Trial Outcomes & Findings for A Study to Evaluate the Efficacy of 18 to 24mg/Day Ropinirole Controlled Release (CR) Tablets in Early and Advanced Parkinson's Disease (PD) Patients. (NCT NCT01929317)

NCT ID: NCT01929317

Last Updated: 2018-06-20

Results Overview

The Japanese Unified Parkinson's Disease Rating Scale (UPDRS) assesses the status of Parkinson's Disease (PD) participants objectively. Part III assessed motor examination on 27 items. Participants received a score of 0-4 points per item. The maximum total score is 108 points. A higher score indicates more severe PD symptoms. Baseline is defined as the value evaluated at Week 0. Mean change from Baseline was calculated as the total score at Week 12 minus the total score at Baseline. The analyses for the Dose Increase Effect Verification Phase was performed using the last observation carried forward (LOCF) data. In the LOCF data, the last available data was used for the imputation for missing data at a planned visit. The imputation was conducted using the data within only the Dose Increase Effect Verification Phase; therefore, the value observed in the Dose Increase Effect Verification Phase was not used to impute a missing data in the Long-term Phase.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

81 participants

Primary outcome timeframe

Baseline and Week 12

Results posted on

2018-06-20

Participant Flow

A total of 81 participants (par.) were randomized, of which 71 participants completed the Dose Increase Effect Verification (DIEV) Phase and 62 participants entered the Long-term Phase and 39 participants completing the Long-term Phase.

This study was comprised of a Screening Phase (4 weeks), DIEV Phase (12 weeks), Down Titration 1 Phase (1 week), Long-term Phase (39 weeks), Down Titration 2 Phase (1 to 2 weeks) and the Follow-up Phase. The first 60 par. who completed the DIEV phase entered into the Long-term phase after a completion of the Down Titration 1 phase.

Participant milestones

Participant milestones
Measure	Ropinirole CR - High Dose Group Participants received ropinirole controlled released (CR) 16 milligrams (mg) administered orally once daily (OD) for 4 weeks in the Screening Phase. After randomization, participants entered the Dose Increase Effect Verification Phase, where ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24 mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. After the completion of the Dose Increase Effect Verification Phase, participants entered the Down Titration Phase for 1 week and selected participants entered the Long-term Phase for 39 weeks.	Ropinirole CR - Maintenance Dose Group Participants received ropinirole CR 16 mg per day administered orally OD for 4 weeks in the Screening phase. After randomization, participants entered the Dose Increase Effect Verification Phase, where ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. After the completion of the Dose Increase Effect Verification Phase, participants entered the Down Titration Phase for 1 week and selected participants entered the Long-term Phase for 39 weeks.
Dose Increase Effect Verification Phase STARTED	61	20
Dose Increase Effect Verification Phase COMPLETED	52	19
Dose Increase Effect Verification Phase NOT COMPLETED	9	1
Long-term Phase STARTED	44	18
Long-term Phase COMPLETED	25	14
Long-term Phase NOT COMPLETED	19	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Ropinirole CR - High Dose Group Participants received ropinirole controlled released (CR) 16 milligrams (mg) administered orally once daily (OD) for 4 weeks in the Screening Phase. After randomization, participants entered the Dose Increase Effect Verification Phase, where ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24 mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. After the completion of the Dose Increase Effect Verification Phase, participants entered the Down Titration Phase for 1 week and selected participants entered the Long-term Phase for 39 weeks.	Ropinirole CR - Maintenance Dose Group Participants received ropinirole CR 16 mg per day administered orally OD for 4 weeks in the Screening phase. After randomization, participants entered the Dose Increase Effect Verification Phase, where ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. After the completion of the Dose Increase Effect Verification Phase, participants entered the Down Titration Phase for 1 week and selected participants entered the Long-term Phase for 39 weeks.
Dose Increase Effect Verification Phase Adverse Event	5	1
Dose Increase Effect Verification Phase Physician Decision	1	0
Dose Increase Effect Verification Phase Withdrawal by Subject	3	0
Long-term Phase Adverse Event	5	1
Long-term Phase Physician Decision	3	0
Long-term Phase Withdrawal by Subject	4	0
Long-term Phase Protocol Violation	1	0
Long-term Phase Protocol-defined Stopping Criteria	1	0
Long-term Phase Study Closed/Terminated	5	3

Baseline Characteristics

A Study to Evaluate the Efficacy of 18 to 24mg/Day Ropinirole Controlled Release (CR) Tablets in Early and Advanced Parkinson's Disease (PD) Patients.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ropinirole CR - High Dose Group n=61 Participants Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.	Ropinirole CR - Maintenance Dose Group n=20 Participants Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.	Total n=81 Participants Total of all reporting groups
Age, Continuous	65.5 Years STANDARD_DEVIATION 8.95 • n=5 Participants	63.3 Years STANDARD_DEVIATION 12.42 • n=7 Participants	65.0 Years STANDARD_DEVIATION 9.88 • n=5 Participants
Sex: Female, Male Female	39 Participants n=5 Participants	11 Participants n=7 Participants	50 Participants n=5 Participants
Sex: Female, Male Male	22 Participants n=5 Participants	9 Participants n=7 Participants	31 Participants n=5 Participants
Race/Ethnicity, Customized Japanese/East Asian Heritage (EAH)/South EAH	61 Participants n=5 Participants	20 Participants n=7 Participants	81 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and Week 12

Population: Full Analysis Set 1 (FAS1) Population: all participants excluding those participants who received no dose of study medication and participants without UPDRS part III total score data after supply of the investigational product.

Outcome measures

Outcome measures
Measure	Ropinirole CR - High Dose Group n=61 Participants Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.	Ropinirole CR - Maintenance Dose Group Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
Mean Change From Baseline (Week 0) in UPDRS Part III Total Score at Week 12 in the CR High-dose Group	-4.8 Scores on a scale Standard Deviation 5.95	—

SECONDARY outcome

Timeframe: Baseline, Weeks, 2, 4, 6, 8 and 12

Outcome measures

Outcome measures
Measure	Ropinirole CR - High Dose Group n=61 Participants Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.	Ropinirole CR - Maintenance Dose Group n=20 Participants Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
Mean Change From Baseline (Week 0) in UPDRS Part III Total Score at the Indicated Visits Week 12	-4.8 Scores on a scale Standard Deviation 5.95	-5.7 Scores on a scale Standard Deviation 5.18
Mean Change From Baseline (Week 0) in UPDRS Part III Total Score at the Indicated Visits Week 2	-2.9 Scores on a scale Standard Deviation 4.41	-2.7 Scores on a scale Standard Deviation 4.27
Mean Change From Baseline (Week 0) in UPDRS Part III Total Score at the Indicated Visits Week 4	-3.8 Scores on a scale Standard Deviation 5.23	-4.4 Scores on a scale Standard Deviation 3.50
Mean Change From Baseline (Week 0) in UPDRS Part III Total Score at the Indicated Visits Week 6	-4.6 Scores on a scale Standard Deviation 5.28	-5.0 Scores on a scale Standard Deviation 5.09
Mean Change From Baseline (Week 0) in UPDRS Part III Total Score at the Indicated Visits Week 8	-5.2 Scores on a scale Standard Deviation 5.46	-4.5 Scores on a scale Standard Deviation 4.94

SECONDARY outcome

Timeframe: Baseline, Weeks, 2, 4, 6, 8 and 12

Population: FAS1 Population

The Japanese UPDRS assesses the status of Parkinson's Disease (PD) participants objectively. Part III assessed motor examination on 27 items. Participants received a score of 0-4 points per item. The maximum total score is 108 points. A higher score indicates more severe PD symptoms. Number of participants achieving a 30% or greater and 20% or greater reduction from Baseline in UPDRS total part III score at Weeks 2, 4, 6, 8, and 12 are presented using LOCF data. In the LOCF data, the last available data was used for the imputation for missing data at a planned visit. The imputation was conducted using the data within only the Dose Increase Effect Verification Phase; therefore, the value observed in the Dose Increase Effect Verification Phase was not used to impute a missing data in the Long-term Phase.

Outcome measures

Outcome measures
Measure	Ropinirole CR - High Dose Group n=61 Participants Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.	Ropinirole CR - Maintenance Dose Group n=20 Participants Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
Number of Participants Achieving a 30% and 20% Reduction From Baseline in the UPDRS Total Part 3 Score at the Indicated Visits in the Dose Increase Effect Verification Phase Week 2, 30% or greater reduction from Baseline	10 Participants	4 Participants
Number of Participants Achieving a 30% and 20% Reduction From Baseline in the UPDRS Total Part 3 Score at the Indicated Visits in the Dose Increase Effect Verification Phase Week 4, 30% or greater reduction from Baseline	17 Participants	5 Participants
Number of Participants Achieving a 30% and 20% Reduction From Baseline in the UPDRS Total Part 3 Score at the Indicated Visits in the Dose Increase Effect Verification Phase Week 6, 30% or greater reduction from Baseline	21 Participants	6 Participants
Number of Participants Achieving a 30% and 20% Reduction From Baseline in the UPDRS Total Part 3 Score at the Indicated Visits in the Dose Increase Effect Verification Phase Week 4, 20% or greater reduction from Baseline	26 Participants	11 Participants
Number of Participants Achieving a 30% and 20% Reduction From Baseline in the UPDRS Total Part 3 Score at the Indicated Visits in the Dose Increase Effect Verification Phase Week 6, 20% or greater reduction from Baseline	30 Participants	10 Participants
Number of Participants Achieving a 30% and 20% Reduction From Baseline in the UPDRS Total Part 3 Score at the Indicated Visits in the Dose Increase Effect Verification Phase Week 8, 30% or greater reduction from Baseline	30 Participants	7 Participants
Number of Participants Achieving a 30% and 20% Reduction From Baseline in the UPDRS Total Part 3 Score at the Indicated Visits in the Dose Increase Effect Verification Phase Week 12, 30% or greater reduction from Baseline	27 Participants	7 Participants
Number of Participants Achieving a 30% and 20% Reduction From Baseline in the UPDRS Total Part 3 Score at the Indicated Visits in the Dose Increase Effect Verification Phase Week 2, 20% or greater reduction from Baseline	16 Participants	5 Participants
Number of Participants Achieving a 30% and 20% Reduction From Baseline in the UPDRS Total Part 3 Score at the Indicated Visits in the Dose Increase Effect Verification Phase Week 8, 20% or greater reduction from Baseline	35 Participants	11 Participants
Number of Participants Achieving a 30% and 20% Reduction From Baseline in the UPDRS Total Part 3 Score at the Indicated Visits in the Dose Increase Effect Verification Phase Week 12, 20% or greater reduction from Baseline	31 Participants	13 Participants

SECONDARY outcome

Timeframe: Baseline, Weeks, 2, 4, 6, 8 and 12

Population: FAS1 Population

The Japanese UPDRS assesses the status of PD participants objectively. Part I evaluated mentation, behavior, and mood on 4 items, response for each item were scored numerically from 0-4. The total score for the 4 items ranged from 0 to 16. A higher score indicates more severe PD symptoms. Change from Baseline was calculated by subtracting the Baseline value from the post Baseline value. Baseline is defined as the value evaluated at Week 0. The analyses for the Dose Increase Effect Verification Phase was performed using the LOCF data. In the LOCF data, the last available data was used for the imputation for missing data at the planned visit.

