Trial Outcomes & Findings for Safety and Efficacy of Pasireotide Long Acting Release (LAR) vs. Octreotide LAR in Patients With Active Acromegaly (NCT NCT00600886)

NCT ID: NCT00600886

Last Updated: 2017-07-02

Results Overview

Percentage of participants with a reduction of mean GH levels to \<2.5μg/L (based on a 5-point 2-hour profile) and normalization of sex- and age-adjusted IGF-1. Post surgery = patients with prior surgery but no previous medical treatment for acromegaly De novo = patients with de novo disease who refused pituitary surgery or for whom pituitary surgery was contraindicated.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 358 participants
• Primary outcome timeframe: 12 months
• Results posted on: 2017-07-02

Participant Flow

Participant milestones

Measure	Pasireotide LAR Patients in this arm received Pasireotide LAR 40 mg im depot injection, blinded, once every 28 days (± 2 days) for 12 months. Dose could be down- or up-titrated to 20 or 60 mg, respectively. Patients who responded to Pasireotide LAR (i.e. the randomized treatment) at the end of the core (Month 12), continued Pasireotide LAR treatment in the extension. Patients who did not respond to Pasireotide LAR at the end of the core (Month 12) were allowed to switch to receive Octreotide LAR in the extension.	Octreotide LAR Patients in this arm received Octreotide LAR 20 mg im depot injection, blinded, once every 28 days (± 2 days) for 12 months. Dose could be down- or up-titrated to 10 or 30 mg, respectively. Patients who responded to Octreotide LAR (i.e. the randomized treatment) at the end of the core (Month 12) continued Octreotide LAR treatment in the extension (up to 2 years of treatment). Patients who did not respond to Octreotide LAR at the end of the core (Month 12) were allowed to switch to receive Pasireotide LAR in the extension.
Core Phase - Full Analysis Set (FAS) STARTED	176	182
Core Phase - Full Analysis Set (FAS) Did Not Enter Extension	29	29
Core Phase - Full Analysis Set (FAS) Entered Extension, Crossed Over	38	81
Core Phase - Full Analysis Set (FAS) Entered Ext Continued Same Treatment	74	46
Core Phase - Full Analysis Set (FAS) COMPLETED	141	156
Core Phase - Full Analysis Set (FAS) NOT COMPLETED	35	26
Extension - Same Treatment (FAS) STARTED	74	46
Extension - Same Treatment (FAS) Completed Study at Month 26	0	31
Extension - Same Treatment (FAS) Completed Study After Month 26	28	4
Extension - Same Treatment (FAS) Discontinued After Month 26	23	1
Extension - Same Treatment (FAS) Discontinued Between M12 and M26	23	10
Extension - Same Treatment (FAS) COMPLETED	28	35
Extension - Same Treatment (FAS) NOT COMPLETED	46	11
Extension - After Crossover (CAS) STARTED	81	38
Extension - After Crossover (CAS) Completed Study at Month 26	0	25
Extension - After Crossover (CAS) Completed After Month 26	19	0
Extension - After Crossover (CAS) Discontinued Between M12 and M26	31	13
Extension - After Crossover (CAS) Discontinued After M26	31	0
Extension - After Crossover (CAS) COMPLETED	19	25
Extension - After Crossover (CAS) NOT COMPLETED	62	13

