	—
Mini Mental Status Examination (MMSE) Total Scores From Baseline to Month 36 Endpoint; n=27, 22, 17	27.3 units on a scale Standard Deviation 3.8	27.1 units on a scale Standard Deviation 3.9	26.4 units on a scale Standard Deviation 3.8	—
Mini Mental Status Examination (MMSE) Total Scores From Baseline to Month 36 Month 3; n=24, 22, 18	28.6 units on a scale Standard Deviation 1.9	28.0 units on a scale Standard Deviation 2.9	27.2 units on a scale Standard Deviation 2.8	—
Mini Mental Status Examination (MMSE) Total Scores From Baseline to Month 36 Month 6; n=25, 21, 18	28.1 units on a scale Standard Deviation 1.4	28.1 units on a scale Standard Deviation 2.5	27.6 units on a scale Standard Deviation 1.9	—
Mini Mental Status Examination (MMSE) Total Scores From Baseline to Month 36 Month 12; n=25, 20, 17	28.2 units on a scale Standard Deviation 2.5	27.9 units on a scale Standard Deviation 2.8	28.2 units on a scale Standard Deviation 1.7	—
Mini Mental Status Examination (MMSE) Total Scores From Baseline to Month 36 Month 18; n=24, 19, 16	28.3 units on a scale Standard Deviation 2.3	27.6 units on a scale Standard Deviation 2.7	28.5 units on a scale Standard Deviation 1.4	—
Mini Mental Status Examination (MMSE) Total Scores From Baseline to Month 36 Month 24; n=23, 18, 15	28.0 units on a scale Standard Deviation 2.2	27.7 units on a scale Standard Deviation 2.5	27.8 units on a scale Standard Deviation 2.0	—
Mini Mental Status Examination (MMSE) Total Scores From Baseline to Month 36 Month 30; n=23, 17, 13	28.6 units on a scale Standard Deviation 2.0	27.3 units on a scale Standard Deviation 3.9	26.4 units on a scale Standard Deviation 3.4	—
Mini Mental Status Examination (MMSE) Total Scores From Baseline to Month 36 Month 36; n=21, 16, 12	27.9 units on a scale Standard Deviation 4.1	27.2 units on a scale Standard Deviation 3.2	26.3 units on a scale Standard Deviation 4.0	—

SECONDARY outcome

Timeframe: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)

The MMSE is used to assess orientation, attention, immediate and short term recall, language, and ability to follow simple verbal and written commands. The orientation subscale has a total possible score of 0 to 10, with higher scores indicating better function.

Outcome measures

Outcome measures
Measure	Duodopa Non-naïve ≥ 2 Years n=18 Participants Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Duodopa Naïve n=27 Participants Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Duodopa Non-naïve < 2 Years n=22 Participants Duodopa non-naïve participants treated with Duodopa for \< 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Total All participants
MMSE Orientation Subscale Scores From Baseline to Month 36 Month 9; n=25, 20, 17	9.6 units on a scale Standard Deviation 1.0	9.8 units on a scale Standard Deviation 0.5	9.9 units on a scale Standard Deviation 0.4	—
MMSE Orientation Subscale Scores From Baseline to Month 36 Month 12; n=25, 20, 17	9.7 units on a scale Standard Deviation 1.0	9.6 units on a scale Standard Deviation 1.1	9.8 units on a scale Standard Deviation 0.6	—
MMSE Orientation Subscale Scores From Baseline to Month 36 Month 36; n=21, 16, 12	9.1 units on a scale Standard Deviation 2.2	9.6 units on a scale Standard Deviation 1.0	9.3 units on a scale Standard Deviation 1.2	—
MMSE Orientation Subscale Scores From Baseline to Month 36 Endpoint; n=27, 22, 17	9.2 units on a scale Standard Deviation 1.8	9.5 units on a scale Standard Deviation 1.1	8.9 units on a scale Standard Deviation 1.6	—
MMSE Orientation Subscale Scores From Baseline to Month 36 Baseline (Month -3); n=26, 0, 0	NA units on a scale Standard Deviation NA Baseline for Duodopa non-naive participants was not done.	9.8 units on a scale Standard Deviation 0.6	NA units on a scale Standard Deviation NA Baseline for Duodopa non-naive participants was not done.	—
MMSE Orientation Subscale Scores From Baseline to Month 36 Month 0; n=27, 22, 18	9.8 units on a scale Standard Deviation 0.4	9.6 units on a scale Standard Deviation 1.1	9.9 units on a scale Standard Deviation 0.4	—
MMSE Orientation Subscale Scores From Baseline to Month 36 Month 3; n=24, 22, 18	9.6 units on a scale Standard Deviation 0.6	9.4 units on a scale Standard Deviation 1.2	9.5 units on a scale Standard Deviation 1.1	—
MMSE Orientation Subscale Scores From Baseline to Month 36 Month 6; n=25, 21, 18	9.7 units on a scale Standard Deviation 0.6	9.7 units on a scale Standard Deviation 0.7	9.6 units on a scale Standard Deviation 0.9	—
MMSE Orientation Subscale Scores From Baseline to Month 36 Month 18; n=24, 19, 16	9.9 units on a scale Standard Deviation 0.3	9.7 units on a scale Standard Deviation 0.7	9.7 units on a scale Standard Deviation 0.6	—
MMSE Orientation Subscale Scores From Baseline to Month 36 Month 24; n=23, 18, 15	9.9 units on a scale Standard Deviation 0.4	9.7 units on a scale Standard Deviation 0.6	9.8 units on a scale Standard Deviation 0.5	—
MMSE Orientation Subscale Scores From Baseline to Month 36 Month 30; n=23, 17, 13	9.8 units on a scale Standard Deviation 0.6	9.4 units on a scale Standard Deviation 1.2	8.9 units on a scale Standard Deviation 1.9	—

SECONDARY outcome

Timeframe: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)

The MMSE is used to assess orientation, attention, immediate and short term recall, language, and ability to follow simple verbal and written commands. The Registration subscale a total possible score of 0 to 3, with higher scores indicating better function.

Outcome measures

Outcome measures
Measure	Duodopa Non-naïve ≥ 2 Years n=18 Participants Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Duodopa Naïve n=27 Participants Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Duodopa Non-naïve < 2 Years n=22 Participants Duodopa non-naïve participants treated with Duodopa for \< 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Total All participants
MMSE Registration Subscale Scores From Baseline to Month 36 Baseline (Month -3); n=26, 0, 0	NA units on a scale Standard Deviation NA Baseline for Duodopa non-naive participants was not done.	3.0 units on a scale Standard Deviation 0.0	NA units on a scale Standard Deviation NA Baseline for Duodopa non-naive participants was not done.	—
MMSE Registration Subscale Scores From Baseline to Month 36 Month 0; n=27, 22, 18	3.0 units on a scale Standard Deviation 0.0	3.0 units on a scale Standard Deviation 0.2	3.0 units on a scale Standard Deviation 0.2	—
MMSE Registration Subscale Scores From Baseline to Month 36 Month 3; n=24, 22, 18	3.0 units on a scale Standard Deviation 0.0	3.0 units on a scale Standard Deviation 0.0	3.0 units on a scale Standard Deviation 0.2	—
MMSE Registration Subscale Scores From Baseline to Month 36 Month 6; n=25, 21, 18	3.0 units on a scale Standard Deviation 0.0	3.0 units on a scale Standard Deviation 0.0	3.0 units on a scale Standard Deviation 0.0	—
MMSE Registration Subscale Scores From Baseline to Month 36 Month 9; n=25, 20, 17	3.0 units on a scale Standard Deviation 0.0	3.0 units on a scale Standard Deviation 0.0	3.0 units on a scale Standard Deviation 0.0	—
MMSE Registration Subscale Scores From Baseline to Month 36 Month 12; n=25, 20, 17	3.0 units on a scale Standard Deviation 0.0	3.0 units on a scale Standard Deviation 0.2	3.0 units on a scale Standard Deviation 0.0	—
MMSE Registration Subscale Scores From Baseline to Month 36 Month 18; n=24, 19, 16	3.0 units on a scale Standard Deviation 0.0	3.0 units on a scale Standard Deviation 0.0	3.0 units on a scale Standard Deviation 0.0	—
MMSE Registration Subscale Scores From Baseline to Month 36 Month 24; n=23, 18, 15	3.0 units on a scale Standard Deviation 0.0	3.0 units on a scale Standard Deviation 0.2	3.0 units on a scale Standard Deviation 0.0	—
MMSE Registration Subscale Scores From Baseline to Month 36 Month 30; n=23, 17, 13	3.0 units on a scale Standard Deviation 0.0	3.0 units on a scale Standard Deviation 0.0	2.9 units on a scale Standard Deviation 0.2	—
MMSE Registration Subscale Scores From Baseline to Month 36 Month 36; n=21, 16, 12	2.9 units on a scale Standard Deviation 0.3	3.0 units on a scale Standard Deviation 0.0	3.0 units on a scale Standard Deviation 0.0	—
MMSE Registration Subscale Scores From Baseline to Month 36 Endpoint; n=27, 22, 17	2.9 units on a scale Standard Deviation 0.2	3.0 units on a scale Standard Deviation 0.0	3.0 units on a scale Standard Deviation 0.0	—

SECONDARY outcome

Timeframe: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)

The MMSE is used to assess orientation, attention, immediate and short term recall, language, and ability to follow simple verbal and written commands. The Attention and Calculation subscale results in a total possible score of 0 to 5, with higher scores indicating better function.

Outcome measures

Outcome measures
Measure	Duodopa Non-naïve ≥ 2 Years n=18 Participants Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Duodopa Naïve n=27 Participants Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Duodopa Non-naïve < 2 Years n=22 Participants Duodopa non-naïve participants treated with Duodopa for \< 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Total All participants
MMSE Attention and Calculation Subscale Scores From Baseline to Month 36 Month 30; n=23, 17, 13	4.8 units on a scale Standard Deviation 0.4	4.6 units on a scale Standard Deviation 1.0	4.1 units on a scale Standard Deviation 1.2	—
MMSE Attention and Calculation Subscale Scores From Baseline to Month 36 Baseline (Month -3); n=26, 0, 0	NA units on a scale Standard Deviation NA Baseline for Duodopa non-naive participants was not done.	4.9 units on a scale Standard Deviation 0.4	NA units on a scale Standard Deviation NA Baseline for Duodopa non-naive participants was not done.	—
MMSE Attention and Calculation Subscale Scores From Baseline to Month 36 Month 0; n=27, 22, 18	4.6 units on a scale Standard Deviation 0.7	4.6 units on a scale Standard Deviation 0.9	4.4 units on a scale Standard Deviation 1.4	—
MMSE Attention and Calculation Subscale Scores From Baseline to Month 36 Month 3; n=24, 22, 18	4.7 units on a scale Standard Deviation 0.8	4.6 units on a scale Standard Deviation 0.9	4.3 units on a scale Standard Deviation 1.3	—
MMSE Attention and Calculation Subscale Scores From Baseline to Month 36 Month 6; n=25, 21, 18	4.7 units on a scale Standard Deviation 0.6	4.6 units on a scale Standard Deviation 1.0	4.5 units on a scale Standard Deviation 0.8	—
MMSE Attention and Calculation Subscale Scores From Baseline to Month 36 Month 9; n=25, 20, 17	4.8 units on a scale Standard Deviation 0.5	4.7 units on a scale Standard Deviation 0.6	4.3 units on a scale Standard Deviation 1.0	—
MMSE Attention and Calculation Subscale Scores From Baseline to Month 36 Month 12; n=25, 20, 17	4.6 units on a scale Standard Deviation 0.7	4.7 units on a scale Standard Deviation 0.6	4.7 units on a scale Standard Deviation 0.7	—
MMSE Attention and Calculation Subscale Scores From Baseline to Month 36 Month 18; n=24, 19, 16	4.5 units on a scale Standard Deviation 1.1	4.5 units on a scale Standard Deviation 1.1	4.7 units on a scale Standard Deviation 0.8	—
MMSE Attention and Calculation Subscale Scores From Baseline to Month 36 Month 24; n=23, 18, 15	4.3 units on a scale Standard Deviation 1.2	4.6 units on a scale Standard Deviation 0.7	4.6 units on a scale Standard Deviation 0.6	—
MMSE Attention and Calculation Subscale Scores From Baseline to Month 36 Month 36; n=21, 16, 12	4.8 units on a scale Standard Deviation 0.6	4.2 units on a scale Standard Deviation 1.5	3.7 units on a scale Standard Deviation 1.9	—
MMSE Attention and Calculation Subscale Scores From Baseline to Month 36 Endpoint; n=27, 22, 17	4.4 units on a scale Standard Deviation 0.9	4.2 units on a scale Standard Deviation 1.5	4.0 units on a scale Standard Deviation 1.7	—

SECONDARY outcome

Timeframe: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)

The MMSE is used to assess orientation, attention, immediate and short term recall, language, and ability to follow simple verbal and written commands. The Recall subscale results in a total possible score of 0 to 3, with higher scores indicating better function.

Outcome measures

Outcome measures
Measure	Duodopa Non-naïve ≥ 2 Years n=18 Participants Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Duodopa Naïve n=27 Participants Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Duodopa Non-naïve < 2 Years n=22 Participants Duodopa non-naïve participants treated with Duodopa for \< 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Total All participants
MMSE Recall Subscale Scores From Baseline to Month 36 Month 36; n=21, 16, 12	2.8 units on a scale Standard Deviation 0.5	2.2 units on a scale Standard Deviation 0.9	2.4 units on a scale Standard Deviation 0.7	—
MMSE Recall Subscale Scores From Baseline to Month 36 Endpoint; n=27, 22, 17	2.5 units on a scale Standard Deviation 0.8	2.2 units on a scale Standard Deviation 0.9	2.5 units on a scale Standard Deviation 0.7	—
MMSE Recall Subscale Scores From Baseline to Month 36 Baseline (Month -3); n=26, 0, 0	NA units on a scale Standard Deviation NA Baseline for Duodopa non-naive participants was not done.	2.2 units on a scale Standard Deviation 0.9	NA units on a scale Standard Deviation NA Baseline for Duodopa non-naive participants was not done.	—
MMSE Recall Subscale Scores From Baseline to Month 36 Month 0; n=27, 22, 18	2.3 units on a scale Standard Deviation 0.8	2.2 units on a scale Standard Deviation 1.0	2.1 units on a scale Standard Deviation 0.8	—
MMSE Recall Subscale Scores From Baseline to Month 36 Month 3; n=24, 22, 18	2.5 units on a scale Standard Deviation 0.6	2.5 units on a scale Standard Deviation 0.9	2.1 units on a scale Standard Deviation 0.9	—
MMSE Recall Subscale Scores From Baseline to Month 36 Month 6; n=25, 21, 18	2.3 units on a scale Standard Deviation 0.8	2.5 units on a scale Standard Deviation 0.8	2.4 units on a scale Standard Deviation 0.8	—
MMSE Recall Subscale Scores From Baseline to Month 36 Month 9; n=25, 20, 17	2.5 units on a scale Standard Deviation 0.9	2.5 units on a scale Standard Deviation 0.8	2.2 units on a scale Standard Deviation 0.8	—
MMSE Recall Subscale Scores From Baseline to Month 36 Month 12; n=25, 20, 17	2.6 units on a scale Standard Deviation 0.9	2.5 units on a scale Standard Deviation 0.9	2.5 units on a scale Standard Deviation 0.8	—
MMSE Recall Subscale Scores From Baseline to Month 36 Month 18; n=24, 19, 16	2.6 units on a scale Standard Deviation 0.9	2.3 units on a scale Standard Deviation 0.7	2.5 units on a scale Standard Deviation 0.5	—
MMSE Recall Subscale Scores From Baseline to Month 36 Month 24; n=23, 18, 15	2.5 units on a scale Standard Deviation 0.9	2.4 units on a scale Standard Deviation 0.8	2.3 units on a scale Standard Deviation 0.8	—
MMSE Recall Subscale Scores From Baseline to Month 36 Month 30; n=23, 17, 13	2.6 units on a scale Standard Deviation 0.8	2.5 units on a scale Standard Deviation 0.9	2.5 units on a scale Standard Deviation 0.6	—

SECONDARY outcome

Timeframe: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)

The MMSE is used to assess orientation, attention, immediate and short term recall, language, and ability to follow simple verbal and written commands. The Language subscale results in a total possible score of 0 to 9, with higher scores indicating better function.

Outcome measures

Outcome measures
Measure	Duodopa Non-naïve ≥ 2 Years n=18 Participants Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Duodopa Naïve n=27 Participants Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Duodopa Non-naïve < 2 Years n=22 Participants Duodopa non-naïve participants treated with Duodopa for \< 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Total All participants
MMSE Language Subscale Scores From Baseline to Month 36 Baseline (Month -3); n=26, 0, 0	NA units on a scale Standard Deviation NA Baseline for Duodopa non-naive participants was not done.	8.3 units on a scale Standard Deviation 1.6	NA units on a scale Standard Deviation NA Baseline for Duodopa non-naive participants was not done.	—
MMSE Language Subscale Scores From Baseline to Month 36 Month 0; n=27, 22, 18	8.5 units on a scale Standard Deviation 0.7	8.5 units on a scale Standard Deviation 0.9	8.6 units on a scale Standard Deviation 0.5	—
MMSE Language Subscale Scores From Baseline to Month 36 Month 3; n=24, 22, 18	8.7 units on a scale Standard Deviation 0.5	8.4 units on a scale Standard Deviation 0.7	8.3 units on a scale Standard Deviation 0.9	—
MMSE Language Subscale Scores From Baseline to Month 36 Month 6; n=25, 21, 18	8.3 units on a scale Standard Deviation 0.7	8.3 units on a scale Standard Deviation 0.9	8.1 units on a scale Standard Deviation 1.3	—
MMSE Language Subscale Scores From Baseline to Month 36 Month 9; n=25, 20, 17	8.4 units on a scale Standard Deviation 0.7	8.4 units on a scale Standard Deviation 1.0	8.2 units on a scale Standard Deviation 0.9	—
MMSE Language Subscale Scores From Baseline to Month 36 Month 12; n=25, 20, 17	8.2 units on a scale Standard Deviation 0.8	8.2 units on a scale Standard Deviation 1.3	8.3 units on a scale Standard Deviation 0.7	—
MMSE Language Subscale Scores From Baseline to Month 36 Month 18; n=24, 19, 16	8.3 units on a scale Standard Deviation 0.9	8.2 units on a scale Standard Deviation 1.1	8.6 units on a scale Standard Deviation 0.6	—
MMSE Language Subscale Scores From Baseline to Month 36 Month 24; n=23, 18, 15	8.3 units on a scale Standard Deviation 0.8	8.0 units on a scale Standard Deviation 1.4	8.1 units on a scale Standard Deviation 0.9	—
MMSE Language Subscale Scores From Baseline to Month 36 Month 30; n=23, 17, 13	8.5 units on a scale Standard Deviation 1.0	7.9 units on a scale Standard Deviation 1.4	8.0 units on a scale Standard Deviation 0.9	—
MMSE Language Subscale Scores From Baseline to Month 36 Month 36; n=21, 16, 12	8.4 units on a scale Standard Deviation 1.0	8.3 units on a scale Standard Deviation 0.9	7.9 units on a scale Standard Deviation 1.3	—
MMSE Language Subscale Scores From Baseline to Month 36 Endpoint; n=27, 22, 17	8.4 units on a scale Standard Deviation 1.0	8.3 units on a scale Standard Deviation 0.9	7.9 units on a scale Standard Deviation 1.3	—

SECONDARY outcome

Timeframe: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)

MADRS is a depression rating scale consisting of 10 items representing the core symptoms of depressive illness, each rated 0 (no symptom) to 6 (severe symptom). Total score ranges from 0 (no depression) to 60 (severely depressed).

Outcome measures

Outcome measures
Measure	Duodopa Non-naïve ≥ 2 Years n=28 Participants Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Duodopa Naïve n=27 Participants Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Duodopa Non-naïve < 2 Years n=22 Participants Duodopa non-naïve participants treated with Duodopa for \< 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Total All participants
Montgomery-Åsberg Depression Rating Scale (MADRS) Total Scores From Baseline to Month 36 Month 12; n=25, 20, 17	9.5 units on a scale Standard Deviation 7.3	8.6 units on a scale Standard Deviation 5.7	8.8 units on a scale Standard Deviation 5.2	—
Montgomery-Åsberg Depression Rating Scale (MADRS) Total Scores From Baseline to Month 36 Baseline (Month -3); n=26, 0, 0	NA units on a scale Standard Deviation NA Baseline for Duodopa non-naive participants was not done.	10.3 units on a scale Standard Deviation 5.6	NA units on a scale Standard Deviation NA Baseline for Duodopa non-naive participants was not done.	—
Montgomery-Åsberg Depression Rating Scale (MADRS) Total Scores From Baseline to Month 36 Month 0; n=27, 22, 18	8.8 units on a scale Standard Deviation 5.8	9.0 units on a scale Standard Deviation 5.3	7.8 units on a scale Standard Deviation 5.2	—
Montgomery-Åsberg Depression Rating Scale (MADRS) Total Scores From Baseline to Month 36 Month 3; n=24, 22, 17	8.4 units on a scale Standard Deviation 5.8	10.2 units on a scale Standard Deviation 6.3	8.1 units on a scale Standard Deviation 4.9	—
Montgomery-Åsberg Depression Rating Scale (MADRS) Total Scores From Baseline to Month 36 Month 6; n=25, 21, 17	8.5 units on a scale Standard Deviation 5.3	10.5 units on a scale Standard Deviation 6.9	8.4 units on a scale Standard Deviation 3.8	—
Montgomery-Åsberg Depression Rating Scale (MADRS) Total Scores From Baseline to Month 36 Month 9; n=25, 20, 17	9.9 units on a scale Standard Deviation 6.5	8.8 units on a scale Standard Deviation 4.9	8.0 units on a scale Standard Deviation 3.4	—
Montgomery-Åsberg Depression Rating Scale (MADRS) Total Scores From Baseline to Month 36 Month 18; n=24, 19, 16	9.1 units on a scale Standard Deviation 7.1	10.6 units on a scale Standard Deviation 6.2	8.1 units on a scale Standard Deviation 4.5	—
Montgomery-Åsberg Depression Rating Scale (MADRS) Total Scores From Baseline to Month 36 Month 24; n=23, 18, 15	11.1 units on a scale Standard Deviation 7.4	10.1 units on a scale Standard Deviation 5.6	9.7 units on a scale Standard Deviation 5.5	—
Montgomery-Åsberg Depression Rating Scale (MADRS) Total Scores From Baseline to Month 36 Month 30; n=22, 17, 13	9.0 units on a scale Standard Deviation 5.0	12.0 units on a scale Standard Deviation 5.9	10.6 units on a scale Standard Deviation 4.6	—
Montgomery-Åsberg Depression Rating Scale (MADRS) Total Scores From Baseline to Month 36 Month 36; n=21, 16, 12	10.4 units on a scale Standard Deviation 9.4	12.2 units on a scale Standard Deviation 7.3	9.1 units on a scale Standard Deviation 4.5	—
Montgomery-Åsberg Depression Rating Scale (MADRS) Total Scores From Baseline to Month 36 Endpoint; n=26, 22, 17	12.3 units on a scale Standard Deviation 9.1	11.6 units on a scale Standard Deviation 7.0	9.0 units on a scale Standard Deviation 4.9	—

SECONDARY outcome

Timeframe: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)

MADRS is a depression rating scale consisting of 10 items representing the core symptoms of depressive illness, each rated 0 (no symptom) to 6 (severe symptom). Reported Sadness scores rate depressed mood, regardless of whether it is reflected in appearance or not, and includes low spirits, despondency or the feeling of being beyond help and without hope.