Outcome measures

Outcome measures
Measure	Ropinirole CR - High Dose Group n=61 Participants Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.	Ropinirole CR - Maintenance Dose Group n=20 Participants Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
Change From Baseline in the Japanese UPDRS Part 1 Total Score at the Indicated Visits in the Dose Increase Effect Verification Phase Week 6	-0.1 Scores on a scale Standard Deviation 0.69	-0.1 Scores on a scale Standard Deviation 0.45
Change From Baseline in the Japanese UPDRS Part 1 Total Score at the Indicated Visits in the Dose Increase Effect Verification Phase Week 8	-0.1 Scores on a scale Standard Deviation 0.68	-0.1 Scores on a scale Standard Deviation 0.45
Change From Baseline in the Japanese UPDRS Part 1 Total Score at the Indicated Visits in the Dose Increase Effect Verification Phase Week 2	-0.0 Scores on a scale Standard Deviation 0.50	-0.1 Scores on a scale Standard Deviation 0.31
Change From Baseline in the Japanese UPDRS Part 1 Total Score at the Indicated Visits in the Dose Increase Effect Verification Phase Week 4	-0.1 Scores on a scale Standard Deviation 0.57	-0.2 Scores on a scale Standard Deviation 0.49
Change From Baseline in the Japanese UPDRS Part 1 Total Score at the Indicated Visits in the Dose Increase Effect Verification Phase Week 12	0.1 Scores on a scale Standard Deviation 0.89	-0.1 Scores on a scale Standard Deviation 0.45

SECONDARY outcome

Timeframe: Baseline, Weeks, 2, 4, 6, 8 and 12

Population: FAS1 Population. Only those participants available at the specified time points were analyzed (represented by n=X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the FAS1 population.

The Japanese UPDRS assesses the status of PD participants objectively. Part 2 evaluated activities of daily living on 13 items, response for each item were scored numerically from 0-4. The total score for the 4 items ranged from 0 to 52. A higher score indicates more severe PD symptoms. Change from Baseline was calculated by subtracting the Baseline value from the post Baseline value. Baseline is defined as the value evaluated at Week 0. The analyses for the Dose Increase Effect Verification Phase was performed using the LOCF data. In the LOCF data, the last available data was used for the imputation for missing data at a planned visit. "Off" state is defined as the state at which PD symptoms are not adequately controlled by the drug. "On" state is defined as the state at which PD symptoms are well controlled by the drug. The score of UPDRS part 2 in off status is rated as '0' (Normal/None), if L-dopa adjunct participants do not have diurnal fluctuations.

Outcome measures

Outcome measures
Measure	Ropinirole CR - High Dose Group n=61 Participants Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.	Ropinirole CR - Maintenance Dose Group n=20 Participants Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Dose Increase Effect Verification Phase Week 2, On status, n=61, 20	-1.0 Scores on a scale Standard Deviation 2.00	-0.2 Scores on a scale Standard Deviation 0.99
Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Dose Increase Effect Verification Phase Week 2, Off status, n=53, 18	-1.0 Scores on a scale Standard Deviation 2.13	-0.3 Scores on a scale Standard Deviation 1.97
Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Dose Increase Effect Verification Phase Week 4, Off status, n=53, 18	-1.3 Scores on a scale Standard Deviation 3.23	-0.4 Scores on a scale Standard Deviation 2.89
Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Dose Increase Effect Verification Phase Week 6, Off status, n=53, 18	-1.7 Scores on a scale Standard Deviation 3.90	-0.8 Scores on a scale Standard Deviation 2.26
Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Dose Increase Effect Verification Phase Week 8, Off status, n=53, 18	-1.4 Scores on a scale Standard Deviation 3.92	-1.3 Scores on a scale Standard Deviation 2.27
Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Dose Increase Effect Verification Phase Week 4, On status, n=61, 20	-1.4 Scores on a scale Standard Deviation 2.60	-0.3 Scores on a scale Standard Deviation 1.63
Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Dose Increase Effect Verification Phase Week 6, On status, n=61, 20	-1.6 Scores on a scale Standard Deviation 3.03	-0.5 Scores on a scale Standard Deviation 2.04
Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Dose Increase Effect Verification Phase Week 8, On status, n=61, 20	-1.4 Scores on a scale Standard Deviation 3.23	-0.2 Scores on a scale Standard Deviation 2.23
Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Dose Increase Effect Verification Phase Week 12, On status, n=61, 20	-1.1 Scores on a scale Standard Deviation 3.61	-0.2 Scores on a scale Standard Deviation 2.64
Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Dose Increase Effect Verification Phase Week 12, Off status, n=53, 18	-1.4 Scores on a scale Standard Deviation 4.25	-1.3 Scores on a scale Standard Deviation 2.52

SECONDARY outcome

Timeframe: Baseline, Weeks, 2, 4, 6, 8 and 12

Population: FAS1 Population

The Japanese UPDRS assessed the status of PD participants objectively. Part 4 evaluated complications on 11 items, response for 4 items were scored numerically from 0-4 and response for other 7 items were Yes/No questions and responses are numerically scored as 0 for "No" and 1 for "Yes". The total score for the 11 items ranged from 0 to 23. A higher score indicates more severe PD symptoms. Change from Baseline was calculated by subtracting the Baseline value from the post Baseline value. Baseline is defined as the value evaluated at Week 0. The analyses for the Dose Increase Effect Verification Phase was performed using the LOCF data. In the LOCF data, the last available data was used for the imputation for missing data at a planned visit.

Outcome measures

Outcome measures
Measure	Ropinirole CR - High Dose Group n=61 Participants Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.	Ropinirole CR - Maintenance Dose Group n=20 Participants Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
Change From Baseline in the Japanese UPDRS Part 4 Total Score at the Indicated Visits in the Dose Increase Effect Verification Phase Week 12	-0.1 Scores on a scale Standard Deviation 1.38	0.1 Scores on a scale Standard Deviation 1.29
Change From Baseline in the Japanese UPDRS Part 4 Total Score at the Indicated Visits in the Dose Increase Effect Verification Phase Week 2	-0.3 Scores on a scale Standard Deviation 1.10	-0.2 Scores on a scale Standard Deviation 1.01
Change From Baseline in the Japanese UPDRS Part 4 Total Score at the Indicated Visits in the Dose Increase Effect Verification Phase Week 4	-0.2 Scores on a scale Standard Deviation 1.24	-0.2 Scores on a scale Standard Deviation 1.39
Change From Baseline in the Japanese UPDRS Part 4 Total Score at the Indicated Visits in the Dose Increase Effect Verification Phase Week 6	-0.2 Scores on a scale Standard Deviation 1.43	-0.3 Scores on a scale Standard Deviation 1.49
Change From Baseline in the Japanese UPDRS Part 4 Total Score at the Indicated Visits in the Dose Increase Effect Verification Phase Week 8	0.0 Scores on a scale Standard Deviation 1.32	0.1 Scores on a scale Standard Deviation 1.28

SECONDARY outcome

Timeframe: Baseline, Weeks, 2, 4, 6, 8 and 12

Population: FAS1 Population. Only those participants available at the specified time points were analyzed.

The Japanese UPDRS assessed the status of PD participants objectively. Part I evaluated mentation, behavior, and mood on 4 items, response for each item were scored numerically from 0-4. The total score for the 4 items ranged from 0 to 16. A higher score indicates more severe PD symptoms. Percent change from Baseline was calculated as Post baseline value minus Baseline value, divided by Baseline value and multiplied by 100. Baseline is defined as the value evaluated at Week 0. The analyses for Dose Increase Effect Verification Phase was performed using the LOCF data. In the LOCF data, the last available data was used for the imputation for missing data at a planned visit.

Outcome measures

Outcome measures
Measure	Ropinirole CR - High Dose Group n=21 Participants Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.	Ropinirole CR - Maintenance Dose Group n=8 Participants Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
Percent Change From Baseline in the Japanese UPDRS Part 1 Total Score at the Indicated Visits in the Dose Increase Effect Verification Phase Week 2	-6.2 Percent change Standard Deviation 40.06	-16.7 Percent change Standard Deviation 35.63
Percent Change From Baseline in the Japanese UPDRS Part 1 Total Score at the Indicated Visits in the Dose Increase Effect Verification Phase Week 4	-14.5 Percent change Standard Deviation 63.87	-41.7 Percent change Standard Deviation 49.60
Percent Change From Baseline in the Japanese UPDRS Part 1 Total Score at the Indicated Visits in the Dose Increase Effect Verification Phase Week 6	-15.2 Percent change Standard Deviation 83.82	-29.2 Percent change Standard Deviation 45.21
Percent Change From Baseline in the Japanese UPDRS Part 1 Total Score at the Indicated Visits in the Dose Increase Effect Verification Phase Week 8	-16.4 Percent change Standard Deviation 82.27	-29.2 Percent change Standard Deviation 45.21
Percent Change From Baseline in the Japanese UPDRS Part 1 Total Score at the Indicated Visits in the Dose Increase Effect Verification Phase Week 12	-7.4 Percent change Standard Deviation 85.84	-29.2 Percent change Standard Deviation 45.21

SECONDARY outcome

Timeframe: Baseline, Weeks, 2, 4, 6, 8 and 12

The Japanese UPDRS assesses the status of PD participants objectively. Part 2 evaluates activities of daily living on 13 items, response for each item were scored numerically from 0-4. The total score for the 4 items ranged from 0 to 52. A higher score indicates more severe PD symptoms. Percent change from Baseline was calculated as Post baseline value minus Baseline value, divided by Baseline value and multiplied by 100. Baseline is defined as the value at Week 0. The analyses for Dose Increase Effect Verification Phase was performed using the LOCF data. In the LOCF data, the last available data was used for the imputation for missing data at a planned visit. "Off" state is defined as the state at which PD symptoms are not adequately controlled by the drug. "On" state is defined as the state at which PD symptoms are well controlled by the drug. The score of UPDRS part 2 in off status is rated as '0' (Normal/None), if L-dopa adjunct participants do not have diurnal fluctuations.

Outcome measures

Outcome measures
Measure	Ropinirole CR - High Dose Group n=61 Participants Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.	Ropinirole CR - Maintenance Dose Group n=20 Participants Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
Percent Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Dose Increase Effect Verification Phase Week 4, On status, n=55, 16	-21.9 Percent change Standard Deviation 43.38	-13.0 Percent change Standard Deviation 39.07
Percent Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Dose Increase Effect Verification Phase Week 2, Off status, n=48, 15	-11.7 Percent change Standard Deviation 26.38	-4.2 Percent change Standard Deviation 13.45
Percent Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Dose Increase Effect Verification Phase Week 2, On status, n=55, 16	-22.3 Percent change Standard Deviation 35.46	-4.6 Percent change Standard Deviation 20.29
Percent Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Dose Increase Effect Verification Phase Week 6, On status, n=55, 16	-21.4 Percent change Standard Deviation 48.64	-12.9 Percent change Standard Deviation 53.71
Percent Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Dose Increase Effect Verification Phase Week 8, On status, n=55, 16	-14.3 Percent change Standard Deviation 75.53	-9.0 Percent change Standard Deviation 59.34
Percent Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Dose Increase Effect Verification Phase Week 12, On status, n=55, 16	-4.7 Percent change Standard Deviation 102.75	-9.3 Percent change Standard Deviation 63.12
Percent Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Dose Increase Effect Verification Phase Week 4, Off status, n=48, 15	-15.0 Percent change Standard Deviation 36.35	-4.4 Percent change Standard Deviation 18.18
Percent Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Dose Increase Effect Verification Phase Week 6, Off status, n=48, 15	-17.0 Percent change Standard Deviation 42.27	-9.7 Percent change Standard Deviation 17.69
Percent Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Dose Increase Effect Verification Phase Week 8, Off status, n=48, 15	-14.7 Percent change Standard Deviation 40.53	-10.9 Percent change Standard Deviation 16.68
Percent Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Dose Increase Effect Verification Phase Week 12, Off status, n=48, 15	-15.2 Percent change Standard Deviation 44.90	-10.1 Percent change Standard Deviation 14.02

SECONDARY outcome

Timeframe: Baseline, Weeks, 2, 4, 6, 8 and 12

Population: FAS1 Population

The Japanese UPDRS assessed the status of PD participants objectively. Part 3 evaluated motor examination on 27 items, response for each items were scored numerically from 0-4. The total score for the 27 items ranged from 0 to 108. A higher score indicates more severe PD symptoms. Percent change from Baseline was calculated as Post baseline value minus Baseline value, divided by Baseline value and multiplied by 100. Baseline is defined as the value evaluated at Week 0. The analyses for Dose Increase Effect Verification Phase was performed using the LOCF data. In the LOCF data, the last available data was used for the imputation for missing data at a planned visit.