Reasons for withdrawal

Measure	Pasireotide LAR Patients in this arm received Pasireotide LAR 40 mg im depot injection, blinded, once every 28 days (± 2 days) for 12 months. Dose could be down- or up-titrated to 20 or 60 mg, respectively. Patients who responded to Pasireotide LAR (i.e. the randomized treatment) at the end of the core (Month 12), continued Pasireotide LAR treatment in the extension. Patients who did not respond to Pasireotide LAR at the end of the core (Month 12) were allowed to switch to receive Octreotide LAR in the extension.	Octreotide LAR Patients in this arm received Octreotide LAR 20 mg im depot injection, blinded, once every 28 days (± 2 days) for 12 months. Dose could be down- or up-titrated to 10 or 30 mg, respectively. Patients who responded to Octreotide LAR (i.e. the randomized treatment) at the end of the core (Month 12) continued Octreotide LAR treatment in the extension (up to 2 years of treatment). Patients who did not respond to Octreotide LAR at the end of the core (Month 12) were allowed to switch to receive Pasireotide LAR in the extension.
Core Phase - Full Analysis Set (FAS) Adverse Event	14	6
Core Phase - Full Analysis Set (FAS) Protocol Violation	7	8
Core Phase - Full Analysis Set (FAS) Lack of Efficacy	5	8
Core Phase - Full Analysis Set (FAS) Withdrawal by Subject	5	3
Core Phase - Full Analysis Set (FAS) Administrative Problems	2	0
Core Phase - Full Analysis Set (FAS) Abnormal laboratory value(s)	1	0
Core Phase - Full Analysis Set (FAS) Lost to Follow-up	1	0
Core Phase - Full Analysis Set (FAS) Death	0	1
Extension - Same Treatment (FAS) Withdrawal by Subject	16	2
Extension - Same Treatment (FAS) Lack of Efficacy	3	3
Extension - Same Treatment (FAS) Administrative Problems	9	3
Extension - Same Treatment (FAS) Lost to Follow-up	3	1
Extension - Same Treatment (FAS) Adverse Event	4	1
Extension - Same Treatment (FAS) Abnormal Lab Value (s)	4	0
Extension - Same Treatment (FAS) Death	1	1
Extension - Same Treatment (FAS) Condition no longer requires study drug	6	0
Extension - After Crossover (CAS) Adverse Event	19	1
Extension - After Crossover (CAS) Withdrawal by Subject	19	4
Extension - After Crossover (CAS) Lack of Efficacy	13	4
Extension - After Crossover (CAS) Administrative Problems	4	4
Extension - After Crossover (CAS) Subject no longer requires study drug	3	0
Extension - After Crossover (CAS) Abnormal Lab Value (s)	3	0
Extension - After Crossover (CAS) Death	1	0

Baseline Characteristics

Safety and Efficacy of Pasireotide Long Acting Release (LAR) vs. Octreotide LAR in Patients With Active Acromegaly

Baseline characteristics by cohort

Measure	Pasireotide LAR n=176 Participants Patients in this arm received Pasireotide LAR 40 mg im depot injection, blinded, once every 28 days (± 2 days) for 12 months. Dose could be down- or up-titrated to 20 or 60 mg, respectively. Patients who responded to Pasireotide LAR (i.e. the randomized treatment) at the end of the core (Month 12), continued Pasireotide LAR treatment in the extension. Patients who did not respond to Pasireotide LAR at the end of the core (Month 12) were allowed to switch to receive Octreotide LAR in the extension.	Octreotide LAR n=182 Participants Patients in this arm received Octreotide LAR 20 mg im depot injection, blinded, once every 28 days (± 2 days) for 12 months. Dose could be down- or up-titrated to 10 or 30 mg, respectively. Patients who responded to Octreotide LAR (i.e. the randomized treatment) at the end of the core (Month 12) continued Octreotide LAR treatment in the extension (up to 2 years of treatment). Patients who did not respond to Octreotide LAR at the end of the core (Month 12) were allowed to switch to receive Pasireotide LAR in the extension.	Total n=358 Participants Total of all reporting groups
Age, Continuous	45.1 Years STANDARD_DEVIATION 12.37 • n=93 Participants	45.6 Years STANDARD_DEVIATION 12.97 • n=4 Participants	45.4 Years STANDARD_DEVIATION 12.67 • n=27 Participants
Age, Customized <65 Years	168 Participants n=93 Participants	167 Participants n=4 Participants	335 Participants n=27 Participants
Age, Customized >=65 years	8 Participants n=93 Participants	15 Participants n=4 Participants	23 Participants n=27 Participants
Sex: Female, Male Female	91 Participants n=93 Participants	95 Participants n=4 Participants	186 Participants n=27 Participants
Sex: Female, Male Male	85 Participants n=93 Participants	87 Participants n=4 Participants	172 Participants n=27 Participants