Outcome measures

Outcome measures
Measure	Duodopa Non-naïve ≥ 2 Years n=18 Participants Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Duodopa Naïve n=27 Participants Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Duodopa Non-naïve < 2 Years n=22 Participants Duodopa non-naïve participants treated with Duodopa for \< 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Total All participants
MADRS Reported Sadness Scores From Baseline to Month 36 Baseline (Month -3); n=26, 0, 0	NA units on a scale Standard Deviation NA Baseline for Duodopa non-naive participants was not done.	0.9 units on a scale Standard Deviation 0.8	NA units on a scale Standard Deviation NA Baseline for Duodopa non-naive participants was not done.	—
MADRS Reported Sadness Scores From Baseline to Month 36 Month 0; n=27, 22, 18	0.8 units on a scale Standard Deviation 1.0	0.6 units on a scale Standard Deviation 0.7	0.8 units on a scale Standard Deviation 1.2	—
MADRS Reported Sadness Scores From Baseline to Month 36 Month 3; n=24, 22, 17	0.5 units on a scale Standard Deviation 0.6	0.9 units on a scale Standard Deviation 1.0	0.6 units on a scale Standard Deviation 0.8	—
MADRS Reported Sadness Scores From Baseline to Month 36 Month 6; n=25, 21, 17	0.5 units on a scale Standard Deviation 0.7	1.1 units on a scale Standard Deviation 1.1	0.8 units on a scale Standard Deviation 0.6	—
MADRS Reported Sadness Scores From Baseline to Month 36 Month 9; n=25, 20, 17	1.1 units on a scale Standard Deviation 1.4	0.9 units on a scale Standard Deviation 0.7	0.9 units on a scale Standard Deviation 0.8	—
MADRS Reported Sadness Scores From Baseline to Month 36 Month 12; n=25, 20, 17	0.8 units on a scale Standard Deviation 1.0	0.6 units on a scale Standard Deviation 0.7	1.1 units on a scale Standard Deviation 0.9	—
MADRS Reported Sadness Scores From Baseline to Month 36 Month 18; n=24, 19, 16	0.8 units on a scale Standard Deviation 0.8	1.0 units on a scale Standard Deviation 1.0	0.7 units on a scale Standard Deviation 0.7	—
MADRS Reported Sadness Scores From Baseline to Month 36 Month 24; n=23, 18, 15	0.8 units on a scale Standard Deviation 0.7	1.0 units on a scale Standard Deviation 1.0	0.9 units on a scale Standard Deviation 0.9	—
MADRS Reported Sadness Scores From Baseline to Month 36 Month 30; n=23, 17, 13	0.9 units on a scale Standard Deviation 1.0	1.2 units on a scale Standard Deviation 0.9	0.9 units on a scale Standard Deviation 0.8	—
MADRS Reported Sadness Scores From Baseline to Month 36 Month 36; n=21, 16, 12	1.1 units on a scale Standard Deviation 1.1	1.1 units on a scale Standard Deviation 1.2	0.9 units on a scale Standard Deviation 0.9	—
MADRS Reported Sadness Scores From Baseline to Month 36 Endpoint; n=27, 22, 17	1.0 units on a scale Standard Deviation 1.0	1.2 units on a scale Standard Deviation 1.2	0.8 units on a scale Standard Deviation 0.9	—

SECONDARY outcome

Timeframe: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)

MADRS is a depression rating scale consisting of 10 items representing the core symptoms of depressive illness, each rated 0 (no symptom) to 6 (severe symptom). Apparent sadness scores rate despondency, gloom and despair (more than just ordinary transient low spirits), reflected in speech, facial expression, and posture.

Outcome measures

Outcome measures
Measure	Duodopa Non-naïve ≥ 2 Years n=18 Participants Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Duodopa Naïve n=27 Participants Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Duodopa Non-naïve < 2 Years n=22 Participants Duodopa non-naïve participants treated with Duodopa for \< 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Total All participants
MADRS Apparent Sadness Scores From Baseline to Month 36 Month 3; n=24, 22, 17	0.5 units on a scale Standard Deviation 0.7	0.8 units on a scale Standard Deviation 0.9	0.6 units on a scale Standard Deviation 0.8	—
MADRS Apparent Sadness Scores From Baseline to Month 36 Month 9; n=25, 20, 17	0.9 units on a scale Standard Deviation 1.0	0.9 units on a scale Standard Deviation 0.8	0.7 units on a scale Standard Deviation 0.7	—
MADRS Apparent Sadness Scores From Baseline to Month 36 Month 18; n=24, 19, 16	0.8 units on a scale Standard Deviation 0.9	0.8 units on a scale Standard Deviation 0.9	0.6 units on a scale Standard Deviation 0.7	—
MADRS Apparent Sadness Scores From Baseline to Month 36 Month 30; n=23, 17, 13	0.6 units on a scale Standard Deviation 0.7	1.2 units on a scale Standard Deviation 1.0	1.0 units on a scale Standard Deviation 0.9	—
MADRS Apparent Sadness Scores From Baseline to Month 36 Month 24; n=23, 18, 15	0.7 units on a scale Standard Deviation 0.6	1.0 units on a scale Standard Deviation 1.2	0.6 units on a scale Standard Deviation 0.7	—
MADRS Apparent Sadness Scores From Baseline to Month 36 Month 36; n=21, 16, 12	1.3 units on a scale Standard Deviation 1.4	1.1 units on a scale Standard Deviation 1.2	0.8 units on a scale Standard Deviation 0.9	—
MADRS Apparent Sadness Scores From Baseline to Month 36 Baseline (Month -3); n=26, 0, 0	NA units on a scale Standard Deviation NA Baseline for Duodopa non-naive participants was not done.	0.7 units on a scale Standard Deviation 0.8	NA units on a scale Standard Deviation NA Baseline for Duodopa non-naive participants was not done.	—
MADRS Apparent Sadness Scores From Baseline to Month 36 Month 0; n=27, 22, 18	0.8 units on a scale Standard Deviation 0.7	0.4 units on a scale Standard Deviation 0.8	0.5 units on a scale Standard Deviation 0.9	—
MADRS Apparent Sadness Scores From Baseline to Month 36 Month 6; n=25, 21, 17	0.5 units on a scale Standard Deviation 0.6	1.0 units on a scale Standard Deviation 1.1	0.6 units on a scale Standard Deviation 0.5	—
MADRS Apparent Sadness Scores From Baseline to Month 36 Month 12; n=25, 20, 17	0.8 units on a scale Standard Deviation 0.8	0.4 units on a scale Standard Deviation 0.5	0.9 units on a scale Standard Deviation 1.0	—
MADRS Apparent Sadness Scores From Baseline to Month 36 Endpoint; n=27, 22, 17	1.0 units on a scale Standard Deviation 1.2	1.1 units on a scale Standard Deviation 1.2	0.8 units on a scale Standard Deviation 1.0	—

SECONDARY outcome

Timeframe: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)

MADRS is a depression rating scale consisting of 10 items representing the core symptoms of depressive illness, each rated 0 (no symptom) to 6 (severe symptom). Inner Tension scores rate feelings of ill-defined discomfort, edginess, inner turmoil, mental tension mounting to either panic, dread or anguish.

Outcome measures

Outcome measures
Measure	Duodopa Non-naïve ≥ 2 Years n=18 Participants Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Duodopa Naïve n=27 Participants Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Duodopa Non-naïve < 2 Years n=22 Participants Duodopa non-naïve participants treated with Duodopa for \< 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Total All participants
MADRS Inner Tension Scores From Baseline to Month 36 Month 12; n=25, 20, 17	1.5 units on a scale Standard Deviation 1.0	1.1 units on a scale Standard Deviation 1.1	0.7 units on a scale Standard Deviation 0.9	—
MADRS Inner Tension Scores From Baseline to Month 36 Baseline (Month -3); n=26, 0, 0	NA units on a scale Standard Deviation NA Baseline for Duodopa non-naive participants was not done.	1.3 units on a scale Standard Deviation 1.3	NA units on a scale Standard Deviation NA Baseline for Duodopa non-naive participants was not done.	—
MADRS Inner Tension Scores From Baseline to Month 36 Month 0; n=27, 22, 18	0.9 units on a scale Standard Deviation 1.0	1.3 units on a scale Standard Deviation 1.1	1.0 units on a scale Standard Deviation 1.0	—
MADRS Inner Tension Scores From Baseline to Month 36 Month 3; n=24, 22, 17	0.9 units on a scale Standard Deviation 1.0	1.5 units on a scale Standard Deviation 1.3	0.8 units on a scale Standard Deviation 1.0	—
MADRS Inner Tension Scores From Baseline to Month 36 Month 6; n=25, 21, 17	1.2 units on a scale Standard Deviation 1.1	1.1 units on a scale Standard Deviation 1.1	0.9 units on a scale Standard Deviation 1.0	—
MADRS Inner Tension Scores From Baseline to Month 36 Month 9; n=25, 20, 17	0.9 units on a scale Standard Deviation 1.1	0.9 units on a scale Standard Deviation 1.2	0.6 units on a scale Standard Deviation 0.8	—
MADRS Inner Tension Scores From Baseline to Month 36 Month 18; n=24, 19, 16	0.8 units on a scale Standard Deviation 1.0	1.2 units on a scale Standard Deviation 1.1	0.7 units on a scale Standard Deviation 0.9	—
MADRS Inner Tension Scores From Baseline to Month 36 Month 24; n=23, 18, 15	1.3 units on a scale Standard Deviation 1.3	1.0 units on a scale Standard Deviation 1.1	0.8 units on a scale Standard Deviation 1.1	—
MADRS Inner Tension Scores From Baseline to Month 36 Month 30; n=23, 17, 13	1.5 units on a scale Standard Deviation 1.1	1.1 units on a scale Standard Deviation 1.1	1.1 units on a scale Standard Deviation 1.2	—
MADRS Inner Tension Scores From Baseline to Month 36 Month 36; n=21, 16, 12	1.3 units on a scale Standard Deviation 1.2	1.7 units on a scale Standard Deviation 1.2	0.6 units on a scale Standard Deviation 0.8	—
MADRS Inner Tension Scores From Baseline to Month 36 Endpoint; n=27, 22, 17	1.5 units on a scale Standard Deviation 1.3	1.6 units on a scale Standard Deviation 1.1	0.6 units on a scale Standard Deviation 0.8	—

SECONDARY outcome

Timeframe: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)

MADRS is a depression rating scale consisting of 10 items representing the core symptoms of depressive illness, each rated 0 (no symptom) to 6 (severe symptom). Reduced Sleep scores rate the experience of reduced duration or depth of sleep compared to the participant's own normal pattern when well.

Outcome measures

Outcome measures
Measure	Duodopa Non-naïve ≥ 2 Years n=18 Participants Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Duodopa Naïve n=27 Participants Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Duodopa Non-naïve < 2 Years n=22 Participants Duodopa non-naïve participants treated with Duodopa for \< 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Total All participants
MADRS Reduced Sleep Scores From Baseline to Month 36 Month 24; n=23, 18, 15	1.5 units on a scale Standard Deviation 1.7	1.6 units on a scale Standard Deviation 1.3	1.8 units on a scale Standard Deviation 1.9	—
MADRS Reduced Sleep Scores From Baseline to Month 36 Endpoint; n=27, 22, 17	2.0 units on a scale Standard Deviation 2.2	1.6 units on a scale Standard Deviation 1.7	1.4 units on a scale Standard Deviation 1.5	—
MADRS Reduced Sleep Scores From Baseline to Month 36 Baseline (Month -3); n=26, 0, 0	NA units on a scale Standard Deviation NA Baseline for Duodopa non-naive participants was not done.	2.5 units on a scale Standard Deviation 1.7	NA units on a scale Standard Deviation NA Baseline for Duodopa non-naive participants was not done.	—
MADRS Reduced Sleep Scores From Baseline to Month 36 Month 0; n=27, 22, 18	1.7 units on a scale Standard Deviation 1.8	1.9 units on a scale Standard Deviation 1.6	1.5 units on a scale Standard Deviation 1.6	—
MADRS Reduced Sleep Scores From Baseline to Month 36 Month 3; n=24, 22, 17	1.2 units on a scale Standard Deviation 1.2	2.0 units on a scale Standard Deviation 1.4	1.8 units on a scale Standard Deviation 1.6	—
MADRS Reduced Sleep Scores From Baseline to Month 36 Month 6; n=25, 21, 17	1.5 units on a scale Standard Deviation 1.7	1.8 units on a scale Standard Deviation 1.8	1.7 units on a scale Standard Deviation 1.5	—
MADRS Reduced Sleep Scores From Baseline to Month 36 Month 9; n=25, 20, 17	1.4 units on a scale Standard Deviation 1.5	1.8 units on a scale Standard Deviation 1.5	1.9 units on a scale Standard Deviation 1.3	—
MADRS Reduced Sleep Scores From Baseline to Month 36 Month 12; n=25, 20, 17	1.2 units on a scale Standard Deviation 1.4	1.8 units on a scale Standard Deviation 1.5	1.5 units on a scale Standard Deviation 1.5	—
MADRS Reduced Sleep Scores From Baseline to Month 36 Month 18; n=24, 19, 16	1.7 units on a scale Standard Deviation 1.4	1.7 units on a scale Standard Deviation 1.3	1.5 units on a scale Standard Deviation 1.5	—
MADRS Reduced Sleep Scores From Baseline to Month 36 Month 30; n=23, 17, 13	0.9 units on a scale Standard Deviation 1.0	2.3 units on a scale Standard Deviation 1.7	1.9 units on a scale Standard Deviation 1.9	—
MADRS Reduced Sleep Scores From Baseline to Month 36 Month 36; n=21, 16, 12	1.2 units on a scale Standard Deviation 1.5	1.9 units on a scale Standard Deviation 1.7	1.2 units on a scale Standard Deviation 1.4	—

SECONDARY outcome

Timeframe: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)

MADRS is a depression rating scale consisting of 10 items representing the core symptoms of depressive illness, each rated 0 (no symptom) to 6 (severe symptom). Reduced Appetite scores rate the feeling of a loss of appetite compared with when-well. Rate by loss of desire for food or the need to force oneself to eat.

Outcome measures

Outcome measures
Measure	Duodopa Non-naïve ≥ 2 Years n=18 Participants Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Duodopa Naïve n=27 Participants Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Duodopa Non-naïve < 2 Years n=22 Participants Duodopa non-naïve participants treated with Duodopa for \< 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Total All participants
MADRS Reduced Appetite Scores From Baseline to Month 36 Baseline (Month -3); n=26, 0, 0	NA units on a scale Standard Deviation NA Baseline for Duodopa non-naive participants was not done.	0.8 units on a scale Standard Deviation 1.1	NA units on a scale Standard Deviation NA Baseline for Duodopa non-naive participants was not done.	—
MADRS Reduced Appetite Scores From Baseline to Month 36 Month 0; n=27, 22, 18	0.3 units on a scale Standard Deviation 0.8	0.6 units on a scale Standard Deviation 0.8	0.2 units on a scale Standard Deviation 0.5	—
MADRS Reduced Appetite Scores From Baseline to Month 36 Month 3; n=24, 22, 17	0.4 units on a scale Standard Deviation 1.0	0.7 units on a scale Standard Deviation 1.0	0.4 units on a scale Standard Deviation 0.8	—
MADRS Reduced Appetite Scores From Baseline to Month 36 Month 6; n=25, 21, 17	0.5 units on a scale Standard Deviation 1.2	0.8 units on a scale Standard Deviation 1.1	0.3 units on a scale Standard Deviation 0.7	—
MADRS Reduced Appetite Scores From Baseline to Month 36 Month 9; n=25, 20, 17	0.8 units on a scale Standard Deviation 1.4	0.5 units on a scale Standard Deviation 0.8	0.4 units on a scale Standard Deviation 0.6	—
MADRS Reduced Appetite Scores From Baseline to Month 36 Month 12; n=25, 20, 17	0.7 units on a scale Standard Deviation 1.2	0.5 units on a scale Standard Deviation 0.8	0.6 units on a scale Standard Deviation 0.8	—
MADRS Reduced Appetite Scores From Baseline to Month 36 Month 18; n=24, 19, 16	0.4 units on a scale Standard Deviation 0.9	0.5 units on a scale Standard Deviation 0.8	0.3 units on a scale Standard Deviation 0.7	—
MADRS Reduced Appetite Scores From Baseline to Month 36 Month 24; n=23, 18, 15	0.7 units on a scale Standard Deviation 1.1	0.7 units on a scale Standard Deviation 1.2	0.5 units on a scale Standard Deviation 0.8	—
MADRS Reduced Appetite Scores From Baseline to Month 36 Month 30; n=23, 17, 13	0.5 units on a scale Standard Deviation 1.1	1.0 units on a scale Standard Deviation 1.2	0.4 units on a scale Standard Deviation 0.6	—
MADRS Reduced Appetite Scores From Baseline to Month 36 Month 36; n=21, 16, 12	1.1 units on a scale Standard Deviation 1.4	0.9 units on a scale Standard Deviation 1.2	0.4 units on a scale Standard Deviation 0.7	—
MADRS Reduced Appetite Scores From Baseline to Month 36 Endpoint; n=27, 22, 17	1.1 units on a scale Standard Deviation 1.3	0.9 units on a scale Standard Deviation 1.2	0.3 units on a scale Standard Deviation 0.6	—

SECONDARY outcome

Timeframe: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)

MADRS is a depression rating scale consisting of 10 items representing the core symptoms of depressive illness, each rated 0 (no symptom) to 6 (severe symptom). Concentration Difficulties scores rate difficulties in collecting one's thoughts mounting to an incapacitating lack of concentration.

Outcome measures

Outcome measures
Measure	Duodopa Non-naïve ≥ 2 Years n=18 Participants Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Duodopa Naïve n=27 Participants Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Duodopa Non-naïve < 2 Years n=22 Participants Duodopa non-naïve participants treated with Duodopa for \< 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Total All participants
MADRS Concentration Difficulties Scores From Baseline to Month 36 Month 12; n=25, 20, 17	1.4 units on a scale Standard Deviation 1.3	0.9 units on a scale Standard Deviation 1.2	1.2 units on a scale Standard Deviation 1.1	—
MADRS Concentration Difficulties Scores From Baseline to Month 36 Baseline (Month -3); n=26, 0, 0	NA units on a scale Standard Deviation NA Baseline for Duodopa non-naive participants was not done.	1.0 units on a scale Standard Deviation 1.0	NA units on a scale Standard Deviation NA Baseline for Duodopa non-naive participants was not done.	—
MADRS Concentration Difficulties Scores From Baseline to Month 36 Month 0; n=27, 22, 18	0.9 units on a scale Standard Deviation 1.2	1.0 units on a scale Standard Deviation 1.2	1.5 units on a scale Standard Deviation 1.3	—
MADRS Concentration Difficulties Scores From Baseline to Month 36 Month 3; n=24, 22, 17	1.2 units on a scale Standard Deviation 1.2	0.9 units on a scale Standard Deviation 1.1	1.3 units on a scale Standard Deviation 0.9	—
MADRS Concentration Difficulties Scores From Baseline to Month 36 Month 6; n=25, 21, 17	1.2 units on a scale Standard Deviation 1.1	1.2 units on a scale Standard Deviation 1.2	1.4 units on a scale Standard Deviation 0.9	—
MADRS Concentration Difficulties Scores From Baseline to Month 36 Month 9; n=25, 20, 17	1.3 units on a scale Standard Deviation 1.2	1.0 units on a scale Standard Deviation 1.2	1.1 units on a scale Standard Deviation 1.1	—
MADRS Concentration Difficulties Scores From Baseline to Month 36 Month 18; n=24, 19, 16	1.4 units on a scale Standard Deviation 1.3	1.5 units on a scale Standard Deviation 1.4	1.4 units on a scale Standard Deviation 1.0	—
MADRS Concentration Difficulties Scores From Baseline to Month 36 Month 24; n=23, 18, 15	1.7 units on a scale Standard Deviation 1.4	1.5 units on a scale Standard Deviation 1.3	1.7 units on a scale Standard Deviation 1.5	—
MADRS Concentration Difficulties Scores From Baseline to Month 36 Month 30; n=23, 17, 13	1.5 units on a scale Standard Deviation 1.5	1.5 units on a scale Standard Deviation 1.7	2.1 units on a scale Standard Deviation 1.1	—
MADRS Concentration Difficulties Scores From Baseline to Month 36 Month 36; n=21, 16, 12	1.2 units on a scale Standard Deviation 1.7	1.6 units on a scale Standard Deviation 1.3	1.9 units on a scale Standard Deviation 1.3	—
MADRS Concentration Difficulties Scores From Baseline to Month 36 Endpoint; n=27, 22, 17	1.6 units on a scale Standard Deviation 1.7	1.6 units on a scale Standard Deviation 1.5	1.7 units on a scale Standard Deviation 1.3	—

SECONDARY outcome

Timeframe: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)

MADRS is a depression rating scale consisting of 10 items representing the core symptoms of depressive illness, each rated 0 (no symptom) to 6 (severe symptom). Lassitude scores rate difficulty in getting started or slowness in initiating and performing everyday activities.

Outcome measures

Outcome measures
Measure	Duodopa Non-naïve ≥ 2 Years n=18 Participants Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Duodopa Naïve n=27 Participants Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Duodopa Non-naïve < 2 Years n=22 Participants Duodopa non-naïve participants treated with Duodopa for \< 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Total All participants
MADRS Lassitude Scores From Baseline to Month 36 Month 9; n=25, 20, 17	1.7 units on a scale Standard Deviation 1.2	1.3 units on a scale Standard Deviation 1.2	1.5 units on a scale Standard Deviation 1.2	—
MADRS Lassitude Scores From Baseline to Month 36 Baseline (Month -3); n=26, 0, 0	NA units on a scale Standard Deviation NA Baseline for Duodopa non-naive participants was not done.	1.3 units on a scale Standard Deviation 1.4	NA units on a scale Standard Deviation NA Baseline for Duodopa non-naive participants was not done.	—
MADRS Lassitude Scores From Baseline to Month 36 Month 0; n=27, 22, 18	1.7 units on a scale Standard Deviation 1.5	1.4 units on a scale Standard Deviation 1.3	1.4 units on a scale Standard Deviation 1.2	—
MADRS Lassitude Scores From Baseline to Month 36 Month 3; n=24, 22, 17	2.0 units on a scale Standard Deviation 1.6	1.7 units on a scale Standard Deviation 1.3	1.5 units on a scale Standard Deviation 1.0	—
MADRS Lassitude Scores From Baseline to Month 36 Month 6; n=25, 21, 17	1.3 units on a scale Standard Deviation 1.5	1.5 units on a scale Standard Deviation 1.3	1.5 units on a scale Standard Deviation 1.2	—
MADRS Lassitude Scores From Baseline to Month 36 Month 12; n=25, 20, 17	1.4 units on a scale Standard Deviation 1.6	1.6 units on a scale Standard Deviation 1.4	1.6 units on a scale Standard Deviation 1.3	—
MADRS Lassitude Scores From Baseline to Month 36 Month 18; n=24, 19, 16	1.6 units on a scale Standard Deviation 1.1	1.8 units on a scale Standard Deviation 1.6	1.4 units on a scale Standard Deviation 1.2	—
MADRS Lassitude Scores From Baseline to Month 36 Month 24; n=23, 18, 15	1.7 units on a scale Standard Deviation 1.4	1.7 units on a scale Standard Deviation 1.5	1.9 units on a scale Standard Deviation 1.1	—
MADRS Lassitude Scores From Baseline to Month 36 Month 30; n=23, 17, 13	1.3 units on a scale Standard Deviation 1.1	2.0 units on a scale Standard Deviation 1.4	1.7 units on a scale Standard Deviation 1.3	—
MADRS Lassitude Scores From Baseline to Month 36 Month 36; n=21, 16, 12	1.7 units on a scale Standard Deviation 1.4	1.9 units on a scale Standard Deviation 1.5	1.8 units on a scale Standard Deviation 1.4	—
MADRS Lassitude Scores From Baseline to Month 36 Endpoint; n=27, 22, 17	1.7 units on a scale Standard Deviation 1.4	1.8 units on a scale Standard Deviation 1.5	1.7 units on a scale Standard Deviation 1.4	—

SECONDARY outcome

Timeframe: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)

MADRS is a depression rating scale consisting of 10 items representing the core symptoms of depressive illness, each rated 0 (no symptom) to 6 (severe symptom). Inability to Feel scores rate the subjective experience of reduced interest in the surroundings, or activities that normally give pleasure. The ability to react with adequate emotion to circumstances or people is reduced.