Outcome measures

Outcome measures
Measure	Ropinirole CR - High Dose Group n=61 Participants Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.	Ropinirole CR - Maintenance Dose Group n=20 Participants Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
Percent Change From Baseline in the Japanese UPDRS Part 3 Total Score at the Indicated Visits in the Dose Increase Effect Verification Phase Week 12	-23.1 Percent change Standard Deviation 29.88	-27.6 Percent change Standard Deviation 28.37
Percent Change From Baseline in the Japanese UPDRS Part 3 Total Score at the Indicated Visits in the Dose Increase Effect Verification Phase Week 2	-12.0 Percent change Standard Deviation 18.69	-11.8 Percent change Standard Deviation 22.78
Percent Change From Baseline in the Japanese UPDRS Part 3 Total Score at the Indicated Visits in the Dose Increase Effect Verification Phase Week 4	-17.4 Percent change Standard Deviation 23.29	-21.9 Percent change Standard Deviation 18.81
Percent Change From Baseline in the Japanese UPDRS Part 3 Total Score at the Indicated Visits in the Dose Increase Effect Verification Phase Week 6	-21.6 Percent change Standard Deviation 23.96	-22.9 Percent change Standard Deviation 23.74
Percent Change From Baseline in the Japanese UPDRS Part 3 Total Score at the Indicated Visits in the Dose Increase Effect Verification Phase Week 8	-25.5 Percent change Standard Deviation 26.97	-22.9 Percent change Standard Deviation 25.02

SECONDARY outcome

Timeframe: Baseline, Weeks, 2, 4, 6, 8 and 12

Population: FAS1 Population. Only those participants available at the specified time points were analyzed.

The Japanese UPDRS assessed the status of PD participants objectively. Part 4 evaluated complications on 11 items, response for 4 items were scored numerically from 0-4 and response for other 7 items were Yes/No questions and responses are numerically scored as 0 for "No" and 1 for "Yes". The total score for the 11 items ranged from 0 to 23. A higher score indicates more severe PD symptoms. Percent change from Baseline was calculated as Post baseline value minus Baseline value, divided by Baseline value and multiplied by 100. Baseline is defined as the value evaluated at Week 0. The analyses for Dose Increase Effect Verification Phase was performed using the LOCF data. In the LOCF data, the last available data was used for the imputation for missing data at a planned visit.

Outcome measures

Outcome measures
Measure	Ropinirole CR - High Dose Group n=54 Participants Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.	Ropinirole CR - Maintenance Dose Group n=19 Participants Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
Percent Change From Baseline in the Japanese UPDRS Part 4 Total Score at the Indicated Visits in the Dose Increase Effect Verification Phase Week 8	1.4 Percent change Standard Deviation 46.48	3.5 Percent change Standard Deviation 35.18
Percent Change From Baseline in the Japanese UPDRS Part 4 Total Score at the Indicated Visits in the Dose Increase Effect Verification Phase Week 12	-6.6 Percent change Standard Deviation 46.04	9.5 Percent change Standard Deviation 30.44
Percent Change From Baseline in the Japanese UPDRS Part 4 Total Score at the Indicated Visits in the Dose Increase Effect Verification Phase Week 2	-7.9 Percent change Standard Deviation 36.71	-1.9 Percent change Standard Deviation 31.59
Percent Change From Baseline in the Japanese UPDRS Part 4 Total Score at the Indicated Visits in the Dose Increase Effect Verification Phase Week 4	-4.1 Percent change Standard Deviation 41.73	-6.5 Percent change Standard Deviation 35.97
Percent Change From Baseline in the Japanese UPDRS Part 4 Total Score at the Indicated Visits in the Dose Increase Effect Verification Phase Week 6	-7.2 Percent change Standard Deviation 47.39	-4.9 Percent change Standard Deviation 36.92

SECONDARY outcome

Timeframe: Baseline (Week 13), Weeks 17, 21, 25, 37, 49 and 52

Population: FAS2 Population. Only those participants available at the specified time points were analyzed (represented by n=X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the FAS2 population.

The Japanese UPDRS assessed the status of PD participants objectively. Part I evaluated mentation, behavior, and mood on 4 items, response for each item were scored numerically from 0-4. The total score for the 4 items ranged from 0 to 16. A higher score indicates more severe PD symptoms.Change from Baseline was calculated by subtracting the Baseline value from the post Baseline value. Baseline is defined as the value evaluated at Week 13. If the value evaluated at Week 13 was missing, then first observed value post Week 13 was used as Baseline. The analyses performed using the OC data. In the OC data, no imputation was carried for any missing data. Full Analysis Set 2 (FAS2) Population comprised of all participants in the FAS1 and shifted to Long-term Phase, excluding those participants who received no dose of study medication and participants without UPDRS part III total score data after supply of the investigational product.

Outcome measures

Outcome measures
Measure	Ropinirole CR - High Dose Group n=44 Participants Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.	Ropinirole CR - Maintenance Dose Group n=17 Participants Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
Change From Baseline in the Japanese UPDRS Part 1 Total Score at the Indicated Visits in the Long-term Phase Week 49; n=26, 14	0.2 Scores on a scale Standard Deviation 0.51	0.1 Scores on a scale Standard Deviation 0.73
Change From Baseline in the Japanese UPDRS Part 1 Total Score at the Indicated Visits in the Long-term Phase Week 17; n=42,17	0.1 Scores on a scale Standard Deviation 0.45	0.1 Scores on a scale Standard Deviation 0.56
Change From Baseline in the Japanese UPDRS Part 1 Total Score at the Indicated Visits in the Long-term Phase Week 21; n=40, 16	0.2 Scores on a scale Standard Deviation 0.88	-0.2 Scores on a scale Standard Deviation 0.66
Change From Baseline in the Japanese UPDRS Part 1 Total Score at the Indicated Visits in the Long-term Phase Week 25; n=40, 17	0.2 Scores on a scale Standard Deviation 0.86	-0.1 Scores on a scale Standard Deviation 0.83
Change From Baseline in the Japanese UPDRS Part 1 Total Score at the Indicated Visits in the Long-term Phase Week 37; n=33, 17	0.2 Scores on a scale Standard Deviation 1.02	0.1 Scores on a scale Standard Deviation 0.90
Change From Baseline in the Japanese UPDRS Part 1 Total Score at the Indicated Visits in the Long-term Phase Week 52; n=25, 14	0.2 Scores on a scale Standard Deviation 0.58	0.2 Scores on a scale Standard Deviation 0.97

SECONDARY outcome

Timeframe: Baseline (Week 13), Weeks 17, 21, 25, 37, 49 and 52

The Japanese UPDRS assesses the status of PD participants objectively. Part 2 evaluates activities of daily living on 13 items, response for each item were scored numerically from 0-4. The total score for the 4 items ranged from 0 to 52. A higher score indicates more severe PD symptoms.Change from Baseline was calculated by subtracting the Baseline value from the post Baseline value. Baseline is defined as the value at Week 13. If the value at Week 13 was missing, then first observed value post Week 13 was used as Baseline. The analyses performed using the OC data. In the OC data, no imputation was carried for any missing data."Off" state is defined as the state at which PD symptoms are not adequately controlled by the drug. "On" state is defined as the state at which PD symptoms are well controlled by the drug. The score of UPDRS part 2 in off status is rated as '0' (Normal/None), if L-dopa adjunct participants do not have diurnal fluctuations.

Outcome measures

Outcome measures
Measure	Ropinirole CR - High Dose Group n=44 Participants Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.	Ropinirole CR - Maintenance Dose Group n=17 Participants Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Long Term Phase Week 52, On status, n=25, 14	-0.2 Scores on a scale Standard Deviation 2.67	0.1 Scores on a scale Standard Deviation 1.35
Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Long Term Phase Week 37, Off status, n=29, 15	0.9 Scores on a scale Standard Deviation 3.77	0.0 Scores on a scale Standard Deviation 5.01
Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Long Term Phase Week 17, On status, n=42, 17	-0.1 Scores on a scale Standard Deviation 1.52	0.1 Scores on a scale Standard Deviation 0.60
Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Long Term Phase Week 21, On status, n=40, 16	-0.4 Scores on a scale Standard Deviation 1.60	0.0 Scores on a scale Standard Deviation 0.89
Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Long Term Phase Week 25, On status, n=40, 17	-0.2 Scores on a scale Standard Deviation 1.91	-0.1 Scores on a scale Standard Deviation 0.99
Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Long Term Phase Week 37, On status, n=33, 17	0.0 Scores on a scale Standard Deviation 2.32	0.2 Scores on a scale Standard Deviation 1.48
Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Long Term Phase Week 49, On status, n=26, 14	0.0 Scores on a scale Standard Deviation 2.41	0.6 Scores on a scale Standard Deviation 1.70
Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Long Term Phase Week 17, Off status, n=36, 15	-0.4 Scores on a scale Standard Deviation 2.33	-0.5 Scores on a scale Standard Deviation 1.46
Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Long Term Phase Week 21, Off status, n=34, 14	-0.4 Scores on a scale Standard Deviation 2.32	-0.7 Scores on a scale Standard Deviation 1.07
Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Long Term Phase Week 25, Off status, n=34, 15	-0.2 Scores on a scale Standard Deviation 2.27	-1.5 Scores on a scale Standard Deviation 3.14
Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Long Term Phase Week 49, Off status, n=24, 12	0.4 Scores on a scale Standard Deviation 3.11	0.8 Scores on a scale Standard Deviation 4.84
Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Long Term Phase Week 52, Off status, n=23, 12	0.4 Scores on a scale Standard Deviation 2.52	0.8 Scores on a scale Standard Deviation 4.32

SECONDARY outcome

Timeframe: Baseline (Week 13), Weeks 17, 21, 25, 37, 49, 52

The Japanese UPDRS assesses the status of PD participants objectively. Part 3 evaluates motor examination on 27 items, response for each items were scored numerically from 0-4. The total score for the 27 items ranged from 0 to 108. A higher score indicates more severe PD symptoms. Change from Baseline was calculated by subtracting the Baseline value from the post Baseline value. Baseline is defined as the value evaluated at Week 13. If the value evaluated at Week 13 was missing, then first observed value post Week 13 was used as Baseline. The analyses performed using the OC data. In the OC data, no imputation was carried for any missing data.