PRIMARY outcome

Timeframe: 12 months

Population: Full Analysis Set: All patients (Pts) who were randomized into the study. Pts were analyzed according to the treatment they were assigned to at randomization. Missing mean GH and/or IGF-1 levels at M12 were imputed using data obtained at or after M6 by the last observation carried forward method; otherwise, Pts were considered as non-responders.

Percentage of participants with a reduction of mean GH levels to <2.5μg/L (based on a 5-point 2-hour profile) and normalization of sex- and age-adjusted IGF-1.

Post surgery = patients with prior surgery but no previous medical treatment for acromegaly De novo = patients with de novo disease who refused pituitary surgery or for whom pituitary surgery was contraindicated.

Outcome measures

Measure	Pasireotide LAR (Core) n=176 Participants Includes data from the 12-month blinded core phase for patients randomized to receive Pasireotide LAR.	Octreotide LAR (Core) n=182 Participants Includes data from the 12-month blinded core phase for patients randomized to receive Octreotide LAR.	Pasireotide LAR 60mg Patients in this arm received Pasireotide LAR 60 mg injection prior to PK sample collection.
Percentage of Participants With a Reduction of Mean GH Level to <2.5 μg/L and the Normalization of IGF-1 Overall	31.3 Percentage of Participants Interval 24.5 to 38.7	19.2 Percentage of Participants Interval 13.8 to 25.7	—
Percentage of Participants With a Reduction of Mean GH Level to <2.5 μg/L and the Normalization of IGF-1 Post Surgery	39.4 Percentage of Participants Interval 28.0 to 51.7	21.8 Percentage of Participants Interval 13.2 to 32.6	—
Percentage of Participants With a Reduction of Mean GH Level to <2.5 μg/L and the Normalization of IGF-1 De novo	25.7 Percentage of Participants Interval 17.7 to 35.2	17.3 Percentage of Participants Interval 10.6 to 26.0	—

SECONDARY outcome

Timeframe: 12 Months

Population: FAS: All patients (Pts) who were randomized into the study. Pts were analyzed according to the treatment they were assigned to at randomization. Missing mean GH levels at Month 12 were imputed using data obtained at or after Month 6 by the LOCF (last observation carried forward) method; otherwise, Pts were considered as non-responders.

Percentage of participants with a reduction of mean GH levels to < 2.5μg/L (based on a 5-point 2-hour profile).

Post surgery = patients with prior surgery but no previous medical treatment for acromegaly De novo = patients with de novo disease who refused pituitary surgery or for whom pituitary surgery was contraindicated.

Outcome measures

Measure	Pasireotide LAR (Core) n=176 Participants Includes data from the 12-month blinded core phase for patients randomized to receive Pasireotide LAR.	Octreotide LAR (Core) n=182 Participants Includes data from the 12-month blinded core phase for patients randomized to receive Octreotide LAR.	Pasireotide LAR 60mg Patients in this arm received Pasireotide LAR 60 mg injection prior to PK sample collection.
Percentage of Participants With a Reduction of Mean GH Level to < 2.5μg/L Overall	48.3 Percentage of participants Interval 40.7 to 55.9	51.6 Percentage of participants Interval 44.1 to 59.1	—
Percentage of Participants With a Reduction of Mean GH Level to < 2.5μg/L Post surgery	52.1 Percentage of participants Interval 39.9 to 64.1	51.3 Percentage of participants Interval 39.7 to 62.8	—
Percentage of Participants With a Reduction of Mean GH Level to < 2.5μg/L De novo	45.7 Percentage of participants Interval 36.0 to 55.7	51.9 Percentage of participants Interval 41.9 to 61.8	—

SECONDARY outcome

Timeframe: Baseline, 12 Months

Population: Full Analysis Set (FAS): All patients who were randomized into the study. Patients were analyzed according to the treatment they were assigned to at randomization.