Outcome measures

Outcome measures
Measure	Duodopa Non-naïve ≥ 2 Years n=18 Participants Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Duodopa Naïve n=27 Participants Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Duodopa Non-naïve < 2 Years n=22 Participants Duodopa non-naïve participants treated with Duodopa for \< 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Total All participants
MADRS Inability to Feel Scores From Baseline to Month 36 Baseline (Month -3); n=26, 0, 0	NA units on a scale Standard Deviation NA Baseline for Duodopa non-naive participants was not done.	0.5 units on a scale Standard Deviation 0.6	NA units on a scale Standard Deviation NA Baseline for Duodopa non-naive participants was not done.	—
MADRS Inability to Feel Scores From Baseline to Month 36 Month 0; n=27, 22, 18	0.8 units on a scale Standard Deviation 0.8	0.4 units on a scale Standard Deviation 0.7	0.2 units on a scale Standard Deviation 0.5	—
MADRS Inability to Feel Scores From Baseline to Month 36 Month 3; n=24, 22, 17	0.6 units on a scale Standard Deviation 1.1	0.6 units on a scale Standard Deviation 0.9	0.6 units on a scale Standard Deviation 0.9	—
MADRS Inability to Feel Scores From Baseline to Month 36 Month 6; n=25, 21, 17	0.8 units on a scale Standard Deviation 1.3	0.6 units on a scale Standard Deviation 1.0	0.4 units on a scale Standard Deviation 0.7	—
MADRS Inability to Feel Scores From Baseline to Month 36 Month 9; n=25, 20, 17	0.7 units on a scale Standard Deviation 1.1	0.5 units on a scale Standard Deviation 0.8	0.6 units on a scale Standard Deviation 0.6	—
MADRS Inability to Feel Scores From Baseline to Month 36 Month 12; n=25, 20, 17	0.5 units on a scale Standard Deviation 1.1	0.6 units on a scale Standard Deviation 0.8	0.4 units on a scale Standard Deviation 0.6	—
MADRS Inability to Feel Scores From Baseline to Month 36 Month 18; n=24, 19, 16	0.8 units on a scale Standard Deviation 1.0	0.5 units on a scale Standard Deviation 0.8	0.5 units on a scale Standard Deviation 0.6	—
MADRS Inability to Feel Scores From Baseline to Month 36 Month 24; n=23, 18, 15	1.1 units on a scale Standard Deviation 1.4	0.5 units on a scale Standard Deviation 0.7	0.6 units on a scale Standard Deviation 0.7	—
MADRS Inability to Feel Scores From Baseline to Month 36 Month 30; n=23, 17, 13	0.7 units on a scale Standard Deviation 0.9	0.4 units on a scale Standard Deviation 0.6	0.7 units on a scale Standard Deviation 0.7	—
MADRS Inability to Feel Scores From Baseline to Month 36 Month 36; n=21, 16, 12	0.7 units on a scale Standard Deviation 1.4	0.6 units on a scale Standard Deviation 0.8	0.5 units on a scale Standard Deviation 0.7	—
MADRS Inability to Feel Scores From Baseline to Month 36 Endpoint; n=27, 22, 17	0.9 units on a scale Standard Deviation 1.4	0.6 units on a scale Standard Deviation 0.8	0.6 units on a scale Standard Deviation 0.7	—

SECONDARY outcome

Timeframe: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)

MADRS is a depression rating scale consisting of 10 items representing the core symptoms of depressive illness, each rated 0 (no symptom) to 6 (severe symptom). Pessimistic Thoughts scores rate thoughts of guilt, inferiority, self-reproach, sinfulness, remorse and ruin.

Outcome measures

Outcome measures
Measure	Duodopa Non-naïve ≥ 2 Years n=18 Participants Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Duodopa Naïve n=27 Participants Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Duodopa Non-naïve < 2 Years n=22 Participants Duodopa non-naïve participants treated with Duodopa for \< 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Total All participants
MADRS Pessimistic Thoughts Scores From Baseline to Month 36 Month 0; n=27, 22, 18	0.6 units on a scale Standard Deviation 0.8	1.0 units on a scale Standard Deviation 0.8	0.5 units on a scale Standard Deviation 0.9	—
MADRS Pessimistic Thoughts Scores From Baseline to Month 36 Month 9; n=25, 20, 17	0.9 units on a scale Standard Deviation 1.0	0.8 units on a scale Standard Deviation 0.8	0.5 units on a scale Standard Deviation 0.5	—
MADRS Pessimistic Thoughts Scores From Baseline to Month 36 Month 12; n=25, 20, 17	1.0 units on a scale Standard Deviation 0.9	0.9 units on a scale Standard Deviation 0.8	0.8 units on a scale Standard Deviation 0.8	—
MADRS Pessimistic Thoughts Scores From Baseline to Month 36 Month 18; n=24, 19, 16	0.8 units on a scale Standard Deviation 0.8	1.0 units on a scale Standard Deviation 0.8	0.7 units on a scale Standard Deviation 0.9	—
MADRS Pessimistic Thoughts Scores From Baseline to Month 36 Baseline (Month -3); n=26, 0, 0	NA units on a scale Standard Deviation NA Baseline for Duodopa non-naive participants was not done.	0.9 units on a scale Standard Deviation 1.1	NA units on a scale Standard Deviation NA Baseline for Duodopa non-naive participants was not done.	—
MADRS Pessimistic Thoughts Scores From Baseline to Month 36 Month 3; n=24, 22, 17	0.8 units on a scale Standard Deviation 1.0	0.7 units on a scale Standard Deviation 0.9	0.5 units on a scale Standard Deviation 1.0	—
MADRS Pessimistic Thoughts Scores From Baseline to Month 36 Month 6; n=25, 21, 17	0.6 units on a scale Standard Deviation 0.9	0.9 units on a scale Standard Deviation 0.9	0.6 units on a scale Standard Deviation 0.7	—
MADRS Pessimistic Thoughts Scores From Baseline to Month 36 Month 24; n=23, 18, 15	1.1 units on a scale Standard Deviation 0.9	1.0 units on a scale Standard Deviation 1.0	0.7 units on a scale Standard Deviation 0.8	—
MADRS Pessimistic Thoughts Scores From Baseline to Month 36 Month 30; n=22, 17, 13	0.9 units on a scale Standard Deviation 0.8	1.2 units on a scale Standard Deviation 0.9	0.7 units on a scale Standard Deviation 0.7	—
MADRS Pessimistic Thoughts Scores From Baseline to Month 36 Month 36; n=21, 16, 12	1.0 units on a scale Standard Deviation 1.1	1.0 units on a scale Standard Deviation 1.0	0.9 units on a scale Standard Deviation 0.8	—
MADRS Pessimistic Thoughts Scores From Baseline to Month 36 Endpoint; n=26, 22, 17	1.1 units on a scale Standard Deviation 1.2	1.2 units on a scale Standard Deviation 1.1	0.9 units on a scale Standard Deviation 0.8	—

SECONDARY outcome

Timeframe: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)

MADRS is a depression rating scale consisting of 10 items representing the core symptoms of depressive illness, each rated 0 (no symptom) to 6 (severe symptom). Suicidal Thoughts scores rate the feeling that life is not worth living, that a natural death would be welcome, suicidal thoughts, and preparations for suicide.

Outcome measures

Outcome measures
Measure	Duodopa Non-naïve ≥ 2 Years n=18 Participants Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Duodopa Naïve n=27 Participants Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Duodopa Non-naïve < 2 Years n=22 Participants Duodopa non-naïve participants treated with Duodopa for \< 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Total All participants
MADRS Suicidal Thoughts Scores From Baseline to Month 36 Baseline (Month -3); n=26, 0, 0	NA units on a scale Standard Deviation NA Baseline for Duodopa non-naive participants was not done.	0.4 units on a scale Standard Deviation 0.6	NA units on a scale Standard Deviation NA Baseline for Duodopa non-naive participants was not done.	—
MADRS Suicidal Thoughts Scores From Baseline to Month 36 Month 0; n=27, 22, 18	0.3 units on a scale Standard Deviation 0.7	0.5 units on a scale Standard Deviation 1.0	0.2 units on a scale Standard Deviation 0.6	—
MADRS Suicidal Thoughts Scores From Baseline to Month 36 Month 3; n=24, 22, 17	0.4 units on a scale Standard Deviation 0.6	0.5 units on a scale Standard Deviation 1.1	0.0 units on a scale Standard Deviation 0.2	—
MADRS Suicidal Thoughts Scores From Baseline to Month 36 Month 6; n=25, 21, 17	0.2 units on a scale Standard Deviation 0.4	0.5 units on a scale Standard Deviation 1.0	0.1 units on a scale Standard Deviation 0.4	—
MADRS Suicidal Thoughts Scores From Baseline to Month 36 Month 9; n=25, 20, 17	0.2 units on a scale Standard Deviation 0.4	0.3 units on a scale Standard Deviation 0.7	0.0 units on a scale Standard Deviation 0.0	—
MADRS Suicidal Thoughts Scores From Baseline to Month 36 Month 12; n=25, 20, 17	0.2 units on a scale Standard Deviation 0.7	0.3 units on a scale Standard Deviation 0.7	0.3 units on a scale Standard Deviation 0.4	—
MADRS Suicidal Thoughts Scores From Baseline to Month 36 Month 18; n=24, 19, 16	0.2 units on a scale Standard Deviation 0.4	0.5 units on a scale Standard Deviation 0.9	0.3 units on a scale Standard Deviation 0.7	—
MADRS Suicidal Thoughts Scores From Baseline to Month 36 Month 24; n=23, 18, 15	0.4 units on a scale Standard Deviation 0.8	0.1 units on a scale Standard Deviation 0.3	0.2 units on a scale Standard Deviation 0.5	—
MADRS Suicidal Thoughts Scores From Baseline to Month 36 Month 30; n=23, 17, 13	0.2 units on a scale Standard Deviation 0.4	0.4 units on a scale Standard Deviation 0.8	0.1 units on a scale Standard Deviation 0.3	—
MADRS Suicidal Thoughts Scores From Baseline to Month 36 Month 36; n=21, 16, 12	0.1 units on a scale Standard Deviation 0.3	0.5 units on a scale Standard Deviation 1.0	0.1 units on a scale Standard Deviation 0.3	—
MADRS Suicidal Thoughts Scores From Baseline to Month 36 Endpoint; n=27, 22, 17	0.4 units on a scale Standard Deviation 0.8	0.4 units on a scale Standard Deviation 0.9	0.2 units on a scale Standard Deviation 0.4	—

SECONDARY outcome

Timeframe: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)

Outcome measures

Outcome measures
Measure	Duodopa Non-naïve ≥ 2 Years n=18 Participants Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Duodopa Naïve n=27 Participants Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Duodopa Non-naïve < 2 Years n=22 Participants Duodopa non-naïve participants treated with Duodopa for \< 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Total All participants
Parkinson's Disease Questionnaire-39 (PDQ-39) Summary Index Scores From Baseline to Month 36 Month 30; n=21, 16, 12	34.4 units on a scale Standard Deviation 17.4	33.5 units on a scale Standard Deviation 13.1	34.8 units on a scale Standard Deviation 16.2	—
Parkinson's Disease Questionnaire-39 (PDQ-39) Summary Index Scores From Baseline to Month 36 Baseline (Month -3); n=27, 0, 0	NA units on a scale Standard Deviation NA Baseline for Duodopa non-naive participants was not done.	33.6 units on a scale Standard Deviation 10.8	NA units on a scale Standard Deviation NA Baseline for Duodopa non-naive participants was not done.	—
Parkinson's Disease Questionnaire-39 (PDQ-39) Summary Index Scores From Baseline to Month 36 Month 0; n=27, 20, 17	36.6 units on a scale Standard Deviation 15.4	27.1 units on a scale Standard Deviation 11.8	30.3 units on a scale Standard Deviation 10.7	—
Parkinson's Disease Questionnaire-39 (PDQ-39) Summary Index Scores From Baseline to Month 36 Month 3; n=22, 20, 18	34.0 units on a scale Standard Deviation 15.2	24.5 units on a scale Standard Deviation 10.1	30.0 units on a scale Standard Deviation 15.6	—
Parkinson's Disease Questionnaire-39 (PDQ-39) Summary Index Scores From Baseline to Month 36 Month 6; n=24, 20, 17	35.5 units on a scale Standard Deviation 16.5	27.9 units on a scale Standard Deviation 10.6	33.4 units on a scale Standard Deviation 16.2	—
Parkinson's Disease Questionnaire-39 (PDQ-39) Summary Index Scores From Baseline to Month 36 Month 9; n=23, 20, 16	35.1 units on a scale Standard Deviation 15.9	25.9 units on a scale Standard Deviation 10.6	30.9 units on a scale Standard Deviation 12.1	—
Parkinson's Disease Questionnaire-39 (PDQ-39) Summary Index Scores From Baseline to Month 36 Month 12; n=23, 19, 17	38.3 units on a scale Standard Deviation 19.3	28.8 units on a scale Standard Deviation 12.8	33.2 units on a scale Standard Deviation 15.5	—
Parkinson's Disease Questionnaire-39 (PDQ-39) Summary Index Scores From Baseline to Month 36 Month 18; n=22, 18, 16	34.1 units on a scale Standard Deviation 17.0	28.2 units on a scale Standard Deviation 12.2	30.4 units on a scale Standard Deviation 15.7	—
Parkinson's Disease Questionnaire-39 (PDQ-39) Summary Index Scores From Baseline to Month 36 Month 24; n=21, 17, 14	33.6 units on a scale Standard Deviation 13.6	30.3 units on a scale Standard Deviation 12.4	36.2 units on a scale Standard Deviation 14.6	—
Parkinson's Disease Questionnaire-39 (PDQ-39) Summary Index Scores From Baseline to Month 36 Month 36; n=20, 15, 11	39.2 units on a scale Standard Deviation 18.0	36.8 units on a scale Standard Deviation 15.1	31.5 units on a scale Standard Deviation 11.5	—
Parkinson's Disease Questionnaire-39 (PDQ-39) Summary Index Scores From Baseline to Month 36 Endpoint; n=25, 21, 17	40.3 units on a scale Standard Deviation 17.5	36.2 units on a scale Standard Deviation 14.1	34.0 units on a scale Standard Deviation 13.6	—

SECONDARY outcome

Timeframe: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)

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 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

Outcome measures
Measure	Duodopa Non-naïve ≥ 2 Years n=18 Participants Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Duodopa Naïve n=27 Participants Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Duodopa Non-naïve < 2 Years n=22 Participants Duodopa non-naïve participants treated with Duodopa for \< 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Total All participants
PDQ-39 Mobility Subscale Scores From Baseline to Month 36 Baseline (Month -3); n=27, 0, 0	NA units on a scale Standard Deviation NA Baseline for Duodopa non-naive participants was not done.	55.7 units on a scale Standard Deviation 20.5	NA units on a scale Standard Deviation NA Baseline for Duodopa non-naive participants was not done.	—
PDQ-39 Mobility Subscale Scores From Baseline to Month 36 Month 18; n=24, 18, 16	54.7 units on a scale Standard Deviation 29.2	40.9 units on a scale Standard Deviation 16.2	41.1 units on a scale Standard Deviation 25.6	—
PDQ-39 Mobility Subscale Scores From Baseline to Month 36 Month 0; n=27, 22, 18	53.3 units on a scale Standard Deviation 22.6	38.8 units on a scale Standard Deviation 20.1	43.9 units on a scale Standard Deviation 21.7	—
PDQ-39 Mobility Subscale Scores From Baseline to Month 36 Month 3; n=23, 20, 18	50.6 units on a scale Standard Deviation 24.2	36.0 units on a scale Standard Deviation 17.6	40.6 units on a scale Standard Deviation 22.8	—
PDQ-39 Mobility Subscale Scores From Baseline to Month 36 Month 6; n=25, 21, 18	54.7 units on a scale Standard Deviation 24.4	39.5 units on a scale Standard Deviation 18.9	43.5 units on a scale Standard Deviation 23.5	—
PDQ-39 Mobility Subscale Scores From Baseline to Month 36 Month 9; n=24, 20, 17	52.8 units on a scale Standard Deviation 23.0	40.2 units on a scale Standard Deviation 15.6	41.9 units on a scale Standard Deviation 21.7	—
PDQ-39 Mobility Subscale Scores From Baseline to Month 36 Month 12; n=25, 20, 17	54.4 units on a scale Standard Deviation 32.1	41.0 units on a scale Standard Deviation 18.3	45.3 units on a scale Standard Deviation 24.2	—
PDQ-39 Mobility Subscale Scores From Baseline to Month 36 Month 24; n=21, 17, 15	49.5 units on a scale Standard Deviation 23.0	46.0 units on a scale Standard Deviation 22.2	47.1 units on a scale Standard Deviation 21.5	—
PDQ-39 Mobility Subscale Scores From Baseline to Month 36 Month 30; n=22, 17, 12	53.3 units on a scale Standard Deviation 24.8	50.9 units on a scale Standard Deviation 21.5	42.1 units on a scale Standard Deviation 21.5	—
PDQ-39 Mobility Subscale Scores From Baseline to Month 36 Month 36; n=21, 15, 11	61.1 units on a scale Standard Deviation 28.1	57.3 units on a scale Standard Deviation 20.8	43.0 units on a scale Standard Deviation 21.6	—
PDQ-39 Mobility Subscale Scores From Baseline to Month 36 Endpoint; n=26, 21, 17	61.6 units on a scale Standard Deviation 25.0	55.6 units on a scale Standard Deviation 20.7	50.2 units on a scale Standard Deviation 22.2	—

SECONDARY outcome

Timeframe: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)

Outcome measures

Outcome measures
Measure	Duodopa Non-naïve ≥ 2 Years n=18 Participants Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Duodopa Naïve n=27 Participants Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Duodopa Non-naïve < 2 Years n=22 Participants Duodopa non-naïve participants treated with Duodopa for \< 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Total All participants
PDQ-39 Activities of Daily Living Subscale Scores From Baseline to Month 36 Month 36; n=21, 15, 11	54.5 units on a scale Standard Deviation 29.3	45.4 units on a scale Standard Deviation 25.1	47.5 units on a scale Standard Deviation 18.4	—
PDQ-39 Activities of Daily Living Subscale Scores From Baseline to Month 36 Baseline (Month -3); n=27, 0, 0	NA units on a scale Standard Deviation NA Baseline for Duodopa non-naive participants was not done.	38.7 units on a scale Standard Deviation 21.5	NA units on a scale Standard Deviation NA Baseline for Duodopa non-naive participants was not done.	—
PDQ-39 Activities of Daily Living Subscale Scores From Baseline to Month 36 Month 0; n=27, 20, 18	46.5 units on a scale Standard Deviation 26.5	32.1 units on a scale Standard Deviation 19.0	40.8 units on a scale Standard Deviation 19.1	—
PDQ-39 Activities of Daily Living Subscale Scores From Baseline to Month 36 Month 3; n=24, 22, 18	41.7 units on a scale Standard Deviation 22.2	26.9 units on a scale Standard Deviation 16.6	42.8 units on a scale Standard Deviation 21.8	—
PDQ-39 Activities of Daily Living Subscale Scores From Baseline to Month 36 Month 6; n=25, 21, 18	42.1 units on a scale Standard Deviation 22.5	31.8 units on a scale Standard Deviation 18.9	43.7 units on a scale Standard Deviation 23.2	—
PDQ-39 Activities of Daily Living Subscale Scores From Baseline to Month 36 Month 9; n=25, 20, 17	42.2 units on a scale Standard Deviation 21.3	29.8 units on a scale Standard Deviation 19.2	37.5 units on a scale Standard Deviation 18.4	—
PDQ-39 Activities of Daily Living Subscale Scores From Baseline to Month 36 Month 12; n=25, 20, 17	45.6 units on a scale Standard Deviation 26.5	34.7 units on a scale Standard Deviation 20.8	42.1 units on a scale Standard Deviation 20.7	—
PDQ-39 Activities of Daily Living Subscale Scores From Baseline to Month 36 Month 18; n=24, 20, 16	45.8 units on a scale Standard Deviation 24.6	33.2 units on a scale Standard Deviation 20.1	41.9 units on a scale Standard Deviation 22.9	—
PDQ-39 Activities of Daily Living Subscale Scores From Baseline to Month 36 Month 24; n=21, 17, 15	41.9 units on a scale Standard Deviation 24.1	37.1 units on a scale Standard Deviation 22.1	48.3 units on a scale Standard Deviation 20.8	—
PDQ-39 Activities of Daily Living Subscale Scores From Baseline to Month 36 Month 30; n=22, 17, 12	46.5 units on a scale Standard Deviation 28.2	38.8 units on a scale Standard Deviation 23.8	48.5 units on a scale Standard Deviation 19.7	—
PDQ-39 Activities of Daily Living Subscale Scores From Baseline to Month 36 Endpoint; n=26, 22, 17	53.4 units on a scale Standard Deviation 24.5	43.4 units on a scale Standard Deviation 23.3	48.3 units on a scale Standard Deviation 18.2	—

SECONDARY outcome

Timeframe: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)

Outcome measures

Outcome measures
Measure	Duodopa Non-naïve ≥ 2 Years n=18 Participants Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Duodopa Naïve n=27 Participants Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Duodopa Non-naïve < 2 Years n=22 Participants Duodopa non-naïve participants treated with Duodopa for \< 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Total All participants
PDQ-39 Emotional Well Being Subscale Scores From Baseline to Month 36 Month 3; n=23, 22, 18	35.4 units on a scale Standard Deviation 21.5	24.8 units on a scale Standard Deviation 19.5	27.5 units on a scale Standard Deviation 19.6	—
PDQ-39 Emotional Well Being Subscale Scores From Baseline to Month 36 Baseline (Month -3); n=27, 0, 0	NA units on a scale Standard Deviation NA Baseline for Duodopa non-naive participants was not done.	35.3 units on a scale Standard Deviation 19.3	NA units on a scale Standard Deviation NA Baseline for Duodopa non-naive participants was not done.	—
PDQ-39 Emotional Well Being Subscale Scores From Baseline to Month 36 Month 0; n=27, 22, 18	37.7 units on a scale Standard Deviation 17.0	30.9 units on a scale Standard Deviation 17.3	27.1 units on a scale Standard Deviation 19.3	—
PDQ-39 Emotional Well Being Subscale Scores From Baseline to Month 36 Month 6; n=25, 20, 18	35.9 units on a scale Standard Deviation 20.0	31.3 units on a scale Standard Deviation 15.2	33.3 units on a scale Standard Deviation 18.6	—
PDQ-39 Emotional Well Being Subscale Scores From Baseline to Month 36 Month 9; n=25, 20, 17	34.8 units on a scale Standard Deviation 18.6	33.0 units on a scale Standard Deviation 18.0	32.1 units on a scale Standard Deviation 17.0	—
PDQ-39 Emotional Well Being Subscale Scores From Baseline to Month 36 Month 12; n=25, 20, 17	38.0 units on a scale Standard Deviation 23.6	29.0 units on a scale Standard Deviation 17.8	34.8 units on a scale Standard Deviation 20.8	—
PDQ-39 Emotional Well Being Subscale Scores From Baseline to Month 36 Month 18; n=24, 20, 16	32.6 units on a scale Standard Deviation 22.5	32.1 units on a scale Standard Deviation 16.2	30.2 units on a scale Standard Deviation 19.5	—
PDQ-39 Emotional Well Being Subscale Scores From Baseline to Month 36 Month 24; n=21, 17, 15	33.1 units on a scale Standard Deviation 16.6	31.9 units on a scale Standard Deviation 17.3	37.7 units on a scale Standard Deviation 19.0	—
PDQ-39 Emotional Well Being Subscale Scores From Baseline to Month 36 Month 30; n=22, 16, 12	31.3 units on a scale Standard Deviation 18.2	33.9 units on a scale Standard Deviation 16.8	33.3 units on a scale Standard Deviation 25.2	—
PDQ-39 Emotional Well Being Subscale Scores From Baseline to Month 36 Month 36; n=21, 15, 11	38.6 units on a scale Standard Deviation 19.4	39.7 units on a scale Standard Deviation 18.5	30.0 units on a scale Standard Deviation 21.0	—
PDQ-39 Emotional Well Being Subscale Scores From Baseline to Month 36 Endpoint; n=26, 22, 17	39.7 units on a scale Standard Deviation 21.5	39.4 units on a scale Standard Deviation 17.8	31.1 units on a scale Standard Deviation 24.4	—

SECONDARY outcome

Timeframe: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)

Outcome measures

Outcome measures
Measure	Duodopa Non-naïve ≥ 2 Years n=18 Participants Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Duodopa Naïve n=27 Participants Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Duodopa Non-naïve < 2 Years n=22 Participants Duodopa non-naïve participants treated with Duodopa for \< 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Total All participants
PDQ-39 Stigma Subscale Scores From Baseline to Month 36 Month 0; n=27, 22, 18	22.9 units on a scale Standard Deviation 23.0	16.2 units on a scale Standard Deviation 16.8	16.5 units on a scale Standard Deviation 18.5	—
PDQ-39 Stigma Subscale Scores From Baseline to Month 36 Month 12; n=25, 19, 17	25.4 units on a scale Standard Deviation 25.5	17.8 units on a scale Standard Deviation 17.0	19.4 units on a scale Standard Deviation 19.9	—
PDQ-39 Stigma Subscale Scores From Baseline to Month 36 Baseline (Month -3); n=27, 0, 0	NA units on a scale Standard Deviation NA Baseline for Duodopa non-naive participants was not done.	24.8 units on a scale Standard Deviation 15.4	NA units on a scale Standard Deviation NA Baseline for Duodopa non-naive participants was not done.	—
PDQ-39 Stigma Subscale Scores From Baseline to Month 36 Month 3; n=24, 22, 18	19.8 units on a scale Standard Deviation 17.4	16.1 units on a scale Standard Deviation 15.0	18.8 units on a scale Standard Deviation 23.8	—
PDQ-39 Stigma Subscale Scores From Baseline to Month 36 Month 6; n=25, 21, 18	23.6 units on a scale Standard Deviation 24.4	20.8 units on a scale Standard Deviation 16.2	19.0 units on a scale Standard Deviation 19.3	—
PDQ-39 Stigma Subscale Scores From Baseline to Month 36 Month 9; n=25, 20, 17	24.6 units on a scale Standard Deviation 23.6	15.5 units on a scale Standard Deviation 15.7	12.8 units on a scale Standard Deviation 15.1	—
PDQ-39 Stigma Subscale Scores From Baseline to Month 36 Month 18; n=24, 20, 16	18.8 units on a scale Standard Deviation 22.0	15.6 units on a scale Standard Deviation 17.5	13.8 units on a scale Standard Deviation 15.1	—
PDQ-39 Stigma Subscale Scores From Baseline to Month 36 Month 24; n=21, 17, 15	15.4 units on a scale Standard Deviation 14.5	15.8 units on a scale Standard Deviation 12.4	23.5 units on a scale Standard Deviation 19.2	—
PDQ-39 Stigma Subscale Scores From Baseline to Month 36 Month 30; n=21, 17, 12	18.2 units on a scale Standard Deviation 21.4	16.4 units on a scale Standard Deviation 18.6	14.0 units on a scale Standard Deviation 23.6	—
PDQ-39 Stigma Subscale Scores From Baseline to Month 36 Month 36; n=21, 15, 11	24.4 units on a scale Standard Deviation 19.3	20.5 units on a scale Standard Deviation 19.1	12.9 units on a scale Standard Deviation 20.0	—
PDQ-39 Stigma Subscale Scores From Baseline to Month 36 Endpoint; n=26, 22, 17	25.0 units on a scale Standard Deviation 23.8	19.5 units on a scale Standard Deviation 18.8	15.6 units on a scale Standard Deviation 20.3	—