Outcome measures

Outcome measures
Measure	Ropinirole CR - High Dose Group n=44 Participants Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.	Ropinirole CR - Maintenance Dose Group n=17 Participants Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
Mean Change From Baseline in UPDRS Part 3 Total Score at the Indicated Visits for Long Term Phase Week 37; n=33, 17	-1.9 Scores on a scale Standard Deviation 6.46	1.4 Scores on a scale Standard Deviation 7.65
Mean Change From Baseline in UPDRS Part 3 Total Score at the Indicated Visits for Long Term Phase Week 49; n=26, 14	-2.2 Scores on a scale Standard Deviation 8.66	0.6 Scores on a scale Standard Deviation 7.38
Mean Change From Baseline in UPDRS Part 3 Total Score at the Indicated Visits for Long Term Phase Week 17; n=41, 16	-1.2 Scores on a scale Standard Deviation 3.46	-0.7 Scores on a scale Standard Deviation 5.03
Mean Change From Baseline in UPDRS Part 3 Total Score at the Indicated Visits for Long Term Phase Week 21, n=39, 16	-2.5 Scores on a scale Standard Deviation 5.53	-1.9 Scores on a scale Standard Deviation 4.92
Mean Change From Baseline in UPDRS Part 3 Total Score at the Indicated Visits for Long Term Phase Week 25, n=40, 17	-2.1 Scores on a scale Standard Deviation 5.09	-0.6 Scores on a scale Standard Deviation 4.31
Mean Change From Baseline in UPDRS Part 3 Total Score at the Indicated Visits for Long Term Phase Week 52; n=25, 14	-1.9 Scores on a scale Standard Deviation 6.92	-0.6 Scores on a scale Standard Deviation 5.49

SECONDARY outcome

Timeframe: Baseline (Week 13), Weeks 17, 21, 25, 37, 49 and 52

The Japanese UPDRS assessed the status of PD participants objectively. Part 4 evaluated complications on 11 items, response for 4 items were scored numerically from 0-4 and response for other 7 items were Yes/No questions and responses are numerically scored as 0 for "No" and 1 for "Yes". The total score for the 11 items ranged from 0 to 23. A higher score indicates more severe PD symptoms.Change from Baseline was calculated by subtracting the Baseline value from the post Baseline value. Baseline is defined as the value evaluated at Week 13. If the value evaluated at Week 13 was missing, then first observed value post Week 13 was used as Baseline. The analyses performed using the OC data. In the OC data, no imputation was carried for any missing data.

Outcome measures

Outcome measures
Measure	Ropinirole CR - High Dose Group n=44 Participants Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.	Ropinirole CR - Maintenance Dose Group n=17 Participants Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
Change From Baseline in the Japanese UPDRS Part 4 Total Score at the Indicated Visits in the Long Term Phase Week 17, n=42, 17	0.1 Scores on a scale Standard Deviation 0.97	-0.1 Scores on a scale Standard Deviation 1.03
Change From Baseline in the Japanese UPDRS Part 4 Total Score at the Indicated Visits in the Long Term Phase Week 21, n=40, 16	0.3 Scores on a scale Standard Deviation 1.01	-0.1 Scores on a scale Standard Deviation 0.89
Change From Baseline in the Japanese UPDRS Part 4 Total Score at the Indicated Visits in the Long Term Phase Week 25, n=40, 17	0.4 Scores on a scale Standard Deviation 0.83	0.2 Scores on a scale Standard Deviation 2.24
Change From Baseline in the Japanese UPDRS Part 4 Total Score at the Indicated Visits in the Long Term Phase Week 37; n=33;17	0.5 Scores on a scale Standard Deviation 1.15	1.1 Scores on a scale Standard Deviation 2.80
Change From Baseline in the Japanese UPDRS Part 4 Total Score at the Indicated Visits in the Long Term Phase Week 49; n=26,14	0.9 Scores on a scale Standard Deviation 1.28	1.2 Scores on a scale Standard Deviation 2.72
Change From Baseline in the Japanese UPDRS Part 4 Total Score at the Indicated Visits in the Long Term Phase Week 52; n=25, 14	0.6 Scores on a scale Standard Deviation 1.04	0.8 Scores on a scale Standard Deviation 2.36

SECONDARY outcome

Timeframe: Baseline (Week 13), Weeks 17, 21, 25, 37, 49 and 52

The Japanese UPDRS assessed the status of PD participants objectively. Part I evaluated mentation, behavior, and mood on 4 items, response for each item were scored numerically from 0-4. The total score for the 4 items ranged from 0 to 16. A higher score indicates more severe PD symptoms. Percent change from Baseline was calculated as Post baseline value minus Baseline value, divided by Baseline value and multiplied by 100. Baseline is defined as the value evaluated at Week 13. If the value evaluated at Week 13 was missing, then first observed value post Week 13 was used as Baseline. The analyses performed using the OC data. In the OC data, no imputation was carried for any missing data.

Outcome measures

Outcome measures
Measure	Ropinirole CR - High Dose Group n=44 Participants Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.	Ropinirole CR - Maintenance Dose Group n=17 Participants Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
Percent Change From Baseline in the Japanese UPDRS Part 1 Total Score at the Indicated Visits in the Long Term Phase Week 25, n=14, 7	3.6 Percent change Standard Deviation 48.89	-26.2 Percent change Standard Deviation 60.75
Percent Change From Baseline in the Japanese UPDRS Part 1 Total Score at the Indicated Visits in the Long Term Phase Week 52; n=6, 5	12.5 Percent change Standard Deviation 44.02	5.0 Percent change Standard Deviation 75.83
Percent Change From Baseline in the Japanese UPDRS Part 1 Total Score at the Indicated Visits in the Long Term Phase Week 17, n=15, 7	13.3 Percent change Standard Deviation 36.43	-9.5 Percent change Standard Deviation 71.27
Percent Change From Baseline in the Japanese UPDRS Part 1 Total Score at the Indicated Visits in the Long Term Phase Week 21, n=14, 7	-7.1 Percent change Standard Deviation 28.47	-31.0 Percent change Standard Deviation 53.08
Percent Change From Baseline in the Japanese UPDRS Part 1 Total Score at the Indicated Visits in the Long Term Phase Week 37; n=9, 7	0.0 Percent change Standard Deviation 43.30	-11.9 Percent change Standard Deviation 77.41
Percent Change From Baseline in the Japanese UPDRS Part 1 Total Score at the Indicated Visits in the Long Term Phase Week 49; n=6, 5	20.8 Percent change Standard Deviation 40.05	15.0 Percent change Standard Deviation 85.88

SECONDARY outcome

Timeframe: Baseline (Week 13), Weeks 17, 21, 25, 37, 49 and 52

The Japanese UPDRS assesses the status of PD participants objectively. Part 2 evaluates activities of daily living on 13 items, response for each item were scored numerically from 0-4. The total score for the 4 items ranged from 0 to 52. A higher score indicates more severe PD symptoms. Percent change from Baseline was calculated as Post baseline value minus Baseline value, divided by Baseline value and multiplied by 100. Baseline is defined as the value at Week 13. If the value at Week 13 was missing, then first observed value post Week 13 was used as Baseline. The analyses performed using the OC data. In the OC data, no imputation was carried for any missing data."Off" state is defined as the state at which PD symptoms are not adequately controlled by the drug. "On" state is defined as the state at which PD symptoms are well controlled by the drug. The score of UPDRS part 2 in off status is rated as '0' (Normal/None), if L-dopa adjunct participants do not have diurnal fluctuations.

Outcome measures

Outcome measures
Measure	Ropinirole CR - High Dose Group n=44 Participants Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.	Ropinirole CR - Maintenance Dose Group n=17 Participants Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
Percent Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Long-term Phase Week 25, Off status, n=24, 13	1.4 Percent change Standard Deviation 41.65	-5.2 Percent change Standard Deviation 38.30
Percent Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Long-term Phase Week 37, Off status, n=20, 13	6.1 Percent change Standard Deviation 54.09	6.3 Percent change Standard Deviation 50.27
Percent Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Long-term Phase Week 49, Off status, n=16, 11	1.9 Percent change Standard Deviation 41.71	44.5 Percent change Standard Deviation 96.82
Percent Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Long-term Phase Week 52, Off status, n=15, 11	7.1 Percent change Standard Deviation 39.24	26.2 Percent change Standard Deviation 50.57
Percent Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Long-term Phase Week 17, On status, n=35, 12	2.3 Percent change Standard Deviation 62.37	-5.8 Percent change Standard Deviation 30.29
Percent Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Long-term Phase Week 21, On status, n=33, 11	-0.1 Percent change Standard Deviation 62.87	-7.1 Percent change Standard Deviation 36.34
Percent Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Long-term Phase Week 25, On status, n=33, 12	-1.7 Percent change Standard Deviation 41.50	-0.7 Percent change Standard Deviation 46.77
Percent Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Long-term Phase Week 37, On status, n=26, 12	8.0 Percent change Standard Deviation 64.38	-8.6 Percent change Standard Deviation 34.96
Percent Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Long-term Phase Week 49, On status, n=20, 9	27.8 Percent change Standard Deviation 99.17	1.8 Percent change Standard Deviation 54.21
Percent Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Long-term Phase Week 52, On status, n=19, 9	7.5 Percent change Standard Deviation 93.46	0.7 Percent change Standard Deviation 54.13
Percent Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Long-term Phase Week 17, Off status, n=26, 13	-1.4 Percent change Standard Deviation 29.10	-3.6 Percent change Standard Deviation 14.44
Percent Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Long-term Phase Week 21, Off status, n=24, 12	-4.4 Percent change Standard Deviation 35.76	-6.0 Percent change Standard Deviation 9.09

SECONDARY outcome

Timeframe: Baseline (Week 13), Weeks 17, 21, 25, 37, 49 and 52

The Japanese UPDRS assessed the status of PD participants objectively. Part 3 evaluated motor examination on 27 items, response for each items were scored numerically from 0-4. The total score for the 27 items ranged from 0 to 108. A higher score indicates more severe PD symptoms. Percent change from Baseline was calculated as Post baseline value minus Baseline value, divided by Baseline value and multiplied by 100. Baseline is defined as the value evaluated at Week 13. If the value evaluated at Week 13 was missing, then first observed value post Week 13 was used as Baseline. The analyses performed using the OC data. In the OC data, no imputation was carried for any missing data.