Absolute and percentage change from baseline in tumor volume (assessed by pituitary MRI) Post surgery = patients with prior surgery but no previous medical treatment for acromegaly De novo = patients with de novo disease who refused pituitary surgery or for whom pituitary surgery was contraindicated.

Outcome measures

Measure	Pasireotide LAR (Core) n=176 Participants Includes data from the 12-month blinded core phase for patients randomized to receive Pasireotide LAR.	Octreotide LAR (Core) n=182 Participants Includes data from the 12-month blinded core phase for patients randomized to receive Octreotide LAR.	Pasireotide LAR 60mg Patients in this arm received Pasireotide LAR 60 mg injection prior to PK sample collection.
Change From Baseline in Tumor Volume at 12 Months Overall absolute change at month 12	-987.1 mm^3 Standard Deviation 2448.14	-801.2 mm^3 Standard Deviation 1676.62	—
Change From Baseline in Tumor Volume at 12 Months Post surgery abs. change at month 12	-873.7 mm^3 Standard Deviation 1282.06	-713.8 mm^3 Standard Deviation 1708.20	—
Change From Baseline in Tumor Volume at 12 Months De novo absolute change at month 12	-1051.9 mm^3 Standard Deviation 2919.18	-867.1 mm^3 Standard Deviation 1661.24	—
Change From Baseline in Tumor Volume at 12 Months Overall at baseline	2420.7 mm^3 Standard Deviation 4159.21	2259.2 mm^3 Standard Deviation 3390.20	—
Change From Baseline in Tumor Volume at 12 Months Overall % change at month 12	-39.7 mm^3 Standard Deviation 21.83	-38.0 mm^3 Standard Deviation 24.47	—
Change From Baseline in Tumor Volume at 12 Months Post surgery at baseline	2185.2 mm^3 Standard Deviation 2861.09	2196.5 mm^3 Standard Deviation 3922.08	—
Change From Baseline in Tumor Volume at 12 Months Post surgery % change at month 12	-39.5 mm^3 Standard Deviation 20.60	-39.0 mm^3 Standard Deviation 23.81	—
Change From Baseline in Tumor Volume at 12 Months De novo at baseline	2592.4 mm^3 Standard Deviation 4901.99	2308.1 mm^3 Standard Deviation 2930.84	—
Change From Baseline in Tumor Volume at 12 Months De novo % change at month 12	-39.9 mm^3 Standard Deviation 22.65	-37.2 mm^3 Standard Deviation 25.07	—

SECONDARY outcome

Timeframe: 12 Months

Population: Full Analysis Set: All patients (Pts) who were randomized into the study. Pts were analyzed according to the treatment they were assigned to at randomization. Missing IGF-1 levels at Month 12 were imputed using data obtained at or after Month 6 by the LOCF (last observation carried forward) method; otherwise, Pts were considered as nonresponders.

Percentage of participants with normalization of sex- and age-adjusted IGF-1. Post surgery = patients with prior surgery but no previous medical treatment for acromegaly De novo = patients with de novo disease who refused pituitary surgery or for whom pituitary surgery was contraindicated.