SECONDARY outcome

Timeframe: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)

Outcome measures

Outcome measures
Measure	Duodopa Non-naïve ≥ 2 Years n=18 Participants Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Duodopa Naïve n=27 Participants Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Duodopa Non-naïve < 2 Years n=22 Participants Duodopa non-naïve participants treated with Duodopa for \< 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Total All participants
PDQ-39 Social Support Subscale Scores From Baseline to Month 36 Baseline (Month -3); n=27,0,0	NA units on a scale Standard Deviation NA Baseline for Duodopa non-naive participants was not done.	8.3 units on a scale Standard Deviation 15.9	NA units on a scale Standard Deviation NA Baseline for Duodopa non-naive participants was not done.	—
PDQ-39 Social Support Subscale Scores From Baseline to Month 36 Month 0; n=27, 22, 17	22.1 units on a scale Standard Deviation 19.1	10.3 units on a scale Standard Deviation 18.2	12.9 units on a scale Standard Deviation 14.5	—
PDQ-39 Social Support Subscale Scores From Baseline to Month 36 Month 3; n=24, 22, 18	16.7 units on a scale Standard Deviation 19.6	10.8 units on a scale Standard Deviation 15.2	12.5 units on a scale Standard Deviation 18.7	—
PDQ-39 Social Support Subscale Scores From Baseline to Month 36 Month 6; n=25, 21, 17	24.3 units on a scale Standard Deviation 21.5	12.7 units on a scale Standard Deviation 18.0	13.1 units on a scale Standard Deviation 14.1	—
PDQ-39 Social Support Subscale Scores From Baseline to Month 36 Month 9; n=24, 20, 16	25.5 units on a scale Standard Deviation 18.1	10.2 units on a scale Standard Deviation 16.3	13.8 units on a scale Standard Deviation 14.9	—
PDQ-39 Social Support Subscale Scores From Baseline to Month 36 Month 12; n=23, 20, 17	28.4 units on a scale Standard Deviation 22.6	12.1 units on a scale Standard Deviation 19.5	19.6 units on a scale Standard Deviation 19.4	—
PDQ-39 Social Support Subscale Scores From Baseline to Month 36 Month 18; n=22, 20, 16	18.8 units on a scale Standard Deviation 18.4	12.7 units on a scale Standard Deviation 15.6	17.9 units on a scale Standard Deviation 19.4	—
PDQ-39 Social Support Subscale Scores From Baseline to Month 36 Month 24; n=21, 17, 14	21.7 units on a scale Standard Deviation 15.7	15.7 units on a scale Standard Deviation 18.5	20.6 units on a scale Standard Deviation 18.7	—
PDQ-39 Social Support Subscale Scores From Baseline to Month 36 Month 30; n=22, 17, 12	18.8 units on a scale Standard Deviation 22.8	18.2 units on a scale Standard Deviation 24.8	16.2 units on a scale Standard Deviation 20.3	—
PDQ-39 Social Support Subscale Scores From Baseline to Month 36 Month 36; n=21, 15, 11	29.5 units on a scale Standard Deviation 26.7	18.3 units on a scale Standard Deviation 21.0	11.7 units on a scale Standard Deviation 13.3	—
PDQ-39 Social Support Subscale Scores From Baseline to Month 36 Endpoint; n=26, 22, 17	27.9 units on a scale Standard Deviation 25.3	21.8 units on a scale Standard Deviation 25.3	14.4 units on a scale Standard Deviation 18.9	—

SECONDARY outcome

Timeframe: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)

Outcome measures

Outcome measures
Measure	Duodopa Non-naïve ≥ 2 Years n=18 Participants Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Duodopa Naïve n=27 Participants Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Duodopa Non-naïve < 2 Years n=22 Participants Duodopa non-naïve participants treated with Duodopa for \< 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Total All participants
PDQ-39 Cognition Subscale Scores From Baseline to Month 36 Month 18; n=24, 20, 16	30.1 units on a scale Standard Deviation 23.4	28.6 units on a scale Standard Deviation 20.2	31.3 units on a scale Standard Deviation 22.1	—
PDQ-39 Cognition Subscale Scores From Baseline to Month 36 Baseline (Month -3); n=27, 0, 0	NA units on a scale Standard Deviation NA Baseline for Duodopa non-naive participants was not done.	30.6 units on a scale Standard Deviation 15.6	NA units on a scale Standard Deviation NA Baseline for Duodopa non-naive participants was not done.	—
PDQ-39 Cognition Subscale Scores From Baseline to Month 36 Month 0; n=27, 22, 18	33.7 units on a scale Standard Deviation 16.9	22.5 units on a scale Standard Deviation 13.7	33.0 units on a scale Standard Deviation 16.6	—
PDQ-39 Cognition Subscale Scores From Baseline to Month 36 Month 3; n=24, 22, 18	32.3 units on a scale Standard Deviation 20.4	24.2 units on a scale Standard Deviation 17.7	36.6 units on a scale Standard Deviation 18.5	—
PDQ-39 Cognition Subscale Scores From Baseline to Month 36 Month 6; n=24, 21, 18	30.6 units on a scale Standard Deviation 16.9	25.5 units on a scale Standard Deviation 13.7	37.8 units on a scale Standard Deviation 18.3	—
PDQ-39 Cognition Subscale Scores From Baseline to Month 36 Month 9; n=25, 20, 17	31.6 units on a scale Standard Deviation 19.2	21.5 units on a scale Standard Deviation 14.9	35.6 units on a scale Standard Deviation 20.0	—
PDQ-39 Cognition Subscale Scores From Baseline to Month 36 Month 12; n=25, 20, 17	33.8 units on a scale Standard Deviation 23.2	26.8 units on a scale Standard Deviation 20.8	33.1 units on a scale Standard Deviation 19.7	—
PDQ-39 Cognition Subscale Scores From Baseline to Month 36 Month 24; n=21, 17, 15	27.5 units on a scale Standard Deviation 19.0	24.7 units on a scale Standard Deviation 14.7	41.9 units on a scale Standard Deviation 16.8	—
PDQ-39 Cognition Subscale Scores From Baseline to Month 36 Month 30; n=22, 16, 12	30.7 units on a scale Standard Deviation 24.6	31.5 units on a scale Standard Deviation 18.6	45.7 units on a scale Standard Deviation 23.7	—
PDQ-39 Cognition Subscale Scores From Baseline to Month 36 Month 36; n=20, 15, 11	30.7 units on a scale Standard Deviation 19.7	34.1 units on a scale Standard Deviation 19.4	42.1 units on a scale Standard Deviation 16.6	—
PDQ-39 Cognition Subscale Scores From Baseline to Month 36 Endpoint; n=25, 22, 17	34.9 units on a scale Standard Deviation 19.5	31.5 units on a scale Standard Deviation 19.8	39.2 units on a scale Standard Deviation 20.2	—

SECONDARY outcome

Timeframe: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)

Outcome measures

Outcome measures
Measure	Duodopa Non-naïve ≥ 2 Years n=18 Participants Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Duodopa Naïve n=27 Participants Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Duodopa Non-naïve < 2 Years n=22 Participants Duodopa non-naïve participants treated with Duodopa for \< 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Total All participants
PDQ-39 Communication Subscale Scores From Baseline to Month 36 Baseline (Month -3); n=27, 0, 0	NA units on a scale Standard Deviation NA Baseline for Duodopa non-naive participants was not done.	32.4 units on a scale Standard Deviation 21.6	NA units on a scale Standard Deviation NA Baseline for Duodopa non-naive participants was not done.	—
PDQ-39 Communication Subscale Scores From Baseline to Month 36 Month 0; n=27, 22, 18	35.2 units on a scale Standard Deviation 18.4	24.1 units on a scale Standard Deviation 18.7	27.3 units on a scale Standard Deviation 14.6	—
PDQ-39 Communication Subscale Scores From Baseline to Month 36 Month 3; n=24, 22, 18	31.9 units on a scale Standard Deviation 19.9	24.7 units on a scale Standard Deviation 20.3	32.2 units on a scale Standard Deviation 22.2	—
PDQ-39 Communication Subscale Scores From Baseline to Month 36 Month 6; n=24, 21, 18	33.8 units on a scale Standard Deviation 19.3	24.0 units on a scale Standard Deviation 17.1	32.5 units on a scale Standard Deviation 22.0	—
PDQ-39 Communication Subscale Scores From Baseline to Month 36 Month 9; n=25, 20, 17	28.9 units on a scale Standard Deviation 21.3	25.3 units on a scale Standard Deviation 23.3	31.7 units on a scale Standard Deviation 17.2	—
PDQ-39 Communication Subscale Scores From Baseline to Month 36 Month 12; n=25, 20, 17	33.8 units on a scale Standard Deviation 16.0	29.7 units on a scale Standard Deviation 20.1	34.2 units on a scale Standard Deviation 18.3	—
PDQ-39 Communication Subscale Scores From Baseline to Month 36 Month 18; n=24, 20, 16	29.7 units on a scale Standard Deviation 20.4	31.6 units on a scale Standard Deviation 21.8	32.1 units on a scale Standard Deviation 19.0	—
PDQ-39 Communication Subscale Scores From Baseline to Month 36 Month 24; n=21, 17, 15	30.6 units on a scale Standard Deviation 19.1	28.2 units on a scale Standard Deviation 19.6	34.8 units on a scale Standard Deviation 18.2	—
PDQ-39 Communication Subscale Scores From Baseline to Month 36 Month 30; n=22, 17, 12	41.7 units on a scale Standard Deviation 26.6	33.7 units on a scale Standard Deviation 22.6	37.7 units on a scale Standard Deviation 18.4	—
PDQ-39 Communication Subscale Scores From Baseline to Month 36 Month 36; n=21, 15, 11	37.9 units on a scale Standard Deviation 19.1	33.7 units on a scale Standard Deviation 20.7	33.3 units on a scale Standard Deviation 13.0	—
PDQ-39 Communication Subscale Scores From Baseline to Month 36 Endpoint; n=26, 22, 17	40.2 units on a scale Standard Deviation 18.7	34.0 units on a scale Standard Deviation 20.9	33.0 units on a scale Standard Deviation 15.5	—

SECONDARY outcome

Timeframe: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)

Outcome measures

Outcome measures
Measure	Duodopa Non-naïve ≥ 2 Years n=18 Participants Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Duodopa Naïve n=27 Participants Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Duodopa Non-naïve < 2 Years n=22 Participants Duodopa non-naïve participants treated with Duodopa for \< 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Total All participants
PDQ-39 Bodily Discomfort Subscale Scores From Baseline to Month 36 Baseline (Month -3); n=27, 0, 0	NA units on a scale Standard Deviation NA Baseline for Duodopa non-naive participants was not done.	42.6 units on a scale Standard Deviation 19.8	NA units on a scale Standard Deviation NA Baseline for Duodopa non-naive participants was not done.	—
PDQ-39 Bodily Discomfort Subscale Scores From Baseline to Month 36 Month 0; n=27, 22, 18	43.1 units on a scale Standard Deviation 24.8	41.7 units on a scale Standard Deviation 18.3	40.2 units on a scale Standard Deviation 17.6	—
PDQ-39 Bodily Discomfort Subscale Scores From Baseline to Month 36 Month 3; n=24, 22, 18	44.0 units on a scale Standard Deviation 21.4	38.5 units on a scale Standard Deviation 21.7	39.8 units on a scale Standard Deviation 20.7	—
PDQ-39 Bodily Discomfort Subscale Scores From Baseline to Month 36 Month 6; n=24, 21, 18	39.4 units on a scale Standard Deviation 23.2	38.9 units on a scale Standard Deviation 22.1	42.1 units on a scale Standard Deviation 20.5	—
PDQ-39 Bodily Discomfort Subscale Scores From Baseline to Month 36 Month 9; n=25, 20, 17	41.2 units on a scale Standard Deviation 24.7	36.3 units on a scale Standard Deviation 18.8	42.1 units on a scale Standard Deviation 23.6	—
PDQ-39 Bodily Discomfort Subscale Scores From Baseline to Month 36 Month 12; n=25, 20, 17	46.6 units on a scale Standard Deviation 27.6	39.3 units on a scale Standard Deviation 21.0	34.6 units on a scale Standard Deviation 20.1	—
PDQ-39 Bodily Discomfort Subscale Scores From Baseline to Month 36 Month 18; n=24, 20, 16	42.7 units on a scale Standard Deviation 24.5	38.5 units on a scale Standard Deviation 23.5	37.1 units on a scale Standard Deviation 20.7	—
PDQ-39 Bodily Discomfort Subscale Scores From Baseline to Month 36 Month 24; n=21, 17, 15	38.9 units on a scale Standard Deviation 23.7	42.9 units on a scale Standard Deviation 24.2	35.3 units on a scale Standard Deviation 25.8	—
PDQ-39 Bodily Discomfort Subscale Scores From Baseline to Month 36 Month 30; n=22, 17, 12	34.7 units on a scale Standard Deviation 27.3	42.8 units on a scale Standard Deviation 23.3	39.2 units on a scale Standard Deviation 24.8	—
PDQ-39 Bodily Discomfort Subscale Scores From Baseline to Month 36 Month 36; n=21, 15, 11	37.1 units on a scale Standard Deviation 20.2	42.9 units on a scale Standard Deviation 17.9	31.7 units on a scale Standard Deviation 15.8	—
PDQ-39 Bodily Discomfort Subscale Scores From Baseline to Month 36 Endpoint; n=26, 22, 17	39.7 units on a scale Standard Deviation 24.6	42.6 units on a scale Standard Deviation 19.2	36.7 units on a scale Standard Deviation 20.5	—

SECONDARY outcome

Timeframe: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)

Outcome measures

Outcome measures
Measure	Duodopa Non-naïve ≥ 2 Years n=18 Participants Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Duodopa Naïve n=27 Participants Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Duodopa Non-naïve < 2 Years n=22 Participants Duodopa non-naïve participants treated with Duodopa for \< 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Total All participants
Electronic Diary: Morning and Day Scores (Walking) From Baseline to Month 36 Day, Month 12; n=16, 16, 9	3.1 units on a scale Standard Deviation 1.2	3.7 units on a scale Standard Deviation 1.0	3.8 units on a scale Standard Deviation 1.1	—
Electronic Diary: Morning and Day Scores (Walking) From Baseline to Month 36 Morning, Month 18; n=15, 14, 10	3.4 units on a scale Standard Deviation 1.1	3.3 units on a scale Standard Deviation 1.2	3.5 units on a scale Standard Deviation 1.0	—
Electronic Diary: Morning and Day Scores (Walking) From Baseline to Month 36 Morning, Baseline (Month -3); n=20, 0, 0	NA units on a scale Standard Deviation NA Baseline for Duodopa non-naive participants was not done.	2.7 units on a scale Standard Deviation 1.2	NA units on a scale Standard Deviation NA Baseline for Duodopa non-naive participants was not done.	—
Electronic Diary: Morning and Day Scores (Walking) From Baseline to Month 36 Day, Baseline (Month -3); n=20, 0, 0	NA units on a scale Standard Deviation NA Baseline for Duodopa non-naive participants was not done.	3.1 units on a scale Standard Deviation 0.9	NA units on a scale Standard Deviation NA Baseline for Duodopa non-naive participants was not done.	—
Electronic Diary: Morning and Day Scores (Walking) From Baseline to Month 36 Morning, Month 0; n=19, 20, 15	3.4 units on a scale Standard Deviation 1.0	3.3 units on a scale Standard Deviation 1.4	3.2 units on a scale Standard Deviation 1.1	—
Electronic Diary: Morning and Day Scores (Walking) From Baseline to Month 36 Day, Month 0; n=19, 20, 15	3.3 units on a scale Standard Deviation 1.0	3.7 units on a scale Standard Deviation 1.1	3.7 units on a scale Standard Deviation 0.8	—
Electronic Diary: Morning and Day Scores (Walking) From Baseline to Month 36 Morning, Month 3; n=19, 19, 13	3.1 units on a scale Standard Deviation 1.0	3.5 units on a scale Standard Deviation 1.1	3.0 units on a scale Standard Deviation 1.1	—
Electronic Diary: Morning and Day Scores (Walking) From Baseline to Month 36 Day, Month 3; n=19, 19, 13	3.3 units on a scale Standard Deviation 0.9	3.7 units on a scale Standard Deviation 0.8	3.6 units on a scale Standard Deviation 1.0	—
Electronic Diary: Morning and Day Scores (Walking) From Baseline to Month 36 Morning, Month 6; n=16, 19, 11	3.3 units on a scale Standard Deviation 1.1	3.5 units on a scale Standard Deviation 1.2	3.2 units on a scale Standard Deviation 1.1	—
Electronic Diary: Morning and Day Scores (Walking) From Baseline to Month 36 Day, Month 6; n=16, 19, 11	3.4 units on a scale Standard Deviation 0.9	4.0 units on a scale Standard Deviation 0.7	3.7 units on a scale Standard Deviation 0.9	—
Electronic Diary: Morning and Day Scores (Walking) From Baseline to Month 36 Morning, Month 9; n=16, 17, 9	3.1 units on a scale Standard Deviation 1.3	3.6 units on a scale Standard Deviation 1.0	3.3 units on a scale Standard Deviation 1.0	—
Electronic Diary: Morning and Day Scores (Walking) From Baseline to Month 36 Day, Month 9; n=16, 17, 9	3.1 units on a scale Standard Deviation 1.2	4.0 units on a scale Standard Deviation 0.4	3.8 units on a scale Standard Deviation 0.9	—
Electronic Diary: Morning and Day Scores (Walking) From Baseline to Month 36 Morning, Month 12; n=16, 16, 9	3.1 units on a scale Standard Deviation 1.3	3.6 units on a scale Standard Deviation 1.2	3.5 units on a scale Standard Deviation 1.1	—
Electronic Diary: Morning and Day Scores (Walking) From Baseline to Month 36 Day, Month 18; n=15, 14, 10	3.5 units on a scale Standard Deviation 1.1	3.8 units on a scale Standard Deviation 0.8	3.9 units on a scale Standard Deviation 0.8	—
Electronic Diary: Morning and Day Scores (Walking) From Baseline to Month 36 Morning, Month 24; n=14, 13, 7	2.9 units on a scale Standard Deviation 1.3	3.4 units on a scale Standard Deviation 1.1	3.5 units on a scale Standard Deviation 1.0	—
Electronic Diary: Morning and Day Scores (Walking) From Baseline to Month 36 Day, Month 24; n=13, 13, 7	2.8 units on a scale Standard Deviation 1.5	3.9 units on a scale Standard Deviation 0.4	3.9 units on a scale Standard Deviation 0.9	—
Electronic Diary: Morning and Day Scores (Walking) From Baseline to Month 36 Morning, Month 30; n=9, 9, 5	3.6 units on a scale Standard Deviation 0.9	3.4 units on a scale Standard Deviation 1.3	3.4 units on a scale Standard Deviation 1.0	—
Electronic Diary: Morning and Day Scores (Walking) From Baseline to Month 36 Day, Month 30; n=9, 9, 5	3.9 units on a scale Standard Deviation 0.5	3.8 units on a scale Standard Deviation 0.7	4.0 units on a scale Standard Deviation 0.5	—
Electronic Diary: Morning and Day Scores (Walking) From Baseline to Month 36 Morning, Month 36; n=6, 11, 5	3.7 units on a scale Standard Deviation 0.9	2.3 units on a scale Standard Deviation 1.3	3.6 units on a scale Standard Deviation 1.0	—
Electronic Diary: Morning and Day Scores (Walking) From Baseline to Month 36 Day, Month 36; n=5, 11, 5	3.7 units on a scale Standard Deviation 0.6	3.1 units on a scale Standard Deviation 1.3	4.0 units on a scale Standard Deviation 1.0	—
Electronic Diary: Morning and Day Scores (Walking) From Baseline to Month 36 Morning, Endpoint; n=23, 20, 16	3.0 units on a scale Standard Deviation 1.0	2.8 units on a scale Standard Deviation 1.2	3.4 units on a scale Standard Deviation 1.0	—
Electronic Diary: Morning and Day Scores (Walking) From Baseline to Month 36 Day, Endpoint; n=23, 20, 16	3.0 units on a scale Standard Deviation 1.1	3.4 units on a scale Standard Deviation 1.0	3.8 units on a scale Standard Deviation 0.9	—

SECONDARY outcome

Timeframe: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)

Outcome measures

SECONDARY outcome

Timeframe: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)

Outcome measures

SECONDARY outcome

Timeframe: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)

Outcome measures

SECONDARY outcome

Timeframe: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)

Outcome measures

SECONDARY outcome

Timeframe: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)

Outcome measures

SECONDARY outcome

Timeframe: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)