Outcome measures

Outcome measures
Measure	Ropinirole CR - High Dose Group n=44 Participants Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.	Ropinirole CR - Maintenance Dose Group n=17 Participants Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
Percent Change From Baseline in the Japanese UPDRS Part 3 Total Score at the Indicated Visits in the Long Term Phase Week 21, n=39, 16	-10.5 Percent change Standard Deviation 25.83	-6.0 Percent change Standard Deviation 35.72
Percent Change From Baseline in the Japanese UPDRS Part 3 Total Score at the Indicated Visits in the Long Term Phase Week 25, n=40, 17	-10.3 Percent change Standard Deviation 31.99	2.6 Percent change Standard Deviation 36.71
Percent Change From Baseline in the Japanese UPDRS Part 3 Total Score at the Indicated Visits in the Long Term Phase Week 49; n=26, 14	-3.4 Percent change Standard Deviation 46.73	43.2 Percent change Standard Deviation 134.85
Percent Change From Baseline in the Japanese UPDRS Part 3 Total Score at the Indicated Visits in the Long Term Phase Week 17, n=41, 16	-5.4 Percent change Standard Deviation 20.98	6.2 Percent change Standard Deviation 38.25
Percent Change From Baseline in the Japanese UPDRS Part 3 Total Score at the Indicated Visits in the Long Term Phase Week 37; n=33, 17	-6.4 Percent change Standard Deviation 30.91	50.2 Percent change Standard Deviation 148.56
Percent Change From Baseline in the Japanese UPDRS Part 3 Total Score at the Indicated Visits in the Long Term Phase Week 52; n=25, 14	-4.1 Percent change Standard Deviation 44.35	16.2 Percent change Standard Deviation 77.23

SECONDARY outcome

Timeframe: Baseline (Week 13), Weeks 17, 21, 25, 37, 49 and 52

The Japanese UPDRS assesses the status of PD participants objectively. Part 4 evaluates complications on 11 items, response for 4 items were scored numerically from 0-4 and response for other 7 items were Yes/No questions and responses are numerically scored as 0 for "No" and 1 for "Yes". The total score for the 11 items ranged from 0 to 23. A higher score indicates more severe PD symptoms. Percent change from Baseline was calculated as Post baseline value minus Baseline value, divided by Baseline value and multiplied by 100. Baseline is defined as the value evaluated at Week 13. If the value evaluated at Week 13 was missing, then first observed value post Week 13 was used as Baseline. The analyses performed using the OC data. In the OC data, no imputation was carried for any missing data.

Outcome measures

Outcome measures
Measure	Ropinirole CR - High Dose Group n=44 Participants Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.	Ropinirole CR - Maintenance Dose Group n=17 Participants Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
Percent Change From Baseline in the Japanese UPDRS Part 4 Total Score at the Indicated Visits in the Long-term Phase Week 25, n=28, 15	16.4 Percent change Standard Deviation 41.65	18.7 Percent change Standard Deviation 101.42
Percent Change From Baseline in the Japanese UPDRS Part 4 Total Score at the Indicated Visits in the Long-term Phase Week 49, n=18, 13	27.5 Percent change Standard Deviation 34.93	40.0 Percent change Standard Deviation 123.78
Percent Change From Baseline in the Japanese UPDRS Part 4 Total Score at the Indicated Visits in the Long-term Phase Week 17, n=30, 15	13.1 Percent change Standard Deviation 49.42	7.1 Percent change Standard Deviation 43.29
Percent Change From Baseline in the Japanese UPDRS Part 4 Total Score at the Indicated Visits in the Long-term Phase Week 21, n=28, 14	11.3 Percent change Standard Deviation 48.62	6.8 Percent change Standard Deviation 41.68
Percent Change From Baseline in the Japanese UPDRS Part 4 Total Score at the Indicated Visits in the Long-term Phase Week 37, n=23, 15	11.3 Percent change Standard Deviation 38.32	49.5 Percent change Standard Deviation 139.78
Percent Change From Baseline in the Japanese UPDRS Part 4 Total Score at the Indicated Visits in the Long-term Phase Week 52, n=17, 13	23.7 Percent change Standard Deviation 36.32	35.4 Percent change Standard Deviation 104.67

SECONDARY outcome

Timeframe: Baseline, Weeks, 2, 4, 6, 8 and 12

Population: FAS1 Population. Only those participants available at the specified time points were analyzed.

"Off" state is defined as the state at which PD symptoms are not adequately controlled by the drug. Participants were asked to record the duration of their "off " periods and asleep in diary cards every day. Change from Baseline in awake time spent "Off"(actual hours) is calculated as awake time spent "Off" (hours) at the indicated visit minus awake time spent "Off" (hours) at Baseline. Baseline is defined as the value at Week 0. The analyses for Dose Increase Effect Verification Phase was performed using the LOCF data. In the LOCF data, the last available data was used for the imputation for missing data at a planned visit.

Outcome measures

Outcome measures
Measure	Ropinirole CR - High Dose Group n=46 Participants Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.	Ropinirole CR - Maintenance Dose Group n=13 Participants Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
Change From Baseline in the Actual Hours of Awake Time Spent "Off" at the Indicated Visits Only in Participants Who Received L-dopa Adjunct Week 8	-0.08 hours Standard Deviation 2.552	0.77 hours Standard Deviation 2.442
Change From Baseline in the Actual Hours of Awake Time Spent "Off" at the Indicated Visits Only in Participants Who Received L-dopa Adjunct Week 2	0.14 hours Standard Deviation 2.260	0.44 hours Standard Deviation 1.605
Change From Baseline in the Actual Hours of Awake Time Spent "Off" at the Indicated Visits Only in Participants Who Received L-dopa Adjunct Week 4	0.09 hours Standard Deviation 2.308	0.04 hours Standard Deviation 1.817
Change From Baseline in the Actual Hours of Awake Time Spent "Off" at the Indicated Visits Only in Participants Who Received L-dopa Adjunct Week 6	0.01 hours Standard Deviation 2.645	0.37 hours Standard Deviation 2.068
Change From Baseline in the Actual Hours of Awake Time Spent "Off" at the Indicated Visits Only in Participants Who Received L-dopa Adjunct Week 12	-0.27 hours Standard Deviation 2.781	0.81 hours Standard Deviation 1.953

SECONDARY outcome

Timeframe: Baseline, Weeks, 2, 4, 6, 8 and 12

Population: FAS1 Population. Only those participants available at the specified time points were analyzed.

"Off" state is defined as the state at which PD symptoms are not adequately controlled by the drug. Participants were asked to record the duration of their "off " periods and asleep in diary cards every day. Percentage of awake time spent "off" is defined as sum of two days off time (hours) divided by sum of two days awake time (hours) and multiplied by 100. Change from Baseline was calculated by subtracting the Baseline value (percentage of awake time spent "off") from the post Baseline value (percentage of awake time spent "off"). Baseline is defined as the value at Week 0. The analyses for Dose Increase Effect Verification Phase was performed using the LOCF data. In the LOCF data, the last available data was used for the imputation for missing data at a planned visit.

Outcome measures

Outcome measures
Measure	Ropinirole CR - High Dose Group n=46 Participants Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.	Ropinirole CR - Maintenance Dose Group n=13 Participants Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
Change From Baseline in the Percentage of Awake Time Spent "Off" at the Indicated Visits Only in Participants Who Received L-dopa Adjunct Week 2	1.36 percentage of awake time spent off Standard Deviation 13.025	2.39 percentage of awake time spent off Standard Deviation 9.119
Change From Baseline in the Percentage of Awake Time Spent "Off" at the Indicated Visits Only in Participants Who Received L-dopa Adjunct Week 6	-0.09 percentage of awake time spent off Standard Deviation 15.677	2.70 percentage of awake time spent off Standard Deviation 10.518
Change From Baseline in the Percentage of Awake Time Spent "Off" at the Indicated Visits Only in Participants Who Received L-dopa Adjunct Week 8	0.19 percentage of awake time spent off Standard Deviation 16.012	4.65 percentage of awake time spent off Standard Deviation 12.040
Change From Baseline in the Percentage of Awake Time Spent "Off" at the Indicated Visits Only in Participants Who Received L-dopa Adjunct Week 12	-1.24 percentage of awake time spent off Standard Deviation 16.814	4.74 percentage of awake time spent off Standard Deviation 11.214
Change From Baseline in the Percentage of Awake Time Spent "Off" at the Indicated Visits Only in Participants Who Received L-dopa Adjunct Week 4	0.62 percentage of awake time spent off Standard Deviation 13.486	0.48 percentage of awake time spent off Standard Deviation 10.116

SECONDARY outcome

Timeframe: Baseline, Weeks, 2, 4, 6, 8 and 12

"On" state is defined as the state at which PD symptoms are well controlled by the drug. Participants were asked to record the duration of their "off " periods and asleep in diary cards every day. Change from Baseline in awake time spent "On"(actual hours) is calculated as awake time spent "On" (hours) at the indicated visit minus awake time spent "On" (hours) at Baseline. Baseline is defined as the value at Week 0. The analyses for Dose Increase Effect Verification Phase was performed using the LOCF data. In the LOCF data, the last available data was used for the imputation for missing data at a planned visit.

Outcome measures

Outcome measures
Measure	Ropinirole CR - High Dose Group n=53 Participants Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.	Ropinirole CR - Maintenance Dose Group n=18 Participants Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
Change From Baseline in Actual Hours of Awake Time Spent "On" at the Indicated Visits Only in Participants Who Received L-dopa Adjunct Week 2, n=53, 17	-0.39 hours Standard Deviation 2.154	-0.46 hours Standard Deviation 1.635
Change From Baseline in Actual Hours of Awake Time Spent "On" at the Indicated Visits Only in Participants Who Received L-dopa Adjunct Week 4, n=53, 18	-0.12 hours Standard Deviation 2.271	-0.60 hours Standard Deviation 2.180
Change From Baseline in Actual Hours of Awake Time Spent "On" at the Indicated Visits Only in Participants Who Received L-dopa Adjunct Week 6, n=53, 18	-0.01 hours Standard Deviation 2.474	-0.61 hours Standard Deviation 1.676
Change From Baseline in Actual Hours of Awake Time Spent "On" at the Indicated Visits Only in Participants Who Received L-dopa Adjunct Week 8, n=53, 18	-0.11 hours Standard Deviation 2.759	-0.96 hours Standard Deviation 1.554
Change From Baseline in Actual Hours of Awake Time Spent "On" at the Indicated Visits Only in Participants Who Received L-dopa Adjunct Week 12, n=53, 18	0.07 hours Standard Deviation 2.789	-0.79 hours Standard Deviation 1.815

SECONDARY outcome

Timeframe: Baseline, Weeks, 2, 4, 6, 8 and 12

"On" state is defined as the state at which PD symptoms are well controlled by the drug. Participants were asked to record the duration of their "off " periods and asleep in diary cards every day. Change from Baseline in awake time spent "On" without troublesome dyskinesias (actual hours) is calculated as \[awake time spent "On" minus awake time spent "On" with troublesome dyskinesias\] (hours) at visit minus \[awake time spent "On" minus awake time spent "On" with troublesome dyskinesias\] (hours) at Baseline. Baseline is defined as the value at Week 0. The analyses for Dose Increase Effect Verification Phase was performed using the LOCF data. In the LOCF data, the last available data was used for the imputation for missing data at a planned visit.

Outcome measures

Outcome measures
Measure	Ropinirole CR - High Dose Group n=53 Participants Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.	Ropinirole CR - Maintenance Dose Group n=18 Participants Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
Change From Baseline in Actual Hours of Awake Time Spent "On"Without Troublesome Dyskinesias at the Indicated Visits Only in Participants Who Received L-dopa Adjunct Week 4, n=53, 18	-0.14 hours Standard Deviation 2.359	-0.71 hours Standard Deviation 1.745
Change From Baseline in Actual Hours of Awake Time Spent "On"Without Troublesome Dyskinesias at the Indicated Visits Only in Participants Who Received L-dopa Adjunct Week 2, n=53, 17	-0.40 hours Standard Deviation 2.276	-0.59 hours Standard Deviation 1.400
Change From Baseline in Actual Hours of Awake Time Spent "On"Without Troublesome Dyskinesias at the Indicated Visits Only in Participants Who Received L-dopa Adjunct Week 6, n=53, 18	-0.06 hours Standard Deviation 2.566	-0.63 hours Standard Deviation 1.476
Change From Baseline in Actual Hours of Awake Time Spent "On"Without Troublesome Dyskinesias at the Indicated Visits Only in Participants Who Received L-dopa Adjunct Week 8, n=53, 18	-0.05 hours Standard Deviation 2.896	-1.01 hours Standard Deviation 1.549
Change From Baseline in Actual Hours of Awake Time Spent "On"Without Troublesome Dyskinesias at the Indicated Visits Only in Participants Who Received L-dopa Adjunct Week 12, n=53, 18	0.11 hours Standard Deviation 2.968	-0.74 hours Standard Deviation 1.733

SECONDARY outcome

Timeframe: Week 12

Population: FAS1 Population. Only those participants available at the specified time points were analyzed.