Outcome measures

Measure	Pasireotide LAR (Core) n=176 Participants Includes data from the 12-month blinded core phase for patients randomized to receive Pasireotide LAR.	Octreotide LAR (Core) n=182 Participants Includes data from the 12-month blinded core phase for patients randomized to receive Octreotide LAR.	Pasireotide LAR 60mg Patients in this arm received Pasireotide LAR 60 mg injection prior to PK sample collection.
Percentage of Participants With Normalization of IGF-1 Overall	38.6 Percentage of participants Interval 31.4 to 46.3	23.6 Percentage of participants Interval 17.7 to 30.5	—
Percentage of Participants With Normalization of IGF-1 Post surgery	50.7 Percentage of participants Interval 38.6 to 62.8	26.9 Percentage of participants Interval 17.5 to 38.2	—
Percentage of Participants With Normalization of IGF-1 De novo	30.5 Percentage of participants Interval 21.9 to 40.2	21.2 Percentage of participants Interval 13.8 to 30.3	—

SECONDARY outcome

Timeframe: Months 3, 6, 9, 12, 16, 19, 22, 25

Population: Full Analysis Set: All patients who were randomized into the study.

Percentage of participants with a reduction of mean GH levels to < 2.5μg/L (based on a 5-point 2-hour profile) and normalization of sex- and age-adjusted IGF-1.

Denominator for time points up to Month 12 is the Full Analysis Set (FAS). Denominator for time points after Month 12 excludes patients who completed the core and did not enter the extension. Patients who discontinued were considered non-responders for the time points after discontinuation, patients who crossed over were considered non-responders for all time points after crossover. Analysis was based on data up to crossover (i.e., included data from both blinded core & ext. phase up to 26 Months for patients who continued the same treatment in the extension. For patients who switched to the other treatment, only data collected before crossover was included.)

Outcome measures

Measure	Pasireotide LAR (Core) n=176 Participants Includes data from the 12-month blinded core phase for patients randomized to receive Pasireotide LAR.	Octreotide LAR (Core) n=182 Participants Includes data from the 12-month blinded core phase for patients randomized to receive Octreotide LAR.	Pasireotide LAR 60mg Patients in this arm received Pasireotide LAR 60 mg injection prior to PK sample collection.
Percentage of Participants With a Reduction of Mean GH Level to < 2.5μg/L and Normalization of IGF-1 Month 16	25.2 Percentage of participants Interval 18.4 to 33.0	12.4 Percentage of participants Interval 7.6 to 18.7	—
Percentage of Participants With a Reduction of Mean GH Level to < 2.5μg/L and Normalization of IGF-1 Month 3	30.1 Percentage of participants Interval 23.4 to 37.5	21.4 Percentage of participants Interval 15.7 to 28.1	—
Percentage of Participants With a Reduction of Mean GH Level to < 2.5μg/L and Normalization of IGF-1 Month 6	30.1 Percentage of participants Interval 23.4 to 37.5	19.8 Percentage of participants Interval 14.3 to 26.3	—
Percentage of Participants With a Reduction of Mean GH Level to < 2.5μg/L and Normalization of IGF-1 Month 9	27.8 Percentage of participants Interval 21.4 to 35.1	23.1 Percentage of participants Interval 17.2 to 29.9	—
Percentage of Participants With a Reduction of Mean GH Level to < 2.5μg/L and Normalization of IGF-1 Month 12	29.0 Percentage of participants Interval 22.4 to 36.3	17.6 Percentage of participants Interval 12.3 to 23.9	—
Percentage of Participants With a Reduction of Mean GH Level to < 2.5μg/L and Normalization of IGF-1 Month 19	23.1 Percentage of participants Interval 16.6 to 30.8	13.7 Percentage of participants Interval 8.7 to 20.2	—
Percentage of Participants With a Reduction of Mean GH Level to < 2.5μg/L and Normalization of IGF-1 Month 22	25.2 Percentage of participants Interval 18.4 to 33.0	16.3 Percentage of participants Interval 10.9 to 23.2	—
Percentage of Participants With a Reduction of Mean GH Level to < 2.5μg/L and Normalization of IGF-1 Month 25	24.5 Percentage of participants Interval 17.8 to 32.3	13.7 Percentage of participants Interval 8.7 to 20.2	—

SECONDARY outcome

Timeframe: Baseline, Months 3, 6, 9, 12, 16, 19, 22, 25

Population: Full Analysis Set: All patients who were randomized into the study.