Outcome measures

Outcome measures
Measure	Duodopa Non-naïve ≥ 2 Years n=18 Participants Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Duodopa Naïve n=27 Participants Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Duodopa Non-naïve < 2 Years n=22 Participants Duodopa non-naïve participants treated with Duodopa for \< 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Total All participants
Electronic Diary: Morning and Day Scores (Cramps) From Baseline to Month 36 Morning, Month 36; n=6, 11, 5	4.1 units on a scale Standard Deviation 1.3	4.5 units on a scale Standard Deviation 0.4	4.7 units on a scale Standard Deviation 0.3	—
Electronic Diary: Morning and Day Scores (Cramps) From Baseline to Month 36 Morning, Baseline (Month -3); n=20, 0, 0	NA units on a scale Standard Deviation NA Baseline for Duodopa non-naive participants was not done.	4.4 units on a scale Standard Deviation 0.7	NA units on a scale Standard Deviation NA Baseline for Duodopa non-naive participants was not done.	—
Electronic Diary: Morning and Day Scores (Cramps) From Baseline to Month 36 Day, Baseline (Month -3); n=20, 0, 0	NA units on a scale Standard Deviation NA Baseline for Duodopa non-naive participants was not done.	4.5 units on a scale Standard Deviation 0.6	NA units on a scale Standard Deviation NA Baseline for Duodopa non-naive participants was not done.	—
Electronic Diary: Morning and Day Scores (Cramps) From Baseline to Month 36 Morning, Month 0; n=19, 20, 15	4.6 units on a scale Standard Deviation 0.4	4.7 units on a scale Standard Deviation 0.4	4.6 units on a scale Standard Deviation 0.7	—
Electronic Diary: Morning and Day Scores (Cramps) From Baseline to Month 36 Day, Month 0; n=19, 20, 15	4.6 units on a scale Standard Deviation 0.5	4.7 units on a scale Standard Deviation 0.4	4.7 units on a scale Standard Deviation 0.5	—
Electronic Diary: Morning and Day Scores (Cramps) From Baseline to Month 36 Morning, Month 3; n=19, 18, 13	4.5 units on a scale Standard Deviation 0.6	4.8 units on a scale Standard Deviation 0.3	4.6 units on a scale Standard Deviation 0.7	—
Electronic Diary: Morning and Day Scores (Cramps) From Baseline to Month 36 Day, Month 3; n=19, 19, 13	4.5 units on a scale Standard Deviation 0.7	4.7 units on a scale Standard Deviation 0.5	4.7 units on a scale Standard Deviation 0.6	—
Electronic Diary: Morning and Day Scores (Cramps) From Baseline to Month 36 Morning, Month 6; n=16, 19, 11	4.3 units on a scale Standard Deviation 1.2	4.8 units on a scale Standard Deviation 0.3	4.5 units on a scale Standard Deviation 0.9	—
Electronic Diary: Morning and Day Scores (Cramps) From Baseline to Month 36 Day, Month 6; n=16, 19, 11	4.3 units on a scale Standard Deviation 1.1	4.8 units on a scale Standard Deviation 0.3	4.5 units on a scale Standard Deviation 0.8	—
Electronic Diary: Morning and Day Scores (Cramps) From Baseline to Month 36 Morning, Month 9; n=16, 17, 9	4.4 units on a scale Standard Deviation 1.0	4.8 units on a scale Standard Deviation 0.3	4.4 units on a scale Standard Deviation 0.7	—
Electronic Diary: Morning and Day Scores (Cramps) From Baseline to Month 36 Day, Month 9; n=16, 17, 9	4.3 units on a scale Standard Deviation 0.9	4.7 units on a scale Standard Deviation 0.5	4.5 units on a scale Standard Deviation 0.7	—
Electronic Diary: Morning and Day Scores (Cramps) From Baseline to Month 36 Morning, Month 12; n=16, 16, 9	4.2 units on a scale Standard Deviation 1.4	4.8 units on a scale Standard Deviation 0.3	4.5 units on a scale Standard Deviation 0.7	—
Electronic Diary: Morning and Day Scores (Cramps) From Baseline to Month 36 Day, Month 12; n=16, 16, 9	4.1 units on a scale Standard Deviation 1.3	4.5 units on a scale Standard Deviation 0.7	4.7 units on a scale Standard Deviation 0.5	—
Electronic Diary: Morning and Day Scores (Cramps) From Baseline to Month 36 Morning, Month 18; n=15, 14, 10	4.1 units on a scale Standard Deviation 0.8	4.7 units on a scale Standard Deviation 0.4	4.4 units on a scale Standard Deviation 0.8	—
Electronic Diary: Morning and Day Scores (Cramps) From Baseline to Month 36 Day, Month 18; n=15, 14, 10	4.3 units on a scale Standard Deviation 1.0	4.7 units on a scale Standard Deviation 0.5	4.6 units on a scale Standard Deviation 0.5	—
Electronic Diary: Morning and Day Scores (Cramps) From Baseline to Month 36 Morning, Month 24; n=13, 13, 7	4.0 units on a scale Standard Deviation 1.4	4.6 units on a scale Standard Deviation 0.4	4.8 units on a scale Standard Deviation 0.2	—
Electronic Diary: Morning and Day Scores (Cramps) From Baseline to Month 36 Day, Month 24; n=13, 13, 7	4.0 units on a scale Standard Deviation 1.3	4.5 units on a scale Standard Deviation 0.6	4.8 units on a scale Standard Deviation 0.3	—
Electronic Diary: Morning and Day Scores (Cramps) From Baseline to Month 36 Morning, Month 30; n=9, 9, 5	4.1 units on a scale Standard Deviation 1.5	4.9 units on a scale Standard Deviation 0.3	4.7 units on a scale Standard Deviation 0.4	—
Electronic Diary: Morning and Day Scores (Cramps) From Baseline to Month 36 Day, Month 30; n=9, 9, 5	3.9 units on a scale Standard Deviation 1.5	4.9 units on a scale Standard Deviation 0.3	4.8 units on a scale Standard Deviation 0.2	—
Electronic Diary: Morning and Day Scores (Cramps) From Baseline to Month 36 Day, Month 36; n=5, 11, 5	4.2 units on a scale Standard Deviation 1.0	4.7 units on a scale Standard Deviation 0.6	4.8 units on a scale Standard Deviation 0.2	—
Electronic Diary: Morning and Day Scores (Cramps) From Baseline to Month 36 Morning, Endpoint; n=23, 20, 16	4.4 units on a scale Standard Deviation 0.8	4.6 units on a scale Standard Deviation 0.4	4.5 units on a scale Standard Deviation 0.7	—
Electronic Diary: Morning and Day Scores (Cramps) From Baseline to Month 36 Day, Endpoint; n=23, 20, 16	4.5 units on a scale Standard Deviation 0.7	4.5 units on a scale Standard Deviation 0.6	4.6 units on a scale Standard Deviation 0.5	—

SECONDARY outcome

Timeframe: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)

Outcome measures

SECONDARY outcome

Timeframe: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)

The Electronic Diary consisted of 15 items addressing motor performance, complication of therapy, self-assessment, and various types of tapping. Six conceptual dimensions were defined; four subjectively-reported: 'walking', 'satisfied', 'dyskinesia', and 'off' and two objectively-measured: 'tapping' and 'spiral'. Each of the items was assessed in the morning and during the day. 'Self-assessment' scores were -3 (Off) to +3 (dyskinetic). 'Off' time is when PD symptoms are not adequately controlled by the drug. 'Dyskinetic' time is time with involuntary muscle movement. "0" is defined as the normal ON state without dyskinesia (the desired motor state). Everything closer to "0" means improvement, everything more away from "0" means either less mobility (in the negative score) or involuntary movements (dyskinesia, in the positive score).

Outcome measures

SECONDARY outcome

Timeframe: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)

Outcome measures

Outcome measures
Measure	Duodopa Non-naïve ≥ 2 Years n=18 Participants Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Duodopa Naïve n=27 Participants Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Duodopa Non-naïve < 2 Years n=22 Participants Duodopa non-naïve participants treated with Duodopa for \< 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Total All participants
Electronic Diary: Morning and Day Scores (Free Tapping - Speed) From Baseline to Month 36 Day, Month 9; n=16, 17, 9	47.0 taps/20 seconds Standard Deviation 15.3	48.1 taps/20 seconds Standard Deviation 15.7	48.0 taps/20 seconds Standard Deviation 16.8	—
Electronic Diary: Morning and Day Scores (Free Tapping - Speed) From Baseline to Month 36 Morning, Baseline (Month -3); n=20, 0, 0	NA taps/20 seconds Standard Deviation NA Baseline for Duodopa non-naive participants was not done.	39.9 taps/20 seconds Standard Deviation 12.8	NA taps/20 seconds Standard Deviation NA Baseline for Duodopa non-naive participants was not done.	—
Electronic Diary: Morning and Day Scores (Free Tapping - Speed) From Baseline to Month 36 Day, Baseline (Month -3); n=20, 0, 0	NA taps/20 seconds Standard Deviation NA Baseline for Duodopa non-naive participants was not done.	39.7 taps/20 seconds Standard Deviation 11.2	NA taps/20 seconds Standard Deviation NA Baseline for Duodopa non-naive participants was not done.	—
Electronic Diary: Morning and Day Scores (Free Tapping - Speed) From Baseline to Month 36 Morning, Month 0; n=19, 20, 15	40.6 taps/20 seconds Standard Deviation 14.1	44.4 taps/20 seconds Standard Deviation 12.5	39.2 taps/20 seconds Standard Deviation 14.2	—
Electronic Diary: Morning and Day Scores (Free Tapping - Speed) From Baseline to Month 36 Day, Month 0; n=19, 20, 15	40.3 taps/20 seconds Standard Deviation 13.0	43.5 taps/20 seconds Standard Deviation 11.5	40.2 taps/20 seconds Standard Deviation 12.5	—
Electronic Diary: Morning and Day Scores (Free Tapping - Speed) From Baseline to Month 36 Morning, Month 3; n=19, 18, 13	46.3 taps/20 seconds Standard Deviation 13.6	46.8 taps/20 seconds Standard Deviation 15.1	42.2 taps/20 seconds Standard Deviation 15.6	—
Electronic Diary: Morning and Day Scores (Free Tapping - Speed) From Baseline to Month 36 Day, Month 3; n=19, 19, 13	43.2 taps/20 seconds Standard Deviation 12.9	47.4 taps/20 seconds Standard Deviation 13.8	43.2 taps/20 seconds Standard Deviation 14.5	—
Electronic Diary: Morning and Day Scores (Free Tapping - Speed) From Baseline to Month 36 Morning, Month 6; n=16, 19, 11	48.0 taps/20 seconds Standard Deviation 14.3	50.7 taps/20 seconds Standard Deviation 15.5	43.4 taps/20 seconds Standard Deviation 17.5	—
Electronic Diary: Morning and Day Scores (Free Tapping - Speed) From Baseline to Month 36 Day, Month 6; n=16, 19, 11	47.6 taps/20 seconds Standard Deviation 12.0	50.3 taps/20 seconds Standard Deviation 14.9	43.0 taps/20 seconds Standard Deviation 15.8	—
Electronic Diary: Morning and Day Scores (Free Tapping - Speed) From Baseline to Month 36 Morning, Month 9; n=16, 17, 9	46.8 taps/20 seconds Standard Deviation 16.0	47.2 taps/20 seconds Standard Deviation 13.3	45.7 taps/20 seconds Standard Deviation 20.0	—
Electronic Diary: Morning and Day Scores (Free Tapping - Speed) From Baseline to Month 36 Morning, Month 12; n=16, 16, 9	47.0 taps/20 seconds Standard Deviation 18.8	49.3 taps/20 seconds Standard Deviation 16.0	44.5 taps/20 seconds Standard Deviation 16.1	—
Electronic Diary: Morning and Day Scores (Free Tapping - Speed) From Baseline to Month 36 Day, Month 12; n=16, 16, 9	46.6 taps/20 seconds Standard Deviation 18.5	48.7 taps/20 seconds Standard Deviation 17.6	46.6 taps/20 seconds Standard Deviation 15.1	—
Electronic Diary: Morning and Day Scores (Free Tapping - Speed) From Baseline to Month 36 Morning, Month 18; n=15, 14, 10	46.7 taps/20 seconds Standard Deviation 18.9	44.0 taps/20 seconds Standard Deviation 14.1	43.1 taps/20 seconds Standard Deviation 17.5	—
Electronic Diary: Morning and Day Scores (Free Tapping - Speed) From Baseline to Month 36 Day, Month 18; n=15, 14, 10	45.9 taps/20 seconds Standard Deviation 18.1	46.9 taps/20 seconds Standard Deviation 12.5	46.3 taps/20 seconds Standard Deviation 15.1	—
Electronic Diary: Morning and Day Scores (Free Tapping - Speed) From Baseline to Month 36 Morning, Month 24; n=13, 13, 7	38.7 taps/20 seconds Standard Deviation 14.7	47.3 taps/20 seconds Standard Deviation 14.9	45.5 taps/20 seconds Standard Deviation 17.6	—
Electronic Diary: Morning and Day Scores (Free Tapping - Speed) From Baseline to Month 36 Day, Month 24; n=13, 13, 7	41.5 taps/20 seconds Standard Deviation 12.9	47.6 taps/20 seconds Standard Deviation 15.0	48.7 taps/20 seconds Standard Deviation 14.2	—
Electronic Diary: Morning and Day Scores (Free Tapping - Speed) From Baseline to Month 36 Morning, Month 30; n=9, 9, 5	49.3 taps/20 seconds Standard Deviation 22.5	49.4 taps/20 seconds Standard Deviation 15.7	42.2 taps/20 seconds Standard Deviation 18.1	—
Electronic Diary: Morning and Day Scores (Free Tapping - Speed) From Baseline to Month 36 Day, Month 30; n=9, 9, 5	52.6 taps/20 seconds Standard Deviation 19.1	49.5 taps/20 seconds Standard Deviation 13.0	42.6 taps/20 seconds Standard Deviation 16.1	—
Electronic Diary: Morning and Day Scores (Free Tapping - Speed) From Baseline to Month 36 Morning, Month 36; n=6, 11, 5	51.4 taps/20 seconds Standard Deviation 25.0	46.3 taps/20 seconds Standard Deviation 14.0	44.7 taps/20 seconds Standard Deviation 18.6	—
Electronic Diary: Morning and Day Scores (Free Tapping - Speed) From Baseline to Month 36 Day, Month 36; n=5, 11, 5	50.5 taps/20 seconds Standard Deviation 23.6	45.5 taps/20 seconds Standard Deviation 8.5	45.6 taps/20 seconds Standard Deviation 19.7	—
Electronic Diary: Morning and Day Scores (Free Tapping - Speed) From Baseline to Month 36 Morning, Endpoint; n=23, 20, 16	43.1 taps/20 seconds Standard Deviation 16.8	41.8 taps/20 seconds Standard Deviation 11.6	41.2 taps/20 seconds Standard Deviation 16.8	—
Electronic Diary: Morning and Day Scores (Free Tapping - Speed) From Baseline to Month 36 Day, Endpoint; n=23, 20, 16	41.4 taps/20 seconds Standard Deviation 15.0	43.6 taps/20 seconds Standard Deviation 12.1	43.2 taps/20 seconds Standard Deviation 16.6	—

SECONDARY outcome

Timeframe: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)

Outcome measures

SECONDARY outcome

Timeframe: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)

Outcome measures

SECONDARY outcome

Timeframe: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)

Outcome measures

Outcome measures
Measure	Duodopa Non-naïve ≥ 2 Years n=18 Participants Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Duodopa Naïve n=27 Participants Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Duodopa Non-naïve < 2 Years n=22 Participants Duodopa non-naïve participants treated with Duodopa for \< 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Total All participants
Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Speed) From Baseline to Month 36 Morning, Month 24; n=13, 13, 7	22.7 taps/20 seconds Standard Deviation 5.1	27.0 taps/20 seconds Standard Deviation 5.2	24.8 taps/20 seconds Standard Deviation 5.6	—
Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Speed) From Baseline to Month 36 Morning, Month 30; n=9, 9, 5	25.1 taps/20 seconds Standard Deviation 7.0	27.4 taps/20 seconds Standard Deviation 4.6	24.4 taps/20 seconds Standard Deviation 6.1	—
Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Speed) From Baseline to Month 36 Morning, Month 36; n=6, 11, 5	25.1 taps/20 seconds Standard Deviation 6.8	26.5 taps/20 seconds Standard Deviation 5.3	23.1 taps/20 seconds Standard Deviation 6.7	—
Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Speed) From Baseline to Month 36 Day, Month 12; n=16, 16, 9	24.7 taps/20 seconds Standard Deviation 5.5	26.3 taps/20 seconds Standard Deviation 5.3	26.4 taps/20 seconds Standard Deviation 4.9	—
Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Speed) From Baseline to Month 36 Morning, Month 12; n=16, 16, 9	23.8 taps/20 seconds Standard Deviation 5.4	27.2 taps/20 seconds Standard Deviation 5.4	25.5 taps/20 seconds Standard Deviation 5.1	—
Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Speed) From Baseline to Month 36 Morning, Baseline (Month -3); n=20, 0, 0	NA taps/20 seconds Standard Deviation NA Baseline for Duodopa non-naive participants was not done.	24.5 taps/20 seconds Standard Deviation 4.1	NA taps/20 seconds Standard Deviation NA Baseline for Duodopa non-naive participants was not done.	—
Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Speed) From Baseline to Month 36 Day, Baseline (Month -3); n=20, 0, 0	NA taps/20 seconds Standard Deviation NA Baseline for Duodopa non-naive participants was not done.	24.2 taps/20 seconds Standard Deviation 4.2	NA taps/20 seconds Standard Deviation NA Baseline for Duodopa non-naive participants was not done.	—
Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Speed) From Baseline to Month 36 Morning, Month 0; n=19, 20, 15	22.7 taps/20 seconds Standard Deviation 4.7	26.3 taps/20 seconds Standard Deviation 4.8	22.6 taps/20 seconds Standard Deviation 5.8	—
Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Speed) From Baseline to Month 36 Day, Month 0; n=19, 20, 15	22.0 taps/20 seconds Standard Deviation 4.9	26.3 taps/20 seconds Standard Deviation 5.0	23.4 taps/20 seconds Standard Deviation 5.4	—
Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Speed) From Baseline to Month 36 Morning, Month 3; n=19, 18, 13	24.3 taps/20 seconds Standard Deviation 3.5	27.2 taps/20 seconds Standard Deviation 5.1	23.8 taps/20 seconds Standard Deviation 5.9	—
Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Speed) From Baseline to Month 36 Day, Month 3; n=19, 19, 13	24.0 taps/20 seconds Standard Deviation 3.9	27.2 taps/20 seconds Standard Deviation 4.7	24.4 taps/20 seconds Standard Deviation 6.3	—
Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Speed) From Baseline to Month 36 Morning, Month 6; n=16, 19, 11	24.4 taps/20 seconds Standard Deviation 4.1	28.3 taps/20 seconds Standard Deviation 4.7	24.2 taps/20 seconds Standard Deviation 5.3	—
Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Speed) From Baseline to Month 36 Day, Month 6; n=16, 19, 11	25.3 taps/20 seconds Standard Deviation 4.2	28.2 taps/20 seconds Standard Deviation 4.5	24.4 taps/20 seconds Standard Deviation 5.3	—
Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Speed) From Baseline to Month 36 Morning, Month 9; n=16, 17, 9	25.0 taps/20 seconds Standard Deviation 5.0	27.2 taps/20 seconds Standard Deviation 4.1	24.4 taps/20 seconds Standard Deviation 5.4	—
Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Speed) From Baseline to Month 36 Day, Month 9; n=16, 17, 9	25.6 taps/20 seconds Standard Deviation 4.7	27.0 taps/20 seconds Standard Deviation 4.5	25.6 taps/20 seconds Standard Deviation 4.4	—
Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Speed) From Baseline to Month 36 Morning, Month 18; n=15, 14, 10	24.8 taps/20 seconds Standard Deviation 6.1	26.2 taps/20 seconds Standard Deviation 4.1	24.9 taps/20 seconds Standard Deviation 6.4	—
Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Speed) From Baseline to Month 36 Day, Month 18; n=15, 14, 10	25.0 taps/20 seconds Standard Deviation 7.0	26.3 taps/20 seconds Standard Deviation 3.7	25.9 taps/20 seconds Standard Deviation 6.1	—
Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Speed) From Baseline to Month 36 Day, Month 24; n=13, 13, 7	23.8 taps/20 seconds Standard Deviation 4.6	26.7 taps/20 seconds Standard Deviation 5.6	26.5 taps/20 seconds Standard Deviation 5.1	—
Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Speed) From Baseline to Month 36 Day, Month 30; n=9, 9, 5	27.0 taps/20 seconds Standard Deviation 5.3	27.9 taps/20 seconds Standard Deviation 4.2	25.1 taps/20 seconds Standard Deviation 5.8	—
Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Speed) From Baseline to Month 36 Day, Month 36; n=5, 11, 5	26.3 taps/20 seconds Standard Deviation 6.3	25.2 taps/20 seconds Standard Deviation 2.4	23.9 taps/20 seconds Standard Deviation 6.3	—
Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Speed) From Baseline to Month 36 Morning, Endpoint; n=23, 20, 16	22.8 taps/20 seconds Standard Deviation 5.2	25.1 taps/20 seconds Standard Deviation 5.5	22.7 taps/20 seconds Standard Deviation 6.3	—
Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Speed) From Baseline to Month 36 Day, Endpoint; 23, 20, 16	23.0 taps/20 seconds Standard Deviation 6.3	25.1 taps/20 seconds Standard Deviation 4.8	23.6 taps/20 seconds Standard Deviation 6.2	—

SECONDARY outcome

Timeframe: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)

The Electronic Diary consisted of 15 items addressing motor performance, complication of therapy, self-assessment, and various types of tapping. Six conceptual dimensions were defined; four subjectively-reported: 'walking', 'satisfied', 'dyskinesia', and 'off' and two objectively-measured: 'tapping' and 'spiral'. Each of the items was assessed in the morning and during the day. Tapping: Random chase speed' is defined as the number of correct taps of fields randomly selected by the computer per 20 seconds. 'Tapping random chase - accuracy' is the percentage of accurate random chase taps.

Outcome measures

SECONDARY outcome

Timeframe: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)

Outcome measures

Outcome measures
Measure	Duodopa Non-naïve ≥ 2 Years n=18 Participants Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Duodopa Naïve n=27 Participants Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Duodopa Non-naïve < 2 Years n=22 Participants Duodopa non-naïve participants treated with Duodopa for \< 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Total All participants
Electronic Diary: Morning and Day Scores (Drawing Impairment [Wavelet Method]) From Baseline to Month 36 Day, Baseline (Month -3); n=20, 0, 0	NA units on a scale Standard Deviation NA Baseline for Duodopa non-naive participants was not done.	4.0 units on a scale Standard Deviation 1.2	NA units on a scale Standard Deviation NA Baseline for Duodopa non-naive participants was not done.	—
Electronic Diary: Morning and Day Scores (Drawing Impairment [Wavelet Method]) From Baseline to Month 36 Morning, Month 6; n=16, 19, 11	4.5 units on a scale Standard Deviation 1.4	3.8 units on a scale Standard Deviation 1.3	4.5 units on a scale Standard Deviation 1.7	—
Electronic Diary: Morning and Day Scores (Drawing Impairment [Wavelet Method]) From Baseline to Month 36 Day, Month 18; n=15, 14, 10	4.9 units on a scale Standard Deviation 1.8	4.6 units on a scale Standard Deviation 1.0	4.3 units on a scale Standard Deviation 1.5	—
Electronic Diary: Morning and Day Scores (Drawing Impairment [Wavelet Method]) From Baseline to Month 36 Morning, Month 0; n=19, 20, 15	5.0 units on a scale Standard Deviation 1.2	4.1 units on a scale Standard Deviation 1.4	4.5 units on a scale Standard Deviation 1.6	—
Electronic Diary: Morning and Day Scores (Drawing Impairment [Wavelet Method]) From Baseline to Month 36 Morning, Baseline (Month -3); n=20, 0, 0	NA units on a scale Standard Deviation NA Baseline for Duodopa non-naive participants was not done.	4.0 units on a scale Standard Deviation 1.4	NA units on a scale Standard Deviation NA Baseline for Duodopa non-naive participants was not done.	—
Electronic Diary: Morning and Day Scores (Drawing Impairment [Wavelet Method]) From Baseline to Month 36 Day, Month 0; n=19, 20, 15	5.1 units on a scale Standard Deviation 1.2	4.2 units on a scale Standard Deviation 1.3	4.3 units on a scale Standard Deviation 1.5	—
Electronic Diary: Morning and Day Scores (Drawing Impairment [Wavelet Method]) From Baseline to Month 36 Morning, Month 3; n=19, 18, 13	4.7 units on a scale Standard Deviation 1.5	3.6 units on a scale Standard Deviation 1.2	4.3 units on a scale Standard Deviation 1.5	—
Electronic Diary: Morning and Day Scores (Drawing Impairment [Wavelet Method]) From Baseline to Month 36 Day, Month 3; n=19, 19, 13	4.8 units on a scale Standard Deviation 1.5	3.8 units on a scale Standard Deviation 1.2	4.2 units on a scale Standard Deviation 1.4	—
Electronic Diary: Morning and Day Scores (Drawing Impairment [Wavelet Method]) From Baseline to Month 36 Day, Month 6; n=16, 19, 11	4.5 units on a scale Standard Deviation 1.7	4.1 units on a scale Standard Deviation 1.0	4.6 units on a scale Standard Deviation 1.6	—
Electronic Diary: Morning and Day Scores (Drawing Impairment [Wavelet Method]) From Baseline to Month 36 Morning, Month 9; n=16, 17, 9	4.6 units on a scale Standard Deviation 1.5	4.3 units on a scale Standard Deviation 1.2	4.1 units on a scale Standard Deviation 1.4	—
Electronic Diary: Morning and Day Scores (Drawing Impairment [Wavelet Method]) From Baseline to Month 36 Day, Month 9; n=16, 17, 9	4.5 units on a scale Standard Deviation 1.5	4.3 units on a scale Standard Deviation 1.0	4.1 units on a scale Standard Deviation 1.2	—
Electronic Diary: Morning and Day Scores (Drawing Impairment [Wavelet Method]) From Baseline to Month 36 Morning, Month 12; n=16, 16, 9	5.0 units on a scale Standard Deviation 1.4	4.1 units on a scale Standard Deviation 1.5	4.1 units on a scale Standard Deviation 1.2	—
Electronic Diary: Morning and Day Scores (Drawing Impairment [Wavelet Method]) From Baseline to Month 36 Day, Month 12; n=16, 16, 9	4.7 units on a scale Standard Deviation 1.4	4.4 units on a scale Standard Deviation 1.2	4.1 units on a scale Standard Deviation 1.3	—
Electronic Diary: Morning and Day Scores (Drawing Impairment [Wavelet Method]) From Baseline to Month 36 Morning, Month 18; n=15, 14, 10	5.4 units on a scale Standard Deviation 1.8	4.6 units on a scale Standard Deviation 1.3	4.4 units on a scale Standard Deviation 1.5	—
Electronic Diary: Morning and Day Scores (Drawing Impairment [Wavelet Method]) From Baseline to Month 36 Morning, Month 24; n=13, 13, 7	5.2 units on a scale Standard Deviation 1.7	4.3 units on a scale Standard Deviation 1.5	3.9 units on a scale Standard Deviation 1.3	—
Electronic Diary: Morning and Day Scores (Drawing Impairment [Wavelet Method]) From Baseline to Month 36 Day, Month 24; n=13, 13, 7	5.1 units on a scale Standard Deviation 1.7	4.5 units on a scale Standard Deviation 1.4	3.9 units on a scale Standard Deviation 1.1	—
Electronic Diary: Morning and Day Scores (Drawing Impairment [Wavelet Method]) From Baseline to Month 36 Morning, Month 30; n=9, 9, 5	4.9 units on a scale Standard Deviation 1.5	4.1 units on a scale Standard Deviation 1.4	4.4 units on a scale Standard Deviation 1.5	—
Electronic Diary: Morning and Day Scores (Drawing Impairment [Wavelet Method]) From Baseline to Month 36 Day, Month 30; n=9, 9, 5	4.8 units on a scale Standard Deviation 1.9	4.5 units on a scale Standard Deviation 1.2	4.4 units on a scale Standard Deviation 1.4	—
Electronic Diary: Morning and Day Scores (Drawing Impairment [Wavelet Method]) From Baseline to Month 36 Morning, Month 36; n=6, 11, 5	5.3 units on a scale Standard Deviation 1.6	4.4 units on a scale Standard Deviation 1.6	4.8 units on a scale Standard Deviation 1.8	—
Electronic Diary: Morning and Day Scores (Drawing Impairment [Wavelet Method]) From Baseline to Month 36 Day, Month 36; n=5, 11, 5	5.3 units on a scale Standard Deviation 1.3	5.0 units on a scale Standard Deviation 0.9	4.6 units on a scale Standard Deviation 1.5	—
Electronic Diary: Morning and Day Scores (Drawing Impairment [Wavelet Method]) From Baseline to Month 36 Morning, Endpoint; n=23, 20, 16	5.3 units on a scale Standard Deviation 1.3	4.5 units on a scale Standard Deviation 1.4	5.0 units on a scale Standard Deviation 1.8	—
Electronic Diary: Morning and Day Scores (Drawing Impairment [Wavelet Method]) From Baseline to Month 36 Day, Endpoint; n=23, 20, 16	5.3 units on a scale Standard Deviation 1.2	4.8 units on a scale Standard Deviation 1.2	4.9 units on a scale Standard Deviation 1.7	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Months 0, 3, 6, 9, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)

The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. For Parts I-III and Total Score, each question is measured on a 5-point scale of 0 (normal or no disease effect) to 4 (maximum negative effect). Part I score is the sum of answers to 'Mentation, Behavior and Mood' questions, with a score range from 0-16. Part II score is the sum of answers to 'Activities of Daily Living' questions, with a score range from 0-52. Part III score is the sum of answers to 'Motor Examination' questions, with a score range from 0-108. Total Score is the sum of the responses to the 31 questions (44 answers) that comprise Parts I-III of the scale, with a score range from 0-176. Higher scores are associated with more disability.