The CGI global improvement scale allows the investigator to rate the participant's total improvement since the beginning of treatment (Baseline). Scores on the scale range from 1 to 7 (1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, and 7=very much worse). Participants with a CGI global improvement score of \<=2 (representing much improved or very much improved) were considered to be moderate improvement (responder). The analyses performed using the OC data. In the OC data, no imputation was carried for any missing data.

Outcome measures

Outcome measures
Measure	Ropinirole CR - High Dose Group n=52 Participants Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.	Ropinirole CR - Maintenance Dose Group n=19 Participants Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
Number of Participants With an Improvement (Responder) in the Clinical Global Impression (CGI) Global Improvement Scale at Week 12	19 Participants	6 Participants

SECONDARY outcome

Timeframe: From the start of the study medication (Week 0) until Week 52

Population: Safety Population 2 (SP2) compraised of all participants who included in SP1 (receive at least one dose of medication in Dose Increase Effect Verification Phase) and shifted to Long-term Phase and received at least one dose of medication in Long-term Phase.

Outcome measures

Outcome measures
Measure	Ropinirole CR - High Dose Group n=44 Participants Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.	Ropinirole CR - Maintenance Dose Group n=18 Participants Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
Number of Participants Remaining in the Study	25 Participants	14 Participants

SECONDARY outcome

Timeframe: Baseline (Week 13), Weeks 17, 21, 25, 37, 49, 52

The Japanese UPDRS assesses the status of Parkinson's Disease (PD) participants objectively. Part III assessed motor examination on 27 items. Participants received a score of 0-4 points per item. The maximum total score is 108 points. A higher score indicates more severe PD symptoms. Number of participants achieving a 30% or greater and 20% or greater reduction from Baseline in UPDRS total part III score at Weeks 17, 21, 25, 37, 49 and 52,are presented using OC data. Change from Baseline was calculated by subtracting the Baseline value from the post Baseline value. Baseline is defined as the value evaluated at Week 13. If the value evaluated at Week 13 was missing, then first observed value post Week 13 was used as Baseline. The OC (observed Case) dataset was defined as the dataset consisting of observed data without any missing data imputation.

Outcome measures

Outcome measures
Measure	Ropinirole CR - High Dose Group n=44 Participants Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.	Ropinirole CR - Maintenance Dose Group n=17 Participants Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
Number of Participants Achieving a 30% and 20% Reduction From Baseline in the UPDRS Total Part 3 Score at the Indicated Visits in Long Term Phase. Week 17, >=30% reduction from Baseline; n=41,16	5 Participants	2 Participants
Number of Participants Achieving a 30% and 20% Reduction From Baseline in the UPDRS Total Part 3 Score at the Indicated Visits in Long Term Phase. Week 25, >=30% reduction from Baseline; n=40, 17	9 Participants	3 Participants
Number of Participants Achieving a 30% and 20% Reduction From Baseline in the UPDRS Total Part 3 Score at the Indicated Visits in Long Term Phase. Week 37, >=30% reduction from Baseline; n=33,17	8 Participants	3 Participants
Number of Participants Achieving a 30% and 20% Reduction From Baseline in the UPDRS Total Part 3 Score at the Indicated Visits in Long Term Phase. Week 21, >=20% reduction from Baseline; n=39,16	15 Participants	3 Participants
Number of Participants Achieving a 30% and 20% Reduction From Baseline in the UPDRS Total Part 3 Score at the Indicated Visits in Long Term Phase. Week 25, >=20% reduction from Baseline; n=40, 17	16 Participants	3 Participants
Number of Participants Achieving a 30% and 20% Reduction From Baseline in the UPDRS Total Part 3 Score at the Indicated Visits in Long Term Phase. Week 21, >=30% reduction from Baseline; n=39,16	8 Participants	3 Participants
Number of Participants Achieving a 30% and 20% Reduction From Baseline in the UPDRS Total Part 3 Score at the Indicated Visits in Long Term Phase. Week 49, >=30% reduction from Baseline; n=26, 14	9 Participants	1 Participants
Number of Participants Achieving a 30% and 20% Reduction From Baseline in the UPDRS Total Part 3 Score at the Indicated Visits in Long Term Phase. Week 52, >=30% reduction from Baseline; n=25, 14	6 Participants	2 Participants
Number of Participants Achieving a 30% and 20% Reduction From Baseline in the UPDRS Total Part 3 Score at the Indicated Visits in Long Term Phase. Week 17, >=20% reduction from Baseline; n=41,16	8 Participants	2 Participants
Number of Participants Achieving a 30% and 20% Reduction From Baseline in the UPDRS Total Part 3 Score at the Indicated Visits in Long Term Phase. Week 37, >=20% reduction from Baseline; n=33,17	14 Participants	3 Participants
Number of Participants Achieving a 30% and 20% Reduction From Baseline in the UPDRS Total Part 3 Score at the Indicated Visits in Long Term Phase. Week 49, >=20% reduction from Baseline; n=26, 14	13 Participants	3 Participants
Number of Participants Achieving a 30% and 20% Reduction From Baseline in the UPDRS Total Part 3 Score at the Indicated Visits in Long Term Phase. Week 52, >=20% reduction from Baseline; n=25, 14	12 Participants	4 Participants

SECONDARY outcome

Timeframe: Baseline (Week 13), Weeks 17, 21, 25, 37, 49 and 52

Population: FAS2 Population who received L-dopa adjunct in Long term phase. Only those participants available at the specified time points were analyzed (represented by n=X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the FAS2 population.

"Off" state is defined as the state at which PD symptoms are not adequately controlled by the drug. Participants were asked to record the duration of their "off " periods and asleep in diary cards every day. Change from Baseline was calculated by subtracting the Baseline value (actual hours of awake time spent "off") from the week 17, 21, 25, 37, 49 and 52 value (proportion of awake time spent "off"). Baseline is defined as the value at Week 13. If the value evaluated at week 13 was missing then first observed value post week 13 was used as a Baseline.The analyses for long term phase was performed using the OC data. In the OC data, no imputation was carried for any missing data

Outcome measures

Outcome measures
Measure	Ropinirole CR - High Dose Group n=38 Participants Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.	Ropinirole CR - Maintenance Dose Group n=15 Participants Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
Change From Baseline in the Actual Hours of Awake Time Spent "Off" at the Indicated Visits Only in Participants Who Received L-dopa Adjunct in Long Term Phase Week 37, n=20, 13	0.01 hours Standard Deviation 2.999	-0.46 hours Standard Deviation 2.252
Change From Baseline in the Actual Hours of Awake Time Spent "Off" at the Indicated Visits Only in Participants Who Received L-dopa Adjunct in Long Term Phase Week 17, n=26, 13	-0.63 hours Standard Deviation 2.600	-0.50 hours Standard Deviation 1.829
Change From Baseline in the Actual Hours of Awake Time Spent "Off" at the Indicated Visits Only in Participants Who Received L-dopa Adjunct in Long Term Phase Week 21, n=24, 12	-0.40 hours Standard Deviation 1.892	-0.65 hours Standard Deviation 1.428
Change From Baseline in the Actual Hours of Awake Time Spent "Off" at the Indicated Visits Only in Participants Who Received L-dopa Adjunct in Long Term Phase Week 25, n=24, 13	0.04 hours Standard Deviation 1.442	-0.52 hours Standard Deviation 1.325
Change From Baseline in the Actual Hours of Awake Time Spent "Off" at the Indicated Visits Only in Participants Who Received L-dopa Adjunct in Long Term Phase Week 49, n=18, 11	-0.24 hours Standard Deviation 1.945	0.91 hours Standard Deviation 3.117
Change From Baseline in the Actual Hours of Awake Time Spent "Off" at the Indicated Visits Only in Participants Who Received L-dopa Adjunct in Long Term Phase Week 52, n=15, 11	-0.62 hours Standard Deviation 1.797	0.45 hours Standard Deviation 2.255

SECONDARY outcome

Timeframe: Baseline (Week 13), Weeks 17, 21, 25, 37, 49 and 52

"Off" state is defined as the state at which PD symptoms are not adequately controlled by the drug. Participants were asked to record the duration of their "off " periods and asleep in diary cards every day. Percentage of awake time spent "off" is defined as sum of two days off time (hours) divided by sum of two days awake time (hours) and multiplied by 100. Change from Baseline was calculated by subtracting the Baseline value (percentage of awake time spent "off") from week 17, 21, 25, 37, 49 and 52 value (percentage of awake time spent "off"). Baseline is defined as the value at Week 13, If the value evaluated at week 13 was missing then first observed value post week 13 was used as a Baseline. The analyses for Long term phase was performed using the OC data. In the OC data, no imputation was carried for any missing data.

Outcome measures

Outcome measures
Measure	Ropinirole CR - High Dose Group n=38 Participants Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.	Ropinirole CR - Maintenance Dose Group n=15 Participants Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
Change From Baseline in the Percentage of Awake Time Spent "Off" at the Indicated Visits Only in Participants Who Received L-dopa Adjunct in Long Term Phase Week 25, n=24, 13	0.49 percentage of awake time spent off Standard Deviation 8.123	-3.95 percentage of awake time spent off Standard Deviation 10.677
Change From Baseline in the Percentage of Awake Time Spent "Off" at the Indicated Visits Only in Participants Who Received L-dopa Adjunct in Long Term Phase Week 17, n=26, 13	-4.16 percentage of awake time spent off Standard Deviation 15.734	-4.41 percentage of awake time spent off Standard Deviation 16.606
Change From Baseline in the Percentage of Awake Time Spent "Off" at the Indicated Visits Only in Participants Who Received L-dopa Adjunct in Long Term Phase Week 21, n=24, 12	-2.59 percentage of awake time spent off Standard Deviation 10.682	-5.39 percentage of awake time spent off Standard Deviation 13.102
Change From Baseline in the Percentage of Awake Time Spent "Off" at the Indicated Visits Only in Participants Who Received L-dopa Adjunct in Long Term Phase Week 37, n=20, 13	-0.99 percentage of awake time spent off Standard Deviation 15.204	-4.56 percentage of awake time spent off Standard Deviation 20.134
Change From Baseline in the Percentage of Awake Time Spent "Off" at the Indicated Visits Only in Participants Who Received L-dopa Adjunct in Long Term Phase Week 49, n=18, 11	-1.33 percentage of awake time spent off Standard Deviation 11.509	2.93 percentage of awake time spent off Standard Deviation 19.464
Change From Baseline in the Percentage of Awake Time Spent "Off" at the Indicated Visits Only in Participants Who Received L-dopa Adjunct in Long Term Phase Week 52, n=15, 11	-3.62 percentage of awake time spent off Standard Deviation 9.925	1.24 percentage of awake time spent off Standard Deviation 13.957

SECONDARY outcome

Timeframe: Baseline (Week 13), Weeks 17, 21, 25, 37, 49 and 52

"On" state is defined as the state at which PD symptoms are well controlled by the drug. Participants were asked to record the duration of their "off " periods and asleep in diary cards every day. Change from Baseline in awake time spent "On"(actual hours) is calculated as awake time spent "On" (hours) at the week 17, 21, 25, 37, 49 and 52 value minus awake time spent "On" (hours) at Baseline. Baseline is defined as the value at Week 13. If the value evaluated at week 13 was missing then first observed value post week 13 was used as a Baseline. The analyses for Long term phase was performed using the OC data. The OC (observed Case) dataset was defined as the dataset consisting of observed data without any missing data imputation.