Mean GH levels (based on a 5-point profile over 2 hours). Analysis was based on data up to crossover (i.e., included data from both blinded core and extension phase up to 26 Months for patients who continued the same treatment in the extension. For patients who switched to the other treatment, only data collected before crossover was included).

Outcome measures

Measure	Pasireotide LAR (Core) n=176 Participants Includes data from the 12-month blinded core phase for patients randomized to receive Pasireotide LAR.	Octreotide LAR (Core) n=182 Participants Includes data from the 12-month blinded core phase for patients randomized to receive Octreotide LAR.	Pasireotide LAR 60mg Patients in this arm received Pasireotide LAR 60 mg injection prior to PK sample collection.
Summary of Mean GH Values Baseline	21.9 μg/L Standard Deviation 32.14	18.8 μg/L Standard Deviation 25.95	—
Summary of Mean GH Values Month 3	6.3 μg/L Standard Deviation 12.54	5.8 μg/L Standard Deviation 12.87	—
Summary of Mean GH Values Month 6	5.6 μg/L Standard Deviation 11.47	5.2 μg/L Standard Deviation 10.99	—
Summary of Mean GH Values Month 9	4.9 μg/L Standard Deviation 9.62	4.3 μg/L Standard Deviation 9.70	—
Summary of Mean GH Values Month 12	4.6 μg/L Standard Deviation 9.51	4.5 μg/L Standard Deviation 11.34	—
Summary of Mean GH Values Month 16	2.3 μg/L Standard Deviation 5.64	1.4 μg/L Standard Deviation 1.49	—
Summary of Mean GH Values Month 19	2.1 μg/L Standard Deviation 5.68	1.5 μg/L Standard Deviation 1.68	—
Summary of Mean GH Values Month 22	2.1 μg/L Standard Deviation 6.15	1.4 μg/L Standard Deviation 1.43	—
Summary of Mean GH Values Month 25	2.0 μg/L Standard Deviation 5.02	1.2 μg/L Standard Deviation 1.11	—

SECONDARY outcome

Timeframe: Up to 26 months

Population: Full Analysis Set: All patients who were randomized into the study.

Time to first response for patients achieving a reduction of mean GH level to < 2.5 μg/L and normalization of IGF-1. Analysis was based on data up to crossover (i.e., included data from both blinded core and extension phase up to 26 Months for patients who continued the same treatment in the extension. For patients who switched to the other treatment, only data collected before crossover was included).

Outcome measures

Measure	Pasireotide LAR (Core) n=176 Participants Includes data from the 12-month blinded core phase for patients randomized to receive Pasireotide LAR.	Octreotide LAR (Core) n=182 Participants Includes data from the 12-month blinded core phase for patients randomized to receive Octreotide LAR.	Pasireotide LAR 60mg Patients in this arm received Pasireotide LAR 60 mg injection prior to PK sample collection.
Time to First Response for Patients Achieving a Reduction of Mean GH Level to < 2.5 μg/L and Normalization of IGF-1 (No. of Responders: Pasireotite LAR = 81, Octreotide LAR = 63) )	12.6 Weeks Interval 12.3 to 13.0	12.4 Weeks Interval 12.3 to 13.7	—

SECONDARY outcome

Timeframe: Baseline, Months 12, 25

Population: Full Analysis Set: All patients who were randomized into the study.

Severity scores of acromegaly symptoms (Headache, Fatigue, Perspiration, Paresthesias, Osteoarthralgia). Symptoms were scored from 0 (no symptom) to 4 (very severe). Analysis was based on data up to crossover (i.e., included data from both blinded core and extension phase up to 26 Months for patients who continued the same treatment in the extension. For patients who switched to the other treatment, only data collected before crossover was included).