Outcome measures

Outcome measures
Measure	Duodopa Non-naïve ≥ 2 Years n=18 Participants Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Duodopa Naïve n=27 Participants Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Duodopa Non-naïve < 2 Years n=22 Participants Duodopa non-naïve participants treated with Duodopa for \< 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Total All participants
UPDRS Total Score up to Month 36 Month 0; n=27, 22, 18	47.8 units on a scale Standard Deviation 16.4	43.1 units on a scale Standard Deviation 16.7	46.2 units on a scale Standard Deviation 17.3	—
UPDRS Total Score up to Month 36 Month 3; n=24, 22, 18	46.8 units on a scale Standard Deviation 16.4	42.4 units on a scale Standard Deviation 19.1	45.5 units on a scale Standard Deviation 18.2	—
UPDRS Total Score up to Month 36 Month 6; n=25, 22, 18	47.4 units on a scale Standard Deviation 13.2	43.3 units on a scale Standard Deviation 21.4	43.5 units on a scale Standard Deviation 17.6	—
UPDRS Total Score up to Month 36 Month 9; 5, 20, 17	48.1 units on a scale Standard Deviation 17.8	40.8 units on a scale Standard Deviation 22.4	45.1 units on a scale Standard Deviation 13.0	—
UPDRS Total Score up to Month 36 Month 18; n=24, 20, 17	48.5 units on a scale Standard Deviation 18.0	45.2 units on a scale Standard Deviation 22.8	44.2 units on a scale Standard Deviation 16.1	—
UPDRS Total Score up to Month 36 Month 24; n=23, 18, 15	52.7 units on a scale Standard Deviation 15.5	44.5 units on a scale Standard Deviation 25.3	40.2 units on a scale Standard Deviation 15.9	—
UPDRS Total Score up to Month 36 Month 30; n=23, 17, 13	50.2 units on a scale Standard Deviation 19.8	47.1 units on a scale Standard Deviation 25.5	47.4 units on a scale Standard Deviation 19.0	—
UPDRS Total Score up to Month 36 Month 36; n=21, 16, 12	54.0 units on a scale Standard Deviation 25.3	46.2 units on a scale Standard Deviation 27.8	47.1 units on a scale Standard Deviation 14.3	—
UPDRS Total Score up to Month 36 Endpoint visit; n=27, 22, 18	55.0 units on a scale Standard Deviation 23.0	47.9 units on a scale Standard Deviation 25.8	50.8 units on a scale Standard Deviation 17.5	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Months 0, 3, 6, 9, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)

Outcome measures

Outcome measures
Measure	Duodopa Non-naïve ≥ 2 Years n=18 Participants Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Duodopa Naïve n=27 Participants Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Duodopa Non-naïve < 2 Years n=22 Participants Duodopa non-naïve participants treated with Duodopa for \< 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Total All participants
UPDRS Part I Score, up to Month 36 Month 0; n=27, 22, 18	2.7 units on a scale Standard Deviation 1.8	2.4 units on a scale Standard Deviation 1.8	2.0 units on a scale Standard Deviation 1.8	—
UPDRS Part I Score, up to Month 36 Month 3; n=24, 22, 18	3.2 units on a scale Standard Deviation 2.3	2.5 units on a scale Standard Deviation 1.7	2.0 units on a scale Standard Deviation 1.6	—
UPDRS Part I Score, up to Month 36 Month 6; n=25, 22, 18	2.9 units on a scale Standard Deviation 2.1	2.9 units on a scale Standard Deviation 1.9	2.3 units on a scale Standard Deviation 1.8	—
UPDRS Part I Score, up to Month 36 Month 9; n=25, 20, 17	3.3 units on a scale Standard Deviation 2.3	3.0 units on a scale Standard Deviation 1.9	2.9 units on a scale Standard Deviation 1.6	—
UPDRS Part I Score, up to Month 36 Month 18; n=24, 20, 17	3.3 units on a scale Standard Deviation 2.6	4.1 units on a scale Standard Deviation 3.0	2.7 units on a scale Standard Deviation 2.2	—
UPDRS Part I Score, up to Month 36 Month 24; n=23, 18, 15	3.5 units on a scale Standard Deviation 2.1	3.9 units on a scale Standard Deviation 2.8	3.0 units on a scale Standard Deviation 2.0	—
UPDRS Part I Score, up to Month 36 Month 30; n=23, 17, 13	2.8 units on a scale Standard Deviation 2.0	4.1 units on a scale Standard Deviation 3.2	3.5 units on a scale Standard Deviation 2.7	—
UPDRS Part I Score, up to Month 36 Month 36; n=21, 16, 12	3.8 units on a scale Standard Deviation 3.3	3.9 units on a scale Standard Deviation 3.1	3.9 units on a scale Standard Deviation 2.5	—
UPDRS Part I Score, up to Month 36 Endpoint visit; n=27, 22, 18	4.0 units on a scale Standard Deviation 2.8	3.9 units on a scale Standard Deviation 3.2	3.5 units on a scale Standard Deviation 2.6	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Months 0, 3, 6, 9, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)

The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. For Parts I-III and Total Score, each question is measured on a 5-point scale of 0 (normal or no disease effect) to 4 (maximum negative effect). Part II score is the sum of answers to 'Activities of Daily Living' questions, with a score range from 0-52. Higher scores are associated with more disability.

Outcome measures

Outcome measures
Measure	Duodopa Non-naïve ≥ 2 Years n=18 Participants Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Duodopa Naïve n=27 Participants Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Duodopa Non-naïve < 2 Years n=22 Participants Duodopa non-naïve participants treated with Duodopa for \< 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Total All participants
UPDRS Part II Score, up to Month 36 Month 6; n=25, 22, 18	14.3 units on a scale Standard Deviation 4.4	12.4 units on a scale Standard Deviation 6.7	13.4 units on a scale Standard Deviation 6.7	—
UPDRS Part II Score, up to Month 36 Month 24; n=23, 18, 15	17.2 units on a scale Standard Deviation 5.3	12.9 units on a scale Standard Deviation 7.7	12.2 units on a scale Standard Deviation 6.2	—
UPDRS Part II Score, up to Month 36 Month 0; n=27, 22, 18	15.4 units on a scale Standard Deviation 5.9	12.3 units on a scale Standard Deviation 5.1	13.7 units on a scale Standard Deviation 6.3	—
UPDRS Part II Score, up to Month 36 Month 3; n=24, 22, 18	15.0 units on a scale Standard Deviation 5.8	12.0 units on a scale Standard Deviation 5.7	12.8 units on a scale Standard Deviation 7.1	—
UPDRS Part II Score, up to Month 36 Month 9; n=25, 20, 17	14.4 units on a scale Standard Deviation 5.2	11.8 units on a scale Standard Deviation 6.9	13.0 units on a scale Standard Deviation 5.5	—
UPDRS Part II Score, up to Month 36 Month 18; n=24, 20, 17	15.6 units on a scale Standard Deviation 5.8	13.3 units on a scale Standard Deviation 7.2	12.9 units on a scale Standard Deviation 6.6	—
UPDRS Part II Score, up to Month 36 Month 30; n=23, 17, 13	16.9 units on a scale Standard Deviation 6.3	14.0 units on a scale Standard Deviation 8.5	14.6 units on a scale Standard Deviation 7.3	—
UPDRS Part II Score, up to Month 36 Month 36; n=21, 16, 12	16.8 units on a scale Standard Deviation 8.2	13.9 units on a scale Standard Deviation 8.4	14.6 units on a scale Standard Deviation 5.4	—
UPDRS Part II Score, up to Month 36 Endpoint visit; n=27, 22, 18	17.3 units on a scale Standard Deviation 7.0	14.6 units on a scale Standard Deviation 7.9	15.7 units on a scale Standard Deviation 6.4	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Months 0, 3, 6, 9, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)

Outcome measures

Outcome measures
Measure	Duodopa Non-naïve ≥ 2 Years n=18 Participants Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Duodopa Naïve n=27 Participants Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Duodopa Non-naïve < 2 Years n=22 Participants Duodopa non-naïve participants treated with Duodopa for \< 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Total All participants
UPDRS Part III Score, up to Month 36 Month 36; n=21, 16, 12	28.0 units on a scale Standard Deviation 15.8	22.0 units on a scale Standard Deviation 17.2	22.2 units on a scale Standard Deviation 7.9	—
UPDRS Part III Score, up to Month 36 Month 0; n=27, 22, 18	22.4 units on a scale Standard Deviation 9.8	22.0 units on a scale Standard Deviation 9.7	23.4 units on a scale Standard Deviation 11.1	—
UPDRS Part III Score, up to Month 36 Month 3; n=24, 22, 18	21.9 units on a scale Standard Deviation 9.5	21.6 units on a scale Standard Deviation 11.5	22.9 units on a scale Standard Deviation 11.3	—
UPDRS Part III Score, up to Month 36 Month 6; n=25, 20, 18	22.6 units on a scale Standard Deviation 8.6	21.5 units on a scale Standard Deviation 14.1	22.8 units on a scale Standard Deviation 9.9	—
UPDRS Part III Score, up to Month 36 Month 9; n=25, 20, 17	22.9 units on a scale Standard Deviation 11.8	19.9 units on a scale Standard Deviation 12.4	21.9 units on a scale Standard Deviation 8.1	—
UPDRS Part III Score, up to Month 36 Month 18; n=24, 20, 16	23.3 units on a scale Standard Deviation 11.1	21.3 units on a scale Standard Deviation 12.6	21.7 units on a scale Standard Deviation 9.3	—
UPDRS Part III Score, up to Month 36 Month 24; n=23, 18, 15	25.4 units on a scale Standard Deviation 9.2	21.4 units on a scale Standard Deviation 14.2	18.2 units on a scale Standard Deviation 9.8	—
UPDRS Part III Score, up to Month 36 Month 30; n=23, 17, 13	24.0 units on a scale Standard Deviation 12.1	23.1 units on a scale Standard Deviation 15.6	22.6 units on a scale Standard Deviation 11.5	—
UPDRS Part III Score, up to Month 36 Endpoint visit; n=27, 22, 17	28.6 units on a scale Standard Deviation 13.6	23.1 units on a scale Standard Deviation 15.8	24.1 units on a scale Standard Deviation 9.8	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Months 0, 3, 6, 9, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)

The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. For Part IV, questions are measured on a 5-point scale of 0 (normal or no disease effect) to 4 (maximum negative effect) or 2-point scale (0 or 1). Part IV score is the sum of answers to 'Complications of Therapy' questions, with a score range from 0-23. Higher scores are associated with more disability.

Outcome measures

Outcome measures
Measure	Duodopa Non-naïve ≥ 2 Years n=18 Participants Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Duodopa Naïve n=27 Participants Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Duodopa Non-naïve < 2 Years n=22 Participants Duodopa non-naïve participants treated with Duodopa for \< 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Total All participants
UPDRS Part IV Score, up to Month 36 Month 6; n=25, 22, 18	7.7 units on a scale Standard Deviation 3.2	6.5 units on a scale Standard Deviation 2.7	7.1 units on a scale Standard Deviation 2.8	—
UPDRS Part IV Score, up to Month 36 Month 18; n=24, 20, 17	7.6 units on a scale Standard Deviation 2.8	6.5 units on a scale Standard Deviation 3.3	7.0 units on a scale Standard Deviation 3.2	—
UPDRS Part IV Score, up to Month 36 Month 24; n=23, 18, 15	6.6 units on a scale Standard Deviation 2.5	6.3 units on a scale Standard Deviation 4.3	6.8 units on a scale Standard Deviation 3.6	—
UPDRS Part IV Score, up to Month 36 Month 30; n=22, 17, 13	6.5 units on a scale Standard Deviation 2.8	6.2 units on a scale Standard Deviation 3.7	6.6 units on a scale Standard Deviation 3.3	—
UPDRS Part IV Score, up to Month 36 Month 36; n=21, 16, 12	5.5 units on a scale Standard Deviation 1.8	6.4 units on a scale Standard Deviation 3.0	6.4 units on a scale Standard Deviation 2.4	—
UPDRS Part IV Score, up to Month 36 Endpoint visit; n=26, 22, 18	6.7 units on a scale Standard Deviation 2.7	6.5 units on a scale Standard Deviation 3.0	7.5 units on a scale Standard Deviation 3.0	—
UPDRS Part IV Score, up to Month 36 Month 9; n=25, 20, 17	7.5 units on a scale Standard Deviation 4.2	6.1 units on a scale Standard Deviation 3.3	7.3 units on a scale Standard Deviation 3.3	—
UPDRS Part IV Score, up to Month 36 Month 0; n=27, 22, 18	7.2 units on a scale Standard Deviation 3.0	6.5 units on a scale Standard Deviation 2.7	7.1 units on a scale Standard Deviation 3.4	—
UPDRS Part IV Score, up to Month 36 Month 3; n=24, 22, 18	6.7 units on a scale Standard Deviation 3.4	6.3 units on a scale Standard Deviation 2.9	7.8 units on a scale Standard Deviation 3.1	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Months 0, 3, 6, 9, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)

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

Outcome measures
Measure	Duodopa Non-naïve ≥ 2 Years n=18 Participants Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Duodopa Naïve n=27 Participants Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Duodopa Non-naïve < 2 Years n=22 Participants Duodopa non-naïve participants treated with Duodopa for \< 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Total All participants
EQ-5D Descriptive Systems Summary Index Score, up to Month 36 Month 9; n=25, 20, 17	0.59 units on a scale Standard Deviation 0.30	0.61 units on a scale Standard Deviation 0.33	0.66 units on a scale Standard Deviation 0.23	—
EQ-5D Descriptive Systems Summary Index Score, up to Month 36 Month 0; n=27, 22, 18	0.62 units on a scale Standard Deviation 0.24	0.67 units on a scale Standard Deviation 0.27	0.68 units on a scale Standard Deviation 0.27	—
EQ-5D Descriptive Systems Summary Index Score, up to Month 36 Month 3; n=24, 22, 18	0.57 units on a scale Standard Deviation 0.32	0.61 units on a scale Standard Deviation 0.30	0.70 units on a scale Standard Deviation 0.29	—
EQ-5D Descriptive Systems Summary Index Score, up to Month 36 Month 6; n=25, 21, 18	0.57 units on a scale Standard Deviation 0.32	0.64 units on a scale Standard Deviation 0.26	0.71 units on a scale Standard Deviation 0.22	—
EQ-5D Descriptive Systems Summary Index Score, up to Month 36 Month 18; n=24, 20, 16	0.53 units on a scale Standard Deviation 0.35	0.64 units on a scale Standard Deviation 0.23	0.66 units on a scale Standard Deviation 0.34	—
EQ-5D Descriptive Systems Summary Index Score, up to Month 36 Month 24; n=21, 18, 15	0.47 units on a scale Standard Deviation 0.32	0.58 units on a scale Standard Deviation 0.33	0.67 units on a scale Standard Deviation 0.26	—
EQ-5D Descriptive Systems Summary Index Score, up to Month 36 Month 30; n=22, 17, 12	0.52 units on a scale Standard Deviation 0.28	0.55 units on a scale Standard Deviation 0.28	0.69 units on a scale Standard Deviation 0.19	—
EQ-5D Descriptive Systems Summary Index Score, up to Month 36 Month 36; n=21, 15, 11	0.51 units on a scale Standard Deviation 0.25	0.52 units on a scale Standard Deviation 0.31	0.57 units on a scale Standard Deviation 0.28	—
EQ-5D Descriptive Systems Summary Index Score, up to Month 36 Endpoint visit; n=26, 22, 17	0.46 units on a scale Standard Deviation 0.33	0.54 units on a scale Standard Deviation 0.31	0.60 units on a scale Standard Deviation 0.25	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Months 0, 3, 6, 9, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)

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

Outcome measures
Measure	Duodopa Non-naïve ≥ 2 Years n=18 Participants Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Duodopa Naïve n=27 Participants Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Duodopa Non-naïve < 2 Years n=22 Participants Duodopa non-naïve participants treated with Duodopa for \< 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Total All participants
EQ-5D Visual Analog Scale (VAS) Score, up to Month 36 Month 0; n=27, 22, 18	0.58 units on a scale Standard Deviation 0.23	0.68 units on a scale Standard Deviation 0.18	0.65 units on a scale Standard Deviation 0.18	—
EQ-5D Visual Analog Scale (VAS) Score, up to Month 36 Month 9; n=25, 20, 17	0.58 units on a scale Standard Deviation 0.19	0.68 units on a scale Standard Deviation 0.14	0.69 units on a scale Standard Deviation 0.15	—
EQ-5D Visual Analog Scale (VAS) Score, up to Month 36 Month 24; n=21, 17, 15	0.63 units on a scale Standard Deviation 0.12	0.64 units on a scale Standard Deviation 0.18	0.60 units on a scale Standard Deviation 0.20	—
EQ-5D Visual Analog Scale (VAS) Score, up to Month 36 Month 3; n=24, 22, 18	0.58 units on a scale Standard Deviation 0.20	0.65 units on a scale Standard Deviation 0.19	0.63 units on a scale Standard Deviation 0.18	—
EQ-5D Visual Analog Scale (VAS) Score, up to Month 36 Month 6; n=25, 21, 18	0.59 units on a scale Standard Deviation 0.18	0.60 units on a scale Standard Deviation 0.22	0.65 units on a scale Standard Deviation 0.16	—
EQ-5D Visual Analog Scale (VAS) Score, up to Month 36 Month 18; n=24, 20, 16	0.55 units on a scale Standard Deviation 0.27	0.62 units on a scale Standard Deviation 0.20	0.60 units on a scale Standard Deviation 0.20	—
EQ-5D Visual Analog Scale (VAS) Score, up to Month 36 Month 30; n=22, 17, 12	0.65 units on a scale Standard Deviation 0.17	0.56 units on a scale Standard Deviation 0.20	0.67 units on a scale Standard Deviation 0.14	—
EQ-5D Visual Analog Scale (VAS) Score, up to Month 36 Month 36; n=21, 15, 11	0.62 units on a scale Standard Deviation 0.19	0.56 units on a scale Standard Deviation 0.17	0.61 units on a scale Standard Deviation 0.18	—
EQ-5D Visual Analog Scale (VAS) Score, up to Month 36 Endpoint visit; n=26, 22, 17	0.57 units on a scale Standard Deviation 0.21	0.57 units on a scale Standard Deviation 0.16	0.61 units on a scale Standard Deviation 0.17	—