Outcome measures

Outcome measures
Measure	Ropinirole CR - High Dose Group n=38 Participants Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.	Ropinirole CR - Maintenance Dose Group n=15 Participants Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
Change From Baseline in Actual Hours of Awake Time Spent "On" at the Indicated Visits Only in Participants Who Received L-dopa Adjunct in Long Term Phase Week 21, n=34, 14	0.43 hours Standard Deviation 1.585	0.73 hours Standard Deviation 2.006
Change From Baseline in Actual Hours of Awake Time Spent "On" at the Indicated Visits Only in Participants Who Received L-dopa Adjunct in Long Term Phase Week 17, n=36, 15	0.56 hours Standard Deviation 2.472	0.57 hours Standard Deviation 2.376
Change From Baseline in Actual Hours of Awake Time Spent "On" at the Indicated Visits Only in Participants Who Received L-dopa Adjunct in Long Term Phase Week 25, n=34, 15	-0.04 hours Standard Deviation 1.434	0.23 hours Standard Deviation 1.896
Change From Baseline in Actual Hours of Awake Time Spent "On" at the Indicated Visits Only in Participants Who Received L-dopa Adjunct in Long Term Phase Week 37, n=29, 15	0.26 hours Standard Deviation 2.188	0.37 hours Standard Deviation 3.266
Change From Baseline in Actual Hours of Awake Time Spent "On" at the Indicated Visits Only in Participants Who Received L-dopa Adjunct in Long Term Phase Week 49, n=26, 12	-0.19 hours Standard Deviation 1.764	-0.56 hours Standard Deviation 3.163
Change From Baseline in Actual Hours of Awake Time Spent "On" at the Indicated Visits Only in Participants Who Received L-dopa Adjunct in Long Term Phase Week 52, n=23, 12	0.36 hours Standard Deviation 1.539	-0.56 hours Standard Deviation 2.358

SECONDARY outcome

Timeframe: Baseline (Week 13), Weeks 17, 21, 25, 37, 49 and 52

"On" state is defined as the state at which PD symptoms are well controlled by the drug. Participants were asked to record the duration of their "on " periods and asleep in diary cards every day. Change from Baseline in awake time spent "On" without troublesome dyskinesias (actual hours) is calculated as \[awake time spent "On" minus awake time spent "On" with troublesome dyskinesias\] (hours) at visit minus \[awake time spent "On" minus awake time spent "On" with troublesome dyskinesias\] (hours) at Baseline. Baseline is defined as the value at Week 13. If the value evaluated at week 13 was missing then first observed value post week 13 was used as a Baseline. The analyses for Long term phase was performed using the OC data. In the OC data, no imputation was carried for any missing data

Outcome measures

Outcome measures
Measure	Ropinirole CR - High Dose Group n=38 Participants Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.	Ropinirole CR - Maintenance Dose Group n=15 Participants Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
Change From Baseline in Actual Hours of Awake Time Spent "On" Without Troublesome Dyskinesias at the Indicated Visits Only in Participants Who Received L-dopa Adjunct in Long Term Phase Week 49, n=26, 12	-0.50 hours Standard Deviation 1.877	0.04 hours Standard Deviation 2.720
Change From Baseline in Actual Hours of Awake Time Spent "On" Without Troublesome Dyskinesias at the Indicated Visits Only in Participants Who Received L-dopa Adjunct in Long Term Phase Week 52, n=23, 12	0.08 hours Standard Deviation 1.378	-0.21 hours Standard Deviation 2.886
Change From Baseline in Actual Hours of Awake Time Spent "On" Without Troublesome Dyskinesias at the Indicated Visits Only in Participants Who Received L-dopa Adjunct in Long Term Phase Week 17, n=36, 15	0.24 hours Standard Deviation 2.245	0.60 hours Standard Deviation 2.347
Change From Baseline in Actual Hours of Awake Time Spent "On" Without Troublesome Dyskinesias at the Indicated Visits Only in Participants Who Received L-dopa Adjunct in Long Term Phase Week 21, n=34, 14	0.21 hours Standard Deviation 1.850	1.23 hours Standard Deviation 2.403
Change From Baseline in Actual Hours of Awake Time Spent "On" Without Troublesome Dyskinesias at the Indicated Visits Only in Participants Who Received L-dopa Adjunct in Long Term Phase Week 25, n=34, 15	-0.15 hours Standard Deviation 1.341	0.25 hours Standard Deviation 2.615
Change From Baseline in Actual Hours of Awake Time Spent "On" Without Troublesome Dyskinesias at the Indicated Visits Only in Participants Who Received L-dopa Adjunct in Long Term Phase Week 37, n=29, 15	-0.09 hours Standard Deviation 2.247	1.02 hours Standard Deviation 3.447

SECONDARY outcome

Timeframe: Baseline (Week 13), Weeks 17, 21, 25, 37, 49 and 52

"On" state is defined as the state at which PD symptoms are well controlled by the drug. Participants were asked to record the duration of their "on " periods and asleep in diary cards every day. Percentage of awake time spent "on" is defined as sum of two days on time (hours) divided by sum of two days awake time (hours) and multiplified by 100. Change from Baseline was calculated by subtracting the Baseline value (percentage of awake time spent "on") from week 17, 21, 25, 37, 49 and 52 value (percentage of awake time spent "on"). Baseline is defined as the value at Week 13. If the value evaluated at week 13 was missing the first observed value post week 13 was used as a Baseline.The analyses for Long term phase was performed using the OC data. In the OC data, no imputation was carried for any missing data.

Outcome measures

Outcome measures
Measure	Ropinirole CR - High Dose Group n=38 Participants Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.	Ropinirole CR - Maintenance Dose Group n=15 Participants Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
Change From Baseline in Percentage of Awake Time Spent "On" at the Indicated Visits Only in Participants Who Received L-dopa Adjunct in Long Term Phase Week 17, n=36, 15	2.81 percentage of awake time spent on Standard Deviation 13.529	3.82 percentage of awake time spent on Standard Deviation 15.452
Change From Baseline in Percentage of Awake Time Spent "On" at the Indicated Visits Only in Participants Who Received L-dopa Adjunct in Long Term Phase Week 25, n=34, 15	-1.02 percentage of awake time spent on Standard Deviation 7.813	3.42 percentage of awake time spent on Standard Deviation 9.982
Change From Baseline in Percentage of Awake Time Spent "On" at the Indicated Visits Only in Participants Who Received L-dopa Adjunct in Long Term Phase Week 37, n=29, 15	0.13 percentage of awake time spent on Standard Deviation 12.766	3.27 percentage of awake time spent on Standard Deviation 19.048
Change From Baseline in Percentage of Awake Time Spent "On" at the Indicated Visits Only in Participants Who Received L-dopa Adjunct in Long Term Phase Week 21, n=34, 14	1.20 percentage of awake time spent on Standard Deviation 9.841	4.62 percentage of awake time spent on Standard Deviation 12.211
Change From Baseline in Percentage of Awake Time Spent "On" at the Indicated Visits Only in Participants Who Received L-dopa Adjunct in Long Term Phase Week 49, n=26, 12	-0.23 percentage of awake time spent on Standard Deviation 10.389	-2.68 percentage of awake time spent on Standard Deviation 18.578
Change From Baseline in Percentage of Awake Time Spent "On" at the Indicated Visits Only in Participants Who Received L-dopa Adjunct in Long Term Phase Week 52, n=23, 12	1.80 percentage of awake time spent on Standard Deviation 8.706	-1.14 percentage of awake time spent on Standard Deviation 13.313

SECONDARY outcome

Timeframe: Baseline (Week 13), Weeks 17, 21, 25, 37, 49 and 52

"On" state is defined as the state at which PD symptoms are well controlled by the drug. Par. were asked to record the duration of their "on " periods and asleep in diary cards every day. Percentage of awake time spent "On" without troublesome dyskinesias is defined as sum of two days on time without troublesome dyskinesias \["On" time minus "On" time with troublesome dyskinesias\] (hours) divided by sum of two days awake time (hours) and multiplified by 100. Change from Baseline was calculated by subtracting the Baseline value (percentage of awake time spent "On" without troublesome dyskinesias) from week 17, 21, 25, 37, 49 and 52 value (percentage of awake time spent "On" without troublesome dyskinesias). Baseline is defined as the value at Week 13. If the value evaluated at week 13 was missing the first observed value post week 13 was used as a Baseline.The analyses for Long term phase was performed using the OC data. In the OC data, no imputation was carried for any missing data.

Outcome measures

Outcome measures
Measure	Ropinirole CR - High Dose Group n=38 Participants Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.	Ropinirole CR - Maintenance Dose Group n=15 Participants Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
Change From Baseline in Percentage of Awake Time Spent "On" Without Troublesome Dyskinesias at the Indicated Visits Only in Participants Who Received L-dopa Adjunct in Long Term Phase Week 37, n=29, 15	-1.71 percentage of awake time spent on Standard Deviation 13.698	6.93 percentage of awake time spent on Standard Deviation 19.472
Change From Baseline in Percentage of Awake Time Spent "On" Without Troublesome Dyskinesias at the Indicated Visits Only in Participants Who Received L-dopa Adjunct in Long Term Phase Week 17, n=36, 15	0.70 percentage of awake time spent on Standard Deviation 11.655	4.04 percentage of awake time spent on Standard Deviation 15.472
Change From Baseline in Percentage of Awake Time Spent "On" Without Troublesome Dyskinesias at the Indicated Visits Only in Participants Who Received L-dopa Adjunct in Long Term Phase Week 21, n=34, 14	-0.16 percentage of awake time spent on Standard Deviation 11.730	7.31 percentage of awake time spent on Standard Deviation 13.780
Change From Baseline in Percentage of Awake Time Spent "On" Without Troublesome Dyskinesias at the Indicated Visits Only in Participants Who Received L-dopa Adjunct in Long Term Phase Week 25, n=34, 15	-1.70 percentage of awake time spent on Standard Deviation 7.765	3.10 percentage of awake time spent on Standard Deviation 15.036
Change From Baseline in Percentage of Awake Time Spent "On" Without Troublesome Dyskinesias at the Indicated Visits Only in Participants Who Received L-dopa Adjunct in Long Term Phase Week 49, n=26, 12	-2.00 percentage of awake time spent on Standard Deviation 11.835	0.45 percentage of awake time spent on Standard Deviation 15.958
Change From Baseline in Percentage of Awake Time Spent "On" Without Troublesome Dyskinesias at the Indicated Visits Only in Participants Who Received L-dopa Adjunct in Long Term Phase Week 52, n=23, 12	-0.05 percentage of awake time spent on Standard Deviation 7.521	0.53 percentage of awake time spent on Standard Deviation 14.966