Outcome measures

Measure	Pasireotide LAR (Core) n=176 Participants Includes data from the 12-month blinded core phase for patients randomized to receive Pasireotide LAR.	Octreotide LAR (Core) n=182 Participants Includes data from the 12-month blinded core phase for patients randomized to receive Octreotide LAR.	Pasireotide LAR 60mg Patients in this arm received Pasireotide LAR 60 mg injection prior to PK sample collection.
Severity Scores of Acromegaly Symptoms Headache - Baseline	0.9 scores on a scale Standard Deviation 1.05	1.0 scores on a scale Standard Deviation 1.14	—
Severity Scores of Acromegaly Symptoms Paresthesia - Baseline	0.7 scores on a scale Standard Deviation 1.00	0.8 scores on a scale Standard Deviation 1.15	—
Severity Scores of Acromegaly Symptoms Perspiration - M12	0.4 scores on a scale Standard Deviation 0.81	0.5 scores on a scale Standard Deviation 0.91	—
Severity Scores of Acromegaly Symptoms Paresthesia - M12	0.3 scores on a scale Standard Deviation 0.63	0.4 scores on a scale Standard Deviation 0.72	—
Severity Scores of Acromegaly Symptoms Osteoarthraliga - M12	0.5 scores on a scale Standard Deviation 0.80	0.7 scores on a scale Standard Deviation 1.00	—
Severity Scores of Acromegaly Symptoms Paresthesia - M25	0.2 scores on a scale Standard Deviation 0.49	0.4 scores on a scale Standard Deviation 0.67	—
Severity Scores of Acromegaly Symptoms Osteoarthraliga - M25	0.4 scores on a scale Standard Deviation 0.79	0.8 scores on a scale Standard Deviation 1.07	—
Severity Scores of Acromegaly Symptoms Fatigue - Baseline	1.2 scores on a scale Standard Deviation 1.13	1.4 scores on a scale Standard Deviation 1.23	—
Severity Scores of Acromegaly Symptoms Perspiration - Baseline	1.1 scores on a scale Standard Deviation 1.21	1.3 scores on a scale Standard Deviation 1.31	—
Severity Scores of Acromegaly Symptoms Osteoarthraliga - Baseline	1.0 scores on a scale Standard Deviation 1.05	1.3 scores on a scale Standard Deviation 1.26	—
Severity Scores of Acromegaly Symptoms Headache - M12	0.5 scores on a scale Standard Deviation 0.77	0.6 scores on a scale Standard Deviation 0.79	—
Severity Scores of Acromegaly Symptoms Fatigue - M12	0.8 scores on a scale Standard Deviation 0.95	0.7 scores on a scale Standard Deviation 0.99	—
Severity Scores of Acromegaly Symptoms Headache - M25	0.4 scores on a scale Standard Deviation 0.61	0.6 scores on a scale Standard Deviation 0.77	—
Severity Scores of Acromegaly Symptoms Fatigue - M25	0.5 scores on a scale Standard Deviation 0.71	0.7 scores on a scale Standard Deviation 0.89	—
Severity Scores of Acromegaly Symptoms Perspiration - M25	0.4 scores on a scale Standard Deviation 0.72	0.4 scores on a scale Standard Deviation 0.67	—

SECONDARY outcome

Timeframe: Baseline, Months 12, 25

Population: Full Analysis Set: All patients who were randomized into the study.

Ring size (based on jeweler's finger gauge). Analysis was based on data up to crossover (i.e., included data from both blinded core and extension phase up to 26 Months for patients who continued the same treatment in the extension. For patients who switched to the other treatment, only data collected before crossover was included).