Adverse Events

Duodopa Naïve

Serious events: 24 serious events

Other events: 29 other events

Deaths: 0 deaths

Duodopa Non-naïve < 2 Years

Serious events: 17 serious events

Other events: 22 other events

Deaths: 0 deaths

Duodopa Non-naïve ≥ 2 Years

Serious events: 14 serious events

Other events: 17 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

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

Measure	Duodopa Non-naïve ≥ 2 Years n=18 Participants Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Duodopa Naïve n=27 Participants Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Duodopa Non-naïve < 2 Years n=22 Participants Duodopa non-naïve participants treated with Duodopa for \< 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Total All participants
Electronic Diary: Morning and Day Scores (Off Time) From Baseline to Month 36 Day, Month 30; n=9, 9, 5	23.0 percentage of 'off' time Standard Deviation 11.2	21.6 percentage of 'off' time Standard Deviation 15.1	24.0 percentage of 'off' time Standard Deviation 13.4	—
Electronic Diary: Morning and Day Scores (Off Time) From Baseline to Month 36 Day, Month 36; n=5, 11, 5	23.6 percentage of 'off' time Standard Deviation 12.2	24.7 percentage of 'off' time Standard Deviation 19.4	18.8 percentage of 'off' time Standard Deviation 11.7	—
Electronic Diary: Morning and Day Scores (Off Time) From Baseline to Month 36 Day, Month 3; n=19, 19, 13	20.2 percentage of 'off' time Standard Deviation 10.3	23.0 percentage of 'off' time Standard Deviation 12.8	22.7 percentage of 'off' time Standard Deviation 13.9	—
Electronic Diary: Morning and Day Scores (Off Time) From Baseline to Month 36 Morning, Month 6; n=16, 19, 11	18.6 percentage of 'off' time Standard Deviation 10.9	25.6 percentage of 'off' time Standard Deviation 21.0	30.1 percentage of 'off' time Standard Deviation 21.1	—
Electronic Diary: Morning and Day Scores (Off Time) From Baseline to Month 36 Morning, Month 0; n=19, 20, 15	25.1 percentage of 'off' time Standard Deviation 12.7	23.4 percentage of 'off' time Standard Deviation 19.7	30.6 percentage of 'off' time Standard Deviation 21.2	—
Electronic Diary: Morning and Day Scores (Off Time) From Baseline to Month 36 Day, Month 0; n=19, 20, 15	25.7 percentage of 'off' time Standard Deviation 12.3	20.8 percentage of 'off' time Standard Deviation 14.6	21.4 percentage of 'off' time Standard Deviation 9.2	—
Electronic Diary: Morning and Day Scores (Off Time) From Baseline to Month 36 Morning, Month 3; n=19, 18, 13	25.7 percentage of 'off' time Standard Deviation 18.8	26.4 percentage of 'off' time Standard Deviation 20.2	34.3 percentage of 'off' time Standard Deviation 20.0	—
Electronic Diary: Morning and Day Scores (Off Time) From Baseline to Month 36 Morning, Baseline (Month -3); n=20, 0, 0	NA percentage of 'off' time Standard Deviation NA Baseline for Duodopa non-naive participants was not done.	41.2 percentage of 'off' time Standard Deviation 19.4	NA percentage of 'off' time Standard Deviation NA Baseline for Duodopa non-naive participants was not done.	—
Electronic Diary: Morning and Day Scores (Off Time) From Baseline to Month 36 Day, Baseline (Month -3); n=20, 0, 0	NA percentage of 'off' time Standard Deviation NA Baseline for Duodopa non-naive participants was not done.	35.4 percentage of 'off' time Standard Deviation 11.7	NA percentage of 'off' time Standard Deviation NA Baseline for Duodopa non-naive participants was not done.	—
Electronic Diary: Morning and Day Scores (Off Time) From Baseline to Month 36 Day, Month 6; n=16, 19, 11	20.9 percentage of 'off' time Standard Deviation 10.7	21.9 percentage of 'off' time Standard Deviation 13.3	21.8 percentage of 'off' time Standard Deviation 15.3	—
Electronic Diary: Morning and Day Scores (Off Time) From Baseline to Month 36 Morning, Month 9; n=16, 17, 9	23.6 percentage of 'off' time Standard Deviation 15.6	23.9 percentage of 'off' time Standard Deviation 18.4	32.3 percentage of 'off' time Standard Deviation 20.5	—
Electronic Diary: Morning and Day Scores (Off Time) From Baseline to Month 36 Day, Month 9; n=16, 17, 9	22.8 percentage of 'off' time Standard Deviation 11.6	19.5 percentage of 'off' time Standard Deviation 13.4	21.5 percentage of 'off' time Standard Deviation 10.8	—
Electronic Diary: Morning and Day Scores (Off Time) From Baseline to Month 36 Morning, Month 12; n=16, 16, 9	23.8 percentage of 'off' time Standard Deviation 16.0	25.3 percentage of 'off' time Standard Deviation 17.8	28.0 percentage of 'off' time Standard Deviation 23.3	—
Electronic Diary: Morning and Day Scores (Off Time) From Baseline to Month 36 Day, Month 12; n=16, 16, 9	23.5 percentage of 'off' time Standard Deviation 9.0	24.0 percentage of 'off' time Standard Deviation 17.3	19.5 percentage of 'off' time Standard Deviation 16.0	—
Electronic Diary: Morning and Day Scores (Off Time) From Baseline to Month 36 Morning, Month 18; n=15, 14, 10	24.9 percentage of 'off' time Standard Deviation 16.2	21.1 percentage of 'off' time Standard Deviation 13.0	28.9 percentage of 'off' time Standard Deviation 21.4	—
Electronic Diary: Morning and Day Scores (Off Time) From Baseline to Month 36 Day, Month 18; n=15, 14, 10	20.1 percentage of 'off' time Standard Deviation 11.9	17.9 percentage of 'off' time Standard Deviation 8.6	21.6 percentage of 'off' time Standard Deviation 13.8	—
Electronic Diary: Morning and Day Scores (Off Time) From Baseline to Month 36 Morning, Month 24; n=13, 13, 7	30.4 percentage of 'off' time Standard Deviation 17.9	29.1 percentage of 'off' time Standard Deviation 21.6	25.4 percentage of 'off' time Standard Deviation 16.0	—
Electronic Diary: Morning and Day Scores (Off Time) From Baseline to Month 36 Day, Month 24; n=13, 13, 7	24.9 percentage of 'off' time Standard Deviation 12.2	22.0 percentage of 'off' time Standard Deviation 15.5	21.3 percentage of 'off' time Standard Deviation 14.2	—
Electronic Diary: Morning and Day Scores (Off Time) From Baseline to Month 36 Morning, Month 30; n=9, 9, 5	28.0 percentage of 'off' time Standard Deviation 16.8	23.4 percentage of 'off' time Standard Deviation 19.8	29.4 percentage of 'off' time Standard Deviation 23.1	—
Electronic Diary: Morning and Day Scores (Off Time) From Baseline to Month 36 Morning, Month 36; n=6, 11, 5	31.5 percentage of 'off' time Standard Deviation 15.1	35.1 percentage of 'off' time Standard Deviation 25.2	29.4 percentage of 'off' time Standard Deviation 23.3	—
Electronic Diary: Morning and Day Scores (Off Time) From Baseline to Month 36 Morning, Endpoint; n=23, 20, 16	27.1 percentage of 'off' time Standard Deviation 13.8	30.7 percentage of 'off' time Standard Deviation 22.8	28.5 percentage of 'off' time Standard Deviation 21.4	—
Electronic Diary: Morning and Day Scores (Off Time) From Baseline to Month 36 Day, Endpoint; n=23, 20, 16	25.9 percentage of 'off' time Standard Deviation 11.7	24.8 percentage of 'off' time Standard Deviation 17.2	22.3 percentage of 'off' time Standard Deviation 14.2	—

Measure	Duodopa Non-naïve ≥ 2 Years n=18 Participants Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Duodopa Naïve n=27 Participants Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Duodopa Non-naïve < 2 Years n=22 Participants Duodopa non-naïve participants treated with Duodopa for \< 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Total All participants
Electronic Diary: Morning and Day Scores (On Time) From Baseline to Month 36 Day, Month 6; n=16, 19, 11	53.2 percentage of 'on' time Standard Deviation 29.7	62.2 percentage of 'on' time Standard Deviation 22.0	57.3 percentage of 'on' time Standard Deviation 21.3	—
Electronic Diary: Morning and Day Scores (On Time) From Baseline to Month 36 Morning, Baseline (Month -3); n=20, 0, 0	NA percentage of 'on' time Standard Deviation NA Baseline for Duodopa non-naive participants was not done.	40.2 percentage of 'on' time Standard Deviation 16.7	NA percentage of 'on' time Standard Deviation NA Baseline for Duodopa non-naive participants was not done.	—
Electronic Diary: Morning and Day Scores (On Time) From Baseline to Month 36 Day, Baseline (Month -3); n=20, 0, 0	NA percentage of 'on' time Standard Deviation NA Baseline for Duodopa non-naive participants was not done.	40.3 percentage of 'on' time Standard Deviation 14.0	NA percentage of 'on' time Standard Deviation NA Baseline for Duodopa non-naive participants was not done.	—
Electronic Diary: Morning and Day Scores (On Time) From Baseline to Month 36 Morning, Month 0; n=19, 20, 15	55.2 percentage of 'on' time Standard Deviation 27.1	58.4 percentage of 'on' time Standard Deviation 28.0	49.8 percentage of 'on' time Standard Deviation 23.1	—
Electronic Diary: Morning and Day Scores (On Time) From Baseline to Month 36 Day, Month 0; n=19, 20, 15	46.5 percentage of 'on' time Standard Deviation 28.0	61.8 percentage of 'on' time Standard Deviation 19.8	60.2 percentage of 'on' time Standard Deviation 14.8	—
Electronic Diary: Morning and Day Scores (On Time) From Baseline to Month 36 Morning, Month 3; n=19, 18, 13	49.8 percentage of 'on' time Standard Deviation 28.2	61.6 percentage of 'on' time Standard Deviation 23.6	52.0 percentage of 'on' time Standard Deviation 22.8	—
Electronic Diary: Morning and Day Scores (On Time) From Baseline to Month 36 Day, Month 3; n=19, 19, 13	55.0 percentage of 'on' time Standard Deviation 26.4	62.6 percentage of 'on' time Standard Deviation 17.8	58.3 percentage of 'on' time Standard Deviation 20.7	—
Electronic Diary: Morning and Day Scores (On Time) From Baseline to Month 36 Morning, Month 6; n=16, 19, 11	55.8 percentage of 'on' time Standard Deviation 31.1	57.7 percentage of 'on' time Standard Deviation 28.4	55.5 percentage of 'on' time Standard Deviation 24.1	—
Electronic Diary: Morning and Day Scores (On Time) From Baseline to Month 36 Morning, Month 9; n=16, 17, 9	47.9 percentage of 'on' time Standard Deviation 29.4	60.5 percentage of 'on' time Standard Deviation 25.1	52.3 percentage of 'on' time Standard Deviation 25.4	—
Electronic Diary: Morning and Day Scores (On Time) From Baseline to Month 36 Day, Month 9; n=16, 17, 9	50.8 percentage of 'on' time Standard Deviation 29.2	59.7 percentage of 'on' time Standard Deviation 23.4	59.5 percentage of 'on' time Standard Deviation 18.1	—
Electronic Diary: Morning and Day Scores (On Time) From Baseline to Month 36 Morning, Month 12; n=16, 16, 9	49.0 percentage of 'on' time Standard Deviation 32.2	61.1 percentage of 'on' time Standard Deviation 23.5	57.5 percentage of 'on' time Standard Deviation 23.4	—
Electronic Diary: Morning and Day Scores (On Time) From Baseline to Month 36 Day, Month 12; n=16, 16, 9	51.4 percentage of 'on' time Standard Deviation 26.9	59.5 percentage of 'on' time Standard Deviation 25.0	63.0 percentage of 'on' time Standard Deviation 21.9	—
Electronic Diary: Morning and Day Scores (On Time) From Baseline to Month 36 Morning, Month 18; n=15, 14, 10	51.1 percentage of 'on' time Standard Deviation 33.4	61.9 percentage of 'on' time Standard Deviation 21.4	55.2 percentage of 'on' time Standard Deviation 27.1	—
Electronic Diary: Morning and Day Scores (On Time) From Baseline to Month 36 Day, Month 18; n=15, 14, 10	52.5 percentage of 'on' time Standard Deviation 31.3	61.5 percentage of 'on' time Standard Deviation 17.9	57.6 percentage of 'on' time Standard Deviation 20.7	—
Electronic Diary: Morning and Day Scores (On Time) From Baseline to Month 36 Morning, Month 24; n=13, 13, 7	41.3 percentage of 'on' time Standard Deviation 22.0	61.3 percentage of 'on' time Standard Deviation 25.8	59.5 percentage of 'on' time Standard Deviation 23.1	—
Electronic Diary: Morning and Day Scores (On Time) From Baseline to Month 36 Day, Month 24; n=13, 13, 7	42.7 percentage of 'on' time Standard Deviation 24.8	62.3 percentage of 'on' time Standard Deviation 21.7	57.4 percentage of 'on' time Standard Deviation 23.8	—
Electronic Diary: Morning and Day Scores (On Time) From Baseline to Month 36 Morning, Month 30; n=9, 9, 5	58.6 percentage of 'on' time Standard Deviation 26.3	64.8 percentage of 'on' time Standard Deviation 28.3	49.3 percentage of 'on' time Standard Deviation 27.5	—
Electronic Diary: Morning and Day Scores (On Time) From Baseline to Month 36 Day, Month 30; n=9, 9, 5	58.8 percentage of 'on' time Standard Deviation 26.6	62.4 percentage of 'on' time Standard Deviation 27.3	56.9 percentage of 'on' time Standard Deviation 20.1	—
Electronic Diary: Morning and Day Scores (On Time) From Baseline to Month 36 Morning, Month 36; n=6, 11, 5	51.9 percentage of 'on' time Standard Deviation 26.8	54.5 percentage of 'on' time Standard Deviation 16.8	55.3 percentage of 'on' time Standard Deviation 23.4	—
Electronic Diary: Morning and Day Scores (On Time) From Baseline to Month 36 Day, Month 36; n=5, 11, 5	55.1 percentage of 'on' time Standard Deviation 28.2	59.1 percentage of 'on' time Standard Deviation 14.8	61.8 percentage of 'on' time Standard Deviation 18.8	—
Electronic Diary: Morning and Day Scores (On Time) From Baseline to Month 36 Morning, Endpoint; n=23, 20, 16	49.9 percentage of 'on' time Standard Deviation 23.5	52.9 percentage of 'on' time Standard Deviation 26.2	54.6 percentage of 'on' time Standard Deviation 21.8	—
Electronic Diary: Morning and Day Scores (On Time) From Baseline to Month 36 Day, Endpoint; n=23, 20, 16	46.2 percentage of 'on' time Standard Deviation 25.7	56.0 percentage of 'on' time Standard Deviation 21.2	56.5 percentage of 'on' time Standard Deviation 18.0	—

Measure	Duodopa Non-naïve ≥ 2 Years n=18 Participants Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Duodopa Naïve n=27 Participants Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Duodopa Non-naïve < 2 Years n=22 Participants Duodopa non-naïve participants treated with Duodopa for \< 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Total All participants
Electronic Diary: Morning and Day Scores (Dyskinetic Time) From Baseline to Month 36 Morning, Endpoint; n=23, 20, 16	23.0 percentage of 'dyskinetic' time Standard Deviation 15.5	16.5 percentage of 'dyskinetic' time Standard Deviation 21.4	16.9 percentage of 'dyskinetic' time Standard Deviation 11.6	—
Electronic Diary: Morning and Day Scores (Dyskinetic Time) From Baseline to Month 36 Morning, Month 36; n=6, 11, 5	16.6 percentage of 'dyskinetic' time Standard Deviation 18.0	10.4 percentage of 'dyskinetic' time Standard Deviation 9.8	15.2 percentage of 'dyskinetic' time Standard Deviation 10.3	—
Electronic Diary: Morning and Day Scores (Dyskinetic Time) From Baseline to Month 36 Day, Month 36; n=5, 11, 5	21.3 percentage of 'dyskinetic' time Standard Deviation 21.1	16.2 percentage of 'dyskinetic' time Standard Deviation 9.3	19.4 percentage of 'dyskinetic' time Standard Deviation 10.8	—
Electronic Diary: Morning and Day Scores (Dyskinetic Time) From Baseline to Month 36 Day, Endpoint; n=23, 20, 16	21.3 percentage of 'dyskinetic' time Standard Deviation 21.1	16.2 percentage of 'dyskinetic' time Standard Deviation 9.3	19.4 percentage of 'dyskinetic' time Standard Deviation 10.8	—
Electronic Diary: Morning and Day Scores (Dyskinetic Time) From Baseline to Month 36 Morning, Baseline (Month -3); n=20, 0, 0	NA percentage of 'dyskinetic' time Standard Deviation NA Baseline for Duodopa non-naive participants was not done.	18.6 percentage of 'dyskinetic' time Standard Deviation 12.4	NA percentage of 'dyskinetic' time Standard Deviation NA Baseline for Duodopa non-naive participants was not done.	—
Electronic Diary: Morning and Day Scores (Dyskinetic Time) From Baseline to Month 36 Day, Baseline (Month -3); n=20, 0, 0	NA percentage of 'dyskinetic' time Standard Deviation NA Baseline for Duodopa non-naive participants was not done.	24.3 percentage of 'dyskinetic' time Standard Deviation 14.4	NA percentage of 'dyskinetic' time Standard Deviation NA Baseline for Duodopa non-naive participants was not done.	—
Electronic Diary: Morning and Day Scores (Dyskinetic Time) From Baseline to Month 36 Morning, Month 0; n=19, 20, 15	19.7 percentage of 'dyskinetic' time Standard Deviation 17.5	18.2 percentage of 'dyskinetic' time Standard Deviation 24.2	19.6 percentage of 'dyskinetic' time Standard Deviation 17.8	—
Electronic Diary: Morning and Day Scores (Dyskinetic Time) From Baseline to Month 36 Day, Month 0; n=19, 20, 15	27.3 percentage of 'dyskinetic' time Standard Deviation 19.7	17.4 percentage of 'dyskinetic' time Standard Deviation 14.5	18.4 percentage of 'dyskinetic' time Standard Deviation 12.5	—
Electronic Diary: Morning and Day Scores (Dyskinetic Time) From Baseline to Month 36 Morning, Month 3; n=19, 18, 13	24.5 percentage of 'dyskinetic' time Standard Deviation 20.0	12.0 percentage of 'dyskinetic' time Standard Deviation 12.0	13.7 percentage of 'dyskinetic' time Standard Deviation 13.6	—
Electronic Diary: Morning and Day Scores (Dyskinetic Time) From Baseline to Month 36 Day, Month 3; n=19, 19, 13	24.8 percentage of 'dyskinetic' time Standard Deviation 21.3	14.4 percentage of 'dyskinetic' time Standard Deviation 13.0	18.9 percentage of 'dyskinetic' time Standard Deviation 16.5	—
Electronic Diary: Morning and Day Scores (Dyskinetic Time) From Baseline to Month 36 Morning, Month 6; n=16, 19, 11	25.6 percentage of 'dyskinetic' time Standard Deviation 24.3	16.7 percentage of 'dyskinetic' time Standard Deviation 17.3	14.4 percentage of 'dyskinetic' time Standard Deviation 12.9	—
Electronic Diary: Morning and Day Scores (Dyskinetic Time) From Baseline to Month 36 Day, Month 6; n=16, 19, 11	25.8 percentage of 'dyskinetic' time Standard Deviation 22.9	15.9 percentage of 'dyskinetic' time Standard Deviation 15.4	20.8 percentage of 'dyskinetic' time Standard Deviation 16.3	—
Electronic Diary: Morning and Day Scores (Dyskinetic Time) From Baseline to Month 36 Morning, Month 9; n=16, 17, 9	28.5 percentage of 'dyskinetic' time Standard Deviation 28.0	15.6 percentage of 'dyskinetic' time Standard Deviation 13.9	15.5 percentage of 'dyskinetic' time Standard Deviation 9.4	—
Electronic Diary: Morning and Day Scores (Dyskinetic Time) From Baseline to Month 36 Day, Month 9; n=16, 17, 9	26.5 percentage of 'dyskinetic' time Standard Deviation 22.8	20.8 percentage of 'dyskinetic' time Standard Deviation 15.4	19.0 percentage of 'dyskinetic' time Standard Deviation 12.0	—
Electronic Diary: Morning and Day Scores (Dyskinetic Time) From Baseline to Month 36 Morning, Month 12; n=16, 16, 9	27.2 percentage of 'dyskinetic' time Standard Deviation 24.8	13.6 percentage of 'dyskinetic' time Standard Deviation 13.2	14.6 percentage of 'dyskinetic' time Standard Deviation 10.4	—
Electronic Diary: Morning and Day Scores (Dyskinetic Time) From Baseline to Month 36 Day, Month 12; n=16, 16, 9	25.1 percentage of 'dyskinetic' time Standard Deviation 21.1	16.2 percentage of 'dyskinetic' time Standard Deviation 13.5	17.4 percentage of 'dyskinetic' time Standard Deviation 13.8	—
Electronic Diary: Morning and Day Scores (Dyskinetic Time) From Baseline to Month 36 Morning, Month 18; n=15, 14, 10	24.0 percentage of 'dyskinetic' time Standard Deviation 22.6	17.0 percentage of 'dyskinetic' time Standard Deviation 14.5	15.9 percentage of 'dyskinetic' time Standard Deviation 11.6	—
Electronic Diary: Morning and Day Scores (Dyskinetic Time) From Baseline to Month 36 Day, Month 18; n=15, 14, 10	27.4 percentage of 'dyskinetic' time Standard Deviation 21.2	20.6 percentage of 'dyskinetic' time Standard Deviation 11.9	20.8 percentage of 'dyskinetic' time Standard Deviation 11.0	—
Electronic Diary: Morning and Day Scores (Dyskinetic Time) From Baseline to Month 36 Morning, Month 24; n=13, 13, 7	28.2 percentage of 'dyskinetic' time Standard Deviation 19.5	9.6 percentage of 'dyskinetic' time Standard Deviation 12.0	15.0 percentage of 'dyskinetic' time Standard Deviation 11.9	—
Electronic Diary: Morning and Day Scores (Dyskinetic Time) From Baseline to Month 36 Day, Month 24; n=13, 13, 7	32.4 percentage of 'dyskinetic' time Standard Deviation 17.6	15.8 percentage of 'dyskinetic' time Standard Deviation 12.7	21.3 percentage of 'dyskinetic' time Standard Deviation 19.0	—
Electronic Diary: Morning and Day Scores (Dyskinetic Time) From Baseline to Month 36 Morning, Month 30; n=9, 9, 5	13.4 percentage of 'dyskinetic' time Standard Deviation 14.8	11.8 percentage of 'dyskinetic' time Standard Deviation 20.2	21.3 percentage of 'dyskinetic' time Standard Deviation 15.2	—
Electronic Diary: Morning and Day Scores (Dyskinetic Time) From Baseline to Month 36 Day, Month 30; n=9, 9, 5	18.2 percentage of 'dyskinetic' time Standard Deviation 16.9	14.5 percentage of 'dyskinetic' time Standard Deviation 16.8	19.1 percentage of 'dyskinetic' time Standard Deviation 12.1	—

Measure	Duodopa Non-naïve ≥ 2 Years n=18 Participants Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Duodopa Naïve n=27 Participants Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Duodopa Non-naïve < 2 Years n=22 Participants Duodopa non-naïve participants treated with Duodopa for \< 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Total All participants
Electronic Diary: Morning and Day Scores (Self-assessment) From Baseline to Month 36 Day, Month 3; n=19, 19, 13	0.3 units on a scale Standard Deviation 1.0	-0.3 units on a scale Standard Deviation 0.7	-0.1 units on a scale Standard Deviation 0.7	—
Electronic Diary: Morning and Day Scores (Self-assessment) From Baseline to Month 36 Day, Month 9; n=16, 17, 9	-0.1 units on a scale Standard Deviation 0.6	0.2 units on a scale Standard Deviation 0.8	-0.0 units on a scale Standard Deviation 0.5	—
Electronic Diary: Morning and Day Scores (Self-assessment) From Baseline to Month 36 Morning, Baseline (Month -3); n=20, 0, 0	NA units on a scale Standard Deviation NA Baseline for Duodopa non-naive participants was not done.	-0.9 units on a scale Standard Deviation 1.2	NA units on a scale Standard Deviation NA Baseline for Duodopa non-naive participants was not done.	—
Electronic Diary: Morning and Day Scores (Self-assessment) From Baseline to Month 36 Day, Baseline (Month -3); n=20, 0, 0	NA units on a scale Standard Deviation NA Baseline for Duodopa non-naive participants was not done.	-0.3 units on a scale Standard Deviation 1.1	NA units on a scale Standard Deviation NA Baseline for Duodopa non-naive participants was not done.	—
Electronic Diary: Morning and Day Scores (Self-assessment) From Baseline to Month 36 Morning, Month 0; n=19, 20, 15	0.2 units on a scale Standard Deviation 0.8	-0.4 units on a scale Standard Deviation 1.1	-0.1 units on a scale Standard Deviation 1.0	—
Electronic Diary: Morning and Day Scores (Self-assessment) From Baseline to Month 36 Day, Month 0; n=19, 20, 15	0.1 units on a scale Standard Deviation 1.0	-0.2 units on a scale Standard Deviation 0.9	-0.1 units on a scale Standard Deviation 0.6	—
Electronic Diary: Morning and Day Scores (Self-assessment) From Baseline to Month 36 Morning, Month 3; n=19, 18, 13	0.0 units on a scale Standard Deviation 0.8	-0.2 units on a scale Standard Deviation 0.9	-0.6 units on a scale Standard Deviation 0.9	—
Electronic Diary: Morning and Day Scores (Self-assessment) From Baseline to Month 36 Morning, Month 6; n=16, 19, 11	0.3 units on a scale Standard Deviation 0.7	-0.4 units on a scale Standard Deviation 1.0	-0.2 units on a scale Standard Deviation 1.0	—
Electronic Diary: Morning and Day Scores (Self-assessment) From Baseline to Month 36 Day, Month 6; n=16, 19, 11	0.3 units on a scale Standard Deviation 0.7	-0.2 units on a scale Standard Deviation 0.8	0.0 units on a scale Standard Deviation 0.8	—
Electronic Diary: Morning and Day Scores (Self-assessment) From Baseline to Month 36 Morning, Month 9; n=16, 17, 9	0.4 units on a scale Standard Deviation 1.0	-0.2 units on a scale Standard Deviation 0.8	-0.4 units on a scale Standard Deviation 0.7	—
Electronic Diary: Morning and Day Scores (Self-assessment) From Baseline to Month 36 Morning, Month 12; n=16, 16, 9	0.4 units on a scale Standard Deviation 0.6	-0.3 units on a scale Standard Deviation 0.8	-0.2 units on a scale Standard Deviation 0.9	—
Electronic Diary: Morning and Day Scores (Self-assessment) From Baseline to Month 36 Day, Month 12; n=16, 16, 9	0.1 units on a scale Standard Deviation 0.8	-0.3 units on a scale Standard Deviation 0.9	0.1 units on a scale Standard Deviation 0.8	—
Electronic Diary: Morning and Day Scores (Self-assessment) From Baseline to Month 36 Morning, Month 18; n=15, 14, 10	-0.0 units on a scale Standard Deviation 0.9	-0.3 units on a scale Standard Deviation 0.8	0.1 units on a scale Standard Deviation 0.8	—
Electronic Diary: Morning and Day Scores (Self-assessment) From Baseline to Month 36 Day, Month 18; n=15, 14, 10	0.1 units on a scale Standard Deviation 0.9	-0.2 units on a scale Standard Deviation 0.7	-0.2 units on a scale Standard Deviation 0.4	—
Electronic Diary: Morning and Day Scores (Self-assessment) From Baseline to Month 36 Morning, Month 24; n=13, 13, 7	0.1 units on a scale Standard Deviation 0.9	-0.5 units on a scale Standard Deviation 0.8	-0.0 units on a scale Standard Deviation 0.7	—
Electronic Diary: Morning and Day Scores (Self-assessment) From Baseline to Month 36 Day, Month 24; n=13, 13, 7	-0.0 units on a scale Standard Deviation 0.5	-0.2 units on a scale Standard Deviation 0.8	-0.1 units on a scale Standard Deviation 0.8	—
Electronic Diary: Morning and Day Scores (Self-assessment) From Baseline to Month 36 Morning, Month 30; n=9, 9, 5	0.2 units on a scale Standard Deviation 1.1	-0.4 units on a scale Standard Deviation 1.2	-0.2 units on a scale Standard Deviation 0.9	—
Electronic Diary: Morning and Day Scores (Self-assessment) From Baseline to Month 36 Day, Month 30; n=9, 9, 5	-0.3 units on a scale Standard Deviation 0.5	-0.3 units on a scale Standard Deviation 0.8	-0.3 units on a scale Standard Deviation 0.5	—
Electronic Diary: Morning and Day Scores (Self-assessment) From Baseline to Month 36 Morning, Month 36; n=6, 11, 5	0.3 units on a scale Standard Deviation 0.7	-0.9 units on a scale Standard Deviation 1.3	-0.0 units on a scale Standard Deviation 1.2	—
Electronic Diary: Morning and Day Scores (Self-assessment) From Baseline to Month 36 Day, Month 36; n=5, 11, 5	-0.2 units on a scale Standard Deviation 0.8	-0.2 units on a scale Standard Deviation 1.0	0.2 units on a scale Standard Deviation 0.5	—
Electronic Diary: Morning and Day Scores (Self-assessment) From Baseline to Month 36 Morning, Endpoint; n=23, 20, 16	0.2 units on a scale Standard Deviation 0.7	-0.6 units on a scale Standard Deviation 1.1	-0.2 units on a scale Standard Deviation 1.1	—
Electronic Diary: Morning and Day Scores (Self-assessment) From Baseline to Month 36 Day, Endpoint; n=23, 20, 16	0.2 units on a scale Standard Deviation 1.0	-0.3 units on a scale Standard Deviation 1.0	-0.0 units on a scale Standard Deviation 0.7	—