Adverse Events

Ropinirole CR - High Dose Group

Serious events: 2 serious events

Other events: 13 other events

Deaths: 0 deaths

Ropinirole CR - Maintenance Group

Serious events: 4 serious events

Other events: 11 other events

Deaths: 0 deaths

Ropinirole CR - High Dose Group: Long Term Phase

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Ropinirole CR - Maintenance Group: Long Term Phase

Serious events: 1 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Ropinirole CR - High Dose Group n=61 participants at risk Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.	Ropinirole CR - Maintenance Group n=20 participants at risk Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.	Ropinirole CR - High Dose Group: Long Term Phase n=44 participants at risk Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.	Ropinirole CR - Maintenance Group: Long Term Phase n=18 participants at risk Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
Cardiac disorders Atrial fibrillation	0.00% 0/61 • Serious adverse events (SAEs) and non-SAEs were collected from the start of study treatment (Week 0) until Week 52. SAEs and non-SAEs were collected in participants of the SP1 Population, comprised of all participants who had received at least one dose of medication in the Dose Increase Effect Verification Phase.	5.0% 1/20 • Serious adverse events (SAEs) and non-SAEs were collected from the start of study treatment (Week 0) until Week 52. SAEs and non-SAEs were collected in participants of the SP1 Population, comprised of all participants who had received at least one dose of medication in the Dose Increase Effect Verification Phase.	0.00% 0/44 • Serious adverse events (SAEs) and non-SAEs were collected from the start of study treatment (Week 0) until Week 52. SAEs and non-SAEs were collected in participants of the SP1 Population, comprised of all participants who had received at least one dose of medication in the Dose Increase Effect Verification Phase.	0.00% 0/18 • Serious adverse events (SAEs) and non-SAEs were collected from the start of study treatment (Week 0) until Week 52. SAEs and non-SAEs were collected in participants of the SP1 Population, comprised of all participants who had received at least one dose of medication in the Dose Increase Effect Verification Phase.
Cardiac disorders Myocardial infarction	1.6% 1/61 • Serious adverse events (SAEs) and non-SAEs were collected from the start of study treatment (Week 0) until Week 52. SAEs and non-SAEs were collected in participants of the SP1 Population, comprised of all participants who had received at least one dose of medication in the Dose Increase Effect Verification Phase.	0.00% 0/20 • Serious adverse events (SAEs) and non-SAEs were collected from the start of study treatment (Week 0) until Week 52. SAEs and non-SAEs were collected in participants of the SP1 Population, comprised of all participants who had received at least one dose of medication in the Dose Increase Effect Verification Phase.	0.00% 0/44 • Serious adverse events (SAEs) and non-SAEs were collected from the start of study treatment (Week 0) until Week 52. SAEs and non-SAEs were collected in participants of the SP1 Population, comprised of all participants who had received at least one dose of medication in the Dose Increase Effect Verification Phase.	0.00% 0/18 • Serious adverse events (SAEs) and non-SAEs were collected from the start of study treatment (Week 0) until Week 52. SAEs and non-SAEs were collected in participants of the SP1 Population, comprised of all participants who had received at least one dose of medication in the Dose Increase Effect Verification Phase.
Cardiac disorders Pericarditis	1.6% 1/61 • Serious adverse events (SAEs) and non-SAEs were collected from the start of study treatment (Week 0) until Week 52. SAEs and non-SAEs were collected in participants of the SP1 Population, comprised of all participants who had received at least one dose of medication in the Dose Increase Effect Verification Phase.	0.00% 0/20 • Serious adverse events (SAEs) and non-SAEs were collected from the start of study treatment (Week 0) until Week 52. SAEs and non-SAEs were collected in participants of the SP1 Population, comprised of all participants who had received at least one dose of medication in the Dose Increase Effect Verification Phase.	0.00% 0/44 • Serious adverse events (SAEs) and non-SAEs were collected from the start of study treatment (Week 0) until Week 52. SAEs and non-SAEs were collected in participants of the SP1 Population, comprised of all participants who had received at least one dose of medication in the Dose Increase Effect Verification Phase.	0.00% 0/18 • Serious adverse events (SAEs) and non-SAEs were collected from the start of study treatment (Week 0) until Week 52. SAEs and non-SAEs were collected in participants of the SP1 Population, comprised of all participants who had received at least one dose of medication in the Dose Increase Effect Verification Phase.
Gastrointestinal disorders Inguinal hernia	0.00% 0/61 • Serious adverse events (SAEs) and non-SAEs were collected from the start of study treatment (Week 0) until Week 52. SAEs and non-SAEs were collected in participants of the SP1 Population, comprised of all participants who had received at least one dose of medication in the Dose Increase Effect Verification Phase.	5.0% 1/20 • Serious adverse events (SAEs) and non-SAEs were collected from the start of study treatment (Week 0) until Week 52. SAEs and non-SAEs were collected in participants of the SP1 Population, comprised of all participants who had received at least one dose of medication in the Dose Increase Effect Verification Phase.	0.00% 0/44 • Serious adverse events (SAEs) and non-SAEs were collected from the start of study treatment (Week 0) until Week 52. SAEs and non-SAEs were collected in participants of the SP1 Population, comprised of all participants who had received at least one dose of medication in the Dose Increase Effect Verification Phase.	0.00% 0/18 • Serious adverse events (SAEs) and non-SAEs were collected from the start of study treatment (Week 0) until Week 52. SAEs and non-SAEs were collected in participants of the SP1 Population, comprised of all participants who had received at least one dose of medication in the Dose Increase Effect Verification Phase.
Injury, poisoning and procedural complications Fractured sacrum	0.00% 0/61 • Serious adverse events (SAEs) and non-SAEs were collected from the start of study treatment (Week 0) until Week 52. SAEs and non-SAEs were collected in participants of the SP1 Population, comprised of all participants who had received at least one dose of medication in the Dose Increase Effect Verification Phase.	5.0% 1/20 • Serious adverse events (SAEs) and non-SAEs were collected from the start of study treatment (Week 0) until Week 52. SAEs and non-SAEs were collected in participants of the SP1 Population, comprised of all participants who had received at least one dose of medication in the Dose Increase Effect Verification Phase.	0.00% 0/44 • Serious adverse events (SAEs) and non-SAEs were collected from the start of study treatment (Week 0) until Week 52. SAEs and non-SAEs were collected in participants of the SP1 Population, comprised of all participants who had received at least one dose of medication in the Dose Increase Effect Verification Phase.	0.00% 0/18 • Serious adverse events (SAEs) and non-SAEs were collected from the start of study treatment (Week 0) until Week 52. SAEs and non-SAEs were collected in participants of the SP1 Population, comprised of all participants who had received at least one dose of medication in the Dose Increase Effect Verification Phase.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian cancer	1.6% 1/61 • Serious adverse events (SAEs) and non-SAEs were collected from the start of study treatment (Week 0) until Week 52. SAEs and non-SAEs were collected in participants of the SP1 Population, comprised of all participants who had received at least one dose of medication in the Dose Increase Effect Verification Phase.	0.00% 0/20 • Serious adverse events (SAEs) and non-SAEs were collected from the start of study treatment (Week 0) until Week 52. SAEs and non-SAEs were collected in participants of the SP1 Population, comprised of all participants who had received at least one dose of medication in the Dose Increase Effect Verification Phase.	0.00% 0/44 • Serious adverse events (SAEs) and non-SAEs were collected from the start of study treatment (Week 0) until Week 52. SAEs and non-SAEs were collected in participants of the SP1 Population, comprised of all participants who had received at least one dose of medication in the Dose Increase Effect Verification Phase.	0.00% 0/18 • Serious adverse events (SAEs) and non-SAEs were collected from the start of study treatment (Week 0) until Week 52. SAEs and non-SAEs were collected in participants of the SP1 Population, comprised of all participants who had received at least one dose of medication in the Dose Increase Effect Verification Phase.
Nervous system disorders Cerebral infarction	0.00% 0/61 • Serious adverse events (SAEs) and non-SAEs were collected from the start of study treatment (Week 0) until Week 52. SAEs and non-SAEs were collected in participants of the SP1 Population, comprised of all participants who had received at least one dose of medication in the Dose Increase Effect Verification Phase.	5.0% 1/20 • Serious adverse events (SAEs) and non-SAEs were collected from the start of study treatment (Week 0) until Week 52. SAEs and non-SAEs were collected in participants of the SP1 Population, comprised of all participants who had received at least one dose of medication in the Dose Increase Effect Verification Phase.	0.00% 0/44 • Serious adverse events (SAEs) and non-SAEs were collected from the start of study treatment (Week 0) until Week 52. SAEs and non-SAEs were collected in participants of the SP1 Population, comprised of all participants who had received at least one dose of medication in the Dose Increase Effect Verification Phase.	0.00% 0/18 • Serious adverse events (SAEs) and non-SAEs were collected from the start of study treatment (Week 0) until Week 52. SAEs and non-SAEs were collected in participants of the SP1 Population, comprised of all participants who had received at least one dose of medication in the Dose Increase Effect Verification Phase.
Reproductive system and breast disorders Uterine prolapse	0.00% 0/61 • Serious adverse events (SAEs) and non-SAEs were collected from the start of study treatment (Week 0) until Week 52. SAEs and non-SAEs were collected in participants of the SP1 Population, comprised of all participants who had received at least one dose of medication in the Dose Increase Effect Verification Phase.	5.0% 1/20 • Serious adverse events (SAEs) and non-SAEs were collected from the start of study treatment (Week 0) until Week 52. SAEs and non-SAEs were collected in participants of the SP1 Population, comprised of all participants who had received at least one dose of medication in the Dose Increase Effect Verification Phase.	0.00% 0/44 • Serious adverse events (SAEs) and non-SAEs were collected from the start of study treatment (Week 0) until Week 52. SAEs and non-SAEs were collected in participants of the SP1 Population, comprised of all participants who had received at least one dose of medication in the Dose Increase Effect Verification Phase.	5.6% 1/18 • Serious adverse events (SAEs) and non-SAEs were collected from the start of study treatment (Week 0) until Week 52. SAEs and non-SAEs were collected in participants of the SP1 Population, comprised of all participants who had received at least one dose of medication in the Dose Increase Effect Verification Phase.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric cancer	0.00% 0/61 • Serious adverse events (SAEs) and non-SAEs were collected from the start of study treatment (Week 0) until Week 52. SAEs and non-SAEs were collected in participants of the SP1 Population, comprised of all participants who had received at least one dose of medication in the Dose Increase Effect Verification Phase.	0.00% 0/20 • Serious adverse events (SAEs) and non-SAEs were collected from the start of study treatment (Week 0) until Week 52. SAEs and non-SAEs were collected in participants of the SP1 Population, comprised of all participants who had received at least one dose of medication in the Dose Increase Effect Verification Phase.	0.00% 0/44 • Serious adverse events (SAEs) and non-SAEs were collected from the start of study treatment (Week 0) until Week 52. SAEs and non-SAEs were collected in participants of the SP1 Population, comprised of all participants who had received at least one dose of medication in the Dose Increase Effect Verification Phase.	5.6% 1/18 • Serious adverse events (SAEs) and non-SAEs were collected from the start of study treatment (Week 0) until Week 52. SAEs and non-SAEs were collected in participants of the SP1 Population, comprised of all participants who had received at least one dose of medication in the Dose Increase Effect Verification Phase.

Other adverse events

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
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