Outcome measures

Measure	Pasireotide LAR (Core) n=176 Participants Includes data from the 12-month blinded core phase for patients randomized to receive Pasireotide LAR.	Octreotide LAR (Core) n=182 Participants Includes data from the 12-month blinded core phase for patients randomized to receive Octreotide LAR.	Pasireotide LAR 60mg Patients in this arm received Pasireotide LAR 60 mg injection prior to PK sample collection.
Ring Size Baseline left hand (LH) 4th digit	11.6 ring zize Standard Deviation 2.00	11.8 ring zize Standard Deviation 1.97	—
Ring Size Baseline left hand 5th digit	11.7 ring zize Standard Deviation 2.82	12.4 ring zize Standard Deviation 2.88	—
Ring Size M12 LH 4th digit	10.6 ring zize Standard Deviation 2.05	11.1 ring zize Standard Deviation 1.95	—
Ring Size M12 LH 5th digit	11.8 ring zize Standard Deviation 1.81	12.4 ring zize Standard Deviation 1.78	—
Ring Size Baseline right hand (RH) 4th digit	12.5 ring zize Standard Deviation 2.01	11.4 ring zize Standard Deviation 2.54	—
Ring Size Baseline right hand 5th digit	11.2 ring zize Standard Deviation 3.35	11.3 ring zize Standard Deviation 2.95	—
Ring Size M12 RH 4th digit	12.2 ring zize Standard Deviation 2.12	11.3 ring zize Standard Deviation 2.18	—
Ring Size M12 RH 5th digit	10.7 ring zize Standard Deviation 3.96	10.5 ring zize Standard Deviation 2.14	—
Ring Size M25 LH 4th digit	10.1 ring zize Standard Deviation 2.12	11.1 ring zize Standard Deviation 1.95	—
Ring Size M25 LH 5th digit	10.0 ring zize Standard Deviation 2.45	14.3 ring zize Standard Deviation 0.35	—
Ring Size M25 RH 4th digit	11.8 ring zize Standard Deviation 1.98	10.9 ring zize Standard Deviation 1.65	—
Ring Size M25 RH 5th digit	7.8 ring zize Standard Deviation 4.60	7.5 ring zize Standard Deviation NA N/A = Not applicable for Std. Dev.	—

SECONDARY outcome

Timeframe: Baseline, Months 12, 25

Population: Full Analysis Set: All patients who were randomized into the study.

Acromegalyy quality of life (AcroQoL) total scores. The AcroQoL questionnaire is unidimensional and contains 22 items divided in two scales: one that evaluates physical aspects (eight items) and another one that evaluates psychological aspects (14 items). The scoring of the questionnaire was performed as specified by the instrument developers. Total scores range from 0 to 100. Higher scores represent better quality of life. Analysis was based on data up to crossover (i.e., included data from both blinded core and extension phase up to 26 Months for patients who continued the same treatment in the extension. For patients who switched to the other treatment, only data collected before crossover was included).

Outcome measures

Measure	Pasireotide LAR (Core) n=176 Participants Includes data from the 12-month blinded core phase for patients randomized to receive Pasireotide LAR.	Octreotide LAR (Core) n=182 Participants Includes data from the 12-month blinded core phase for patients randomized to receive Octreotide LAR.	Pasireotide LAR 60mg Patients in this arm received Pasireotide LAR 60 mg injection prior to PK sample collection.
Health-related Quality-of-life as Measured by the AcroQoL Questionnaire Baseline	58.4 Score on a scale Standard Deviation 19.97	55.6 Score on a scale Standard Deviation 19.79	—
Health-related Quality-of-life as Measured by the AcroQoL Questionnaire M12	65.7 Score on a scale Standard Deviation 21.64	61.6 Score on a scale Standard Deviation 21.01	—
Health-related Quality-of-life as Measured by the AcroQoL Questionnaire M25	69.3 Score on a scale Standard Deviation 18.76	62.9 Score on a scale Standard Deviation 18.86	—

SECONDARY outcome

Timeframe: Baseline, Months 12, 25

Population: Full Analysis Set: All patients who were randomized