Measure	Duodopa Non-naïve ≥ 2 Years n=18 Participants Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Duodopa Naïve n=27 Participants Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Duodopa Non-naïve < 2 Years n=22 Participants Duodopa non-naïve participants treated with Duodopa for \< 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Total All participants
Electronic Diary: Morning and Day Scores (Free Tapping - Accuracy) From Baseline to Month 36 Day, Endpoint; n=23, 20, 16	60.3 percentage of tapping accuracy Standard Deviation 13.7	60.1 percentage of tapping accuracy Standard Deviation 15.8	62.7 percentage of tapping accuracy Standard Deviation 14.7	—
Electronic Diary: Morning and Day Scores (Free Tapping - Accuracy) From Baseline to Month 36 Morning, Baseline (Month -3); n=20, 0, 0	NA percentage of tapping accuracy Standard Deviation NA Baseline for Duodopa non-naive participants was not done.	70.7 percentage of tapping accuracy Standard Deviation 16.4	NA percentage of tapping accuracy Standard Deviation NA Baseline for Duodopa non-naive participants was not done.	—
Electronic Diary: Morning and Day Scores (Free Tapping - Accuracy) From Baseline to Month 36 Day, Baseline (Month -3); n=20, 0, 0	NA percentage of tapping accuracy Standard Deviation NA Baseline for Duodopa non-naive participants was not done.	71.9 percentage of tapping accuracy Standard Deviation 14.2	NA percentage of tapping accuracy Standard Deviation NA Baseline for Duodopa non-naive participants was not done.	—
Electronic Diary: Morning and Day Scores (Free Tapping - Accuracy) From Baseline to Month 36 Morning, Month 0; n=19, 20, 15	63.8 percentage of tapping accuracy Standard Deviation 13.1	71.4 percentage of tapping accuracy Standard Deviation 16.2	69.8 percentage of tapping accuracy Standard Deviation 13.8	—
Electronic Diary: Morning and Day Scores (Free Tapping - Accuracy) From Baseline to Month 36 Day, Month 0; n=19, 20, 15	65.2 percentage of tapping accuracy Standard Deviation 10.1	70.1 percentage of tapping accuracy Standard Deviation 14.6	70.7 percentage of tapping accuracy Standard Deviation 12.4	—
Electronic Diary: Morning and Day Scores (Free Tapping - Accuracy) From Baseline to Month 36 Morning, Month 3; n=19, 18, 13	63.5 percentage of tapping accuracy Standard Deviation 13.4	73.4 percentage of tapping accuracy Standard Deviation 13.0	70.3 percentage of tapping accuracy Standard Deviation 13.9	—
Electronic Diary: Morning and Day Scores (Free Tapping - Accuracy) From Baseline to Month 36 Day, Month 3; n=19, 19, 13	65.8 percentage of tapping accuracy Standard Deviation 12.9	70.0 percentage of tapping accuracy Standard Deviation 14.4	69.7 percentage of tapping accuracy Standard Deviation 12.4	—
Electronic Diary: Morning and Day Scores (Free Tapping - Accuracy) From Baseline to Month 36 Morning, Month 6; n=16, 19, 11	64.8 percentage of tapping accuracy Standard Deviation 17.2	67.6 percentage of tapping accuracy Standard Deviation 9.4	66.2 percentage of tapping accuracy Standard Deviation 13.8	—
Electronic Diary: Morning and Day Scores (Free Tapping - Accuracy) From Baseline to Month 36 Day, Month 6; n=16, 19, 11	66.7 percentage of tapping accuracy Standard Deviation 14.1	65.7 percentage of tapping accuracy Standard Deviation 13.0	66.1 percentage of tapping accuracy Standard Deviation 12.6	—
Electronic Diary: Morning and Day Scores (Free Tapping - Accuracy) From Baseline to Month 36 Morning, Month 9; n=16, 17, 9	65.8 percentage of tapping accuracy Standard Deviation 14.2	67.0 percentage of tapping accuracy Standard Deviation 13.3	63.6 percentage of tapping accuracy Standard Deviation 16.9	—
Electronic Diary: Morning and Day Scores (Free Tapping - Accuracy) From Baseline to Month 36 Day, Month 9; n=16, 17, 9	67.5 percentage of tapping accuracy Standard Deviation 10.9	65.4 percentage of tapping accuracy Standard Deviation 9.3	69.9 percentage of tapping accuracy Standard Deviation 13.4	—
Electronic Diary: Morning and Day Scores (Free Tapping - Accuracy) From Baseline to Month 36 Morning, Month 12; n=16, 16, 9	61.5 percentage of tapping accuracy Standard Deviation 8.8	68.7 percentage of tapping accuracy Standard Deviation 15.3	71.5 percentage of tapping accuracy Standard Deviation 14.4	—
Electronic Diary: Morning and Day Scores (Free Tapping - Accuracy) From Baseline to Month 36 Day, Month 12; n=16, 16, 9	60.4 percentage of tapping accuracy Standard Deviation 9.1	64.7 percentage of tapping accuracy Standard Deviation 16.9	71.7 percentage of tapping accuracy Standard Deviation 11.9	—
Electronic Diary: Morning and Day Scores (Free Tapping - Accuracy) From Baseline to Month 36 Morning, Month 18; n=15, 14, 10	65.8 percentage of tapping accuracy Standard Deviation 13.3	58.9 percentage of tapping accuracy Standard Deviation 10.8	65.4 percentage of tapping accuracy Standard Deviation 18.2	—
Electronic Diary: Morning and Day Scores (Free Tapping - Accuracy) From Baseline to Month 36 Day, Month 18; n=15, 14, 10	61.4 percentage of tapping accuracy Standard Deviation 12.7	61.2 percentage of tapping accuracy Standard Deviation 11.0	69.1 percentage of tapping accuracy Standard Deviation 12.3	—
Electronic Diary: Morning and Day Scores (Free Tapping - Accuracy) From Baseline to Month 36 Morning, Month 24; n=13, 13, 7	61.9 percentage of tapping accuracy Standard Deviation 14.3	62.3 percentage of tapping accuracy Standard Deviation 16.9	66.2 percentage of tapping accuracy Standard Deviation 16.7	—
Electronic Diary: Morning and Day Scores (Free Tapping - Accuracy) From Baseline to Month 36 Day, Month 24; n=13, 13, 7	62.4 percentage of tapping accuracy Standard Deviation 11.7	64.4 percentage of tapping accuracy Standard Deviation 14.5	69.1 percentage of tapping accuracy Standard Deviation 15.9	—
Electronic Diary: Morning and Day Scores (Free Tapping - Accuracy) From Baseline to Month 36 Morning, Month 30; n=9, 9, 5	62.1 percentage of tapping accuracy Standard Deviation 13.6	66.3 percentage of tapping accuracy Standard Deviation 10.6	67.2 percentage of tapping accuracy Standard Deviation 12.8	—
Electronic Diary: Morning and Day Scores (Free Tapping - Accuracy) From Baseline to Month 36 Day, Month 30; n=9, 9, 5	67.9 percentage of tapping accuracy Standard Deviation 10.5	66.8 percentage of tapping accuracy Standard Deviation 12.1	67.3 percentage of tapping accuracy Standard Deviation 12.3	—
Electronic Diary: Morning and Day Scores (Free Tapping - Accuracy) From Baseline to Month 36 Morning, Month 36; n=6, 11, 5	61.2 percentage of tapping accuracy Standard Deviation 12.6	60.7 percentage of tapping accuracy Standard Deviation 24.1	60.3 percentage of tapping accuracy Standard Deviation 19.3	—
Electronic Diary: Morning and Day Scores (Free Tapping - Accuracy) From Baseline to Month 36 Day, Month 36; n=5, 11, 5	63.6 percentage of tapping accuracy Standard Deviation 11.2	50.3 percentage of tapping accuracy Standard Deviation 13.0	64.6 percentage of tapping accuracy Standard Deviation 15.5	—
Electronic Diary: Morning and Day Scores (Free Tapping - Accuracy) From Baseline to Month 36 Morning, Endpoint; n=23, 20, 16	59.3 percentage of tapping accuracy Standard Deviation 13.6	63.7 percentage of tapping accuracy Standard Deviation 17.1	58.7 percentage of tapping accuracy Standard Deviation 17.0	—

Measure	Duodopa Non-naïve ≥ 2 Years n=18 Participants Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Duodopa Naïve n=27 Participants Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Duodopa Non-naïve < 2 Years n=22 Participants Duodopa non-naïve participants treated with Duodopa for \< 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Total All participants
Electronic Diary: Morning and Day Scores (Tapping, Increased Speed - Accuracy) From Baseline to Month 36 Morning, Baseline (Month -3); n=20, 0, 0	NA percentage of accurate taps Standard Deviation NA Baseline for Duodopa non-naive participants was not done.	74.6 percentage of accurate taps Standard Deviation 13.9	NA percentage of accurate taps Standard Deviation NA Baseline for Duodopa non-naive participants was not done.	—
Electronic Diary: Morning and Day Scores (Tapping, Increased Speed - Accuracy) From Baseline to Month 36 Day, Baseline (Month -3); n=20, 0, 0	NA percentage of accurate taps Standard Deviation NA Baseline for Duodopa non-naive participants was not done.	73.7 percentage of accurate taps Standard Deviation 14.7	NA percentage of accurate taps Standard Deviation NA Baseline for Duodopa non-naive participants was not done.	—
Electronic Diary: Morning and Day Scores (Tapping, Increased Speed - Accuracy) From Baseline to Month 36 Morning, Month 0; n=19, 20, 15	73.2 percentage of accurate taps Standard Deviation 15.1	83.7 percentage of accurate taps Standard Deviation 12.0	71.0 percentage of accurate taps Standard Deviation 24.8	—
Electronic Diary: Morning and Day Scores (Tapping, Increased Speed - Accuracy) From Baseline to Month 36 Day, Month 0; n=19, 20, 15	73.2 percentage of accurate taps Standard Deviation 13.8	80.4 percentage of accurate taps Standard Deviation 10.6	73.9 percentage of accurate taps Standard Deviation 18.6	—
Electronic Diary: Morning and Day Scores (Tapping, Increased Speed - Accuracy) From Baseline to Month 36 Morning, Month 3; n=19, 18, 13	68.8 percentage of accurate taps Standard Deviation 22.7	83.1 percentage of accurate taps Standard Deviation 14.8	73.5 percentage of accurate taps Standard Deviation 22.3	—
Electronic Diary: Morning and Day Scores (Tapping, Increased Speed - Accuracy) From Baseline to Month 36 Day, Month 3; n=19, 19, 13	69.3 percentage of accurate taps Standard Deviation 20.2	81.3 percentage of accurate taps Standard Deviation 14.5	74.7 percentage of accurate taps Standard Deviation 20.5	—
Electronic Diary: Morning and Day Scores (Tapping, Increased Speed - Accuracy) From Baseline to Month 36 Morning, Month 6; n=16, 19, 11	73.3 percentage of accurate taps Standard Deviation 20.1	87.1 percentage of accurate taps Standard Deviation 11.0	74.2 percentage of accurate taps Standard Deviation 22.1	—
Electronic Diary: Morning and Day Scores (Tapping, Increased Speed - Accuracy) From Baseline to Month 36 Day, Month 6; n=16, 19, 11	73.0 percentage of accurate taps Standard Deviation 21.2	87.8 percentage of accurate taps Standard Deviation 9.8	73.6 percentage of accurate taps Standard Deviation 20.3	—
Electronic Diary: Morning and Day Scores (Tapping, Increased Speed - Accuracy) From Baseline to Month 36 Morning, Month 9; n=16, 17, 9	77.1 percentage of accurate taps Standard Deviation 16.9	86.4 percentage of accurate taps Standard Deviation 11.1	78.2 percentage of accurate taps Standard Deviation 19.0	—
Electronic Diary: Morning and Day Scores (Tapping, Increased Speed - Accuracy) From Baseline to Month 36 Day, Month 9; n=16, 17, 9	75.6 percentage of accurate taps Standard Deviation 19.0	86.0 percentage of accurate taps Standard Deviation 10.1	78.8 percentage of accurate taps Standard Deviation 15.3	—
Electronic Diary: Morning and Day Scores (Tapping, Increased Speed - Accuracy) From Baseline to Month 36 Morning, Month 12; n=16, 16, 9	74.6 percentage of accurate taps Standard Deviation 20.0	87.0 percentage of accurate taps Standard Deviation 12.5	80.1 percentage of accurate taps Standard Deviation 18.6	—
Electronic Diary: Morning and Day Scores (Tapping, Increased Speed - Accuracy) From Baseline to Month 36 Day, Month 12; n=16, 16, 9	72.4 percentage of accurate taps Standard Deviation 23.6	81.8 percentage of accurate taps Standard Deviation 15.6	77.5 percentage of accurate taps Standard Deviation 20.9	—
Electronic Diary: Morning and Day Scores (Tapping, Increased Speed - Accuracy) From Baseline to Month 36 Morning, Month 18; n=15, 14, 10	71.4 percentage of accurate taps Standard Deviation 25.8	81.3 percentage of accurate taps Standard Deviation 13.9	77.9 percentage of accurate taps Standard Deviation 18.5	—
Electronic Diary: Morning and Day Scores (Tapping, Increased Speed - Accuracy) From Baseline to Month 36 Day, Month 18; n=15, 14, 10	72.1 percentage of accurate taps Standard Deviation 24.4	82.1 percentage of accurate taps Standard Deviation 12.9	78.7 percentage of accurate taps Standard Deviation 19.2	—
Electronic Diary: Morning and Day Scores (Tapping, Increased Speed - Accuracy) From Baseline to Month 36 Morning, Month 24; n=13, 13, 7	69.0 percentage of accurate taps Standard Deviation 18.9	85.7 percentage of accurate taps Standard Deviation 13.1	79.4 percentage of accurate taps Standard Deviation 20.6	—
Electronic Diary: Morning and Day Scores (Tapping, Increased Speed - Accuracy) From Baseline to Month 36 Day, Month 24; n=13, 13, 7	70.0 percentage of accurate taps Standard Deviation 16.9	85.3 percentage of accurate taps Standard Deviation 10.6	82.0 percentage of accurate taps Standard Deviation 15.9	—
Electronic Diary: Morning and Day Scores (Tapping, Increased Speed - Accuracy) From Baseline to Month 36 Morning, Month 30; n=9, 9, 5	79.8 percentage of accurate taps Standard Deviation 18.1	87.3 percentage of accurate taps Standard Deviation 5.1	73.5 percentage of accurate taps Standard Deviation 21.1	—
Electronic Diary: Morning and Day Scores (Tapping, Increased Speed - Accuracy) From Baseline to Month 36 Day, Month 30; n=9, 9, 5	80.6 percentage of accurate taps Standard Deviation 20.5	88.6 percentage of accurate taps Standard Deviation 6.4	74.5 percentage of accurate taps Standard Deviation 19.7	—
Electronic Diary: Morning and Day Scores (Tapping, Increased Speed - Accuracy) From Baseline to Month 36 Morning, Month 36; n=6, 11, 5	81.0 percentage of accurate taps Standard Deviation 17.3	77.9 percentage of accurate taps Standard Deviation 18.8	71.7 percentage of accurate taps Standard Deviation 24.9	—
Electronic Diary: Morning and Day Scores (Tapping, Increased Speed - Accuracy) From Baseline to Month 36 Day, Month 36; n=5, 11, 5	77.9 percentage of accurate taps Standard Deviation 21.1	70.7 percentage of accurate taps Standard Deviation 15.9	72.8 percentage of accurate taps Standard Deviation 21.8	—
Electronic Diary: Morning and Day Scores (Tapping, Increased Speed - Accuracy) From Baseline to Month 36 Morning, Endpoint; n=23, 20, 16	68.0 percentage of accurate taps Standard Deviation 19.7	79.5 percentage of accurate taps Standard Deviation 17.7	70.4 percentage of accurate taps Standard Deviation 23.8	—
Electronic Diary: Morning and Day Scores (Tapping, Increased Speed - Accuracy) From Baseline to Month 36 Day, Endpoint; n=23, 20, 16	67.5 percentage of accurate taps Standard Deviation 20.5	74.6 percentage of accurate taps Standard Deviation 17.4	72.0 percentage of accurate taps Standard Deviation 22.2	—

Measure	Duodopa Non-naïve ≥ 2 Years n=18 Participants Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Duodopa Naïve n=27 Participants Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Duodopa Non-naïve < 2 Years n=22 Participants Duodopa non-naïve participants treated with Duodopa for \< 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.	Total All participants
Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Accuracy) From Baseline to Month 36 Morning, Month 0; n=19, 20, 15	92.6 percentage of accurate taps Standard Deviation 6.3	94.6 percentage of accurate taps Standard Deviation 4.5	90.0 percentage of accurate taps Standard Deviation 12.6	—
Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Accuracy) From Baseline to Month 36 Day, Month 0; n=19, 20, 15	92.3 percentage of accurate taps Standard Deviation 7.0	92.9 percentage of accurate taps Standard Deviation 6.8	91.3 percentage of accurate taps Standard Deviation 10.6	—
Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Accuracy) From Baseline to Month 36 Morning, Month 3; n=19, 18, 13	89.1 percentage of accurate taps Standard Deviation 10.1	90.5 percentage of accurate taps Standard Deviation 17.3	89.2 percentage of accurate taps Standard Deviation 11.6	—
Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Accuracy) From Baseline to Month 36 Morning, Month 18; n=15, 14, 10	86.8 percentage of accurate taps Standard Deviation 13.9	90.2 percentage of accurate taps Standard Deviation 11.3	88.8 percentage of accurate taps Standard Deviation 14.6	—
Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Accuracy) From Baseline to Month 36 Morning, Month 30; n=9, 9, 5	90.5 percentage of accurate taps Standard Deviation 9.1	95.1 percentage of accurate taps Standard Deviation 3.3	85.9 percentage of accurate taps Standard Deviation 11.5	—
Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Accuracy) From Baseline to Month 36 Morning, Endpoint; n=23, 20, 16	87.5 percentage of accurate taps Standard Deviation 8.1	87.8 percentage of accurate taps Standard Deviation 18.7	83.8 percentage of accurate taps Standard Deviation 15.1	—
Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Accuracy) From Baseline to Month 36 Morning, Month 24; n=13, 13, 7	89.0 percentage of accurate taps Standard Deviation 7.7	91.7 percentage of accurate taps Standard Deviation 10.2	92.2 percentage of accurate taps Standard Deviation 9.6	—
Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Accuracy) From Baseline to Month 36 Day, Month 24; n=13, 13, 7	90.7 percentage of accurate taps Standard Deviation 6.3	92.9 percentage of accurate taps Standard Deviation 6.7	93.4 percentage of accurate taps Standard Deviation 5.2	—
Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Accuracy) From Baseline to Month 36 Day, Month 30; n=9, 9, 5	91.2 percentage of accurate taps Standard Deviation 7.2	93.6 percentage of accurate taps Standard Deviation 4.9	88.6 percentage of accurate taps Standard Deviation 8.6	—
Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Accuracy) From Baseline to Month 36 Morning, Month 36; n=6, 11, 5	89.7 percentage of accurate taps Standard Deviation 7.0	83.5 percentage of accurate taps Standard Deviation 19.8	85.9 percentage of accurate taps Standard Deviation 14.8	—
Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Accuracy) From Baseline to Month 36 Day, Month 36; n=5, 11, 5	88.8 percentage of accurate taps Standard Deviation 7.5	82.1 percentage of accurate taps Standard Deviation 16.9	88.4 percentage of accurate taps Standard Deviation 11.8	—
Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Accuracy) From Baseline to Month 36 Day, Endpoint; n=23, 20, 16	86.7 percentage of accurate taps Standard Deviation 9.6	87.3 percentage of accurate taps Standard Deviation 12.6	86.6 percentage of accurate taps Standard Deviation 14.3	—
Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Accuracy) From Baseline to Month 36 Morning, Baseline (Month -3); n=20, 0, 0	NA percentage of accurate taps Standard Deviation NA Baseline for Duodopa non-naive participants was not done.	92.0 percentage of accurate taps Standard Deviation 14.2	NA percentage of accurate taps Standard Deviation NA Baseline for Duodopa non-naive participants was not done.	—
Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Accuracy) From Baseline to Month 36 Day, Baseline (Month -3); n=20, 0, 0	NA percentage of accurate taps Standard Deviation NA Baseline for Duodopa non-naive participants was not done.	91.8 percentage of accurate taps Standard Deviation 7.8	NA percentage of accurate taps Standard Deviation NA Baseline for Duodopa non-naive participants was not done.	—
Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Accuracy) From Baseline to Month 36 Day, Month 3; n=19, 19, 13	89.8 percentage of accurate taps Standard Deviation 8.0	92.5 percentage of accurate taps Standard Deviation 9.8	88.6 percentage of accurate taps Standard Deviation 13.6	—
Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Accuracy) From Baseline to Month 36 Morning, Month 6; n=16, 19, 11	90.5 percentage of accurate taps Standard Deviation 7.7	95.2 percentage of accurate taps Standard Deviation 4.4	89.0 percentage of accurate taps Standard Deviation 14.2	—
Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Accuracy) From Baseline to Month 36 Day, Month 6; n=16, 19, 11	89.2 percentage of accurate taps Standard Deviation 11.6	94.6 percentage of accurate taps Standard Deviation 3.5	88.7 percentage of accurate taps Standard Deviation 14.0	—
Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Accuracy) From Baseline to Month 36 Morning, Month 9; n=16, 17, 9	91.8 percentage of accurate taps Standard Deviation 6.3	91.2 percentage of accurate taps Standard Deviation 8.1	90.8 percentage of accurate taps Standard Deviation 10.5	—
Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Accuracy) From Baseline to Month 36 Day, Month 9; n=16, 17, 9	92.5 percentage of accurate taps Standard Deviation 4.8	92.4 percentage of accurate taps Standard Deviation 7.7	93.1 percentage of accurate taps Standard Deviation 7.2	—
Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Accuracy) From Baseline to Month 36 Morning, Month 12; n=16, 16, 9	90.6 percentage of accurate taps Standard Deviation 5.9	92.2 percentage of accurate taps Standard Deviation 8.8	90.7 percentage of accurate taps Standard Deviation 11.4	—
Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Accuracy) From Baseline to Month 36 Day, Month 12; n=16, 16, 9	89.2 percentage of accurate taps Standard Deviation 7.9	91.2 percentage of accurate taps Standard Deviation 7.6	92.5 percentage of accurate taps Standard Deviation 8.0	—
Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Accuracy) From Baseline to Month 36 Day, Month 18; n=15, 14, 10	85.4 percentage of accurate taps Standard Deviation 15.4	91.6 percentage of accurate taps Standard Deviation 5.5	92.1 percentage of accurate taps Standard Deviation 9.2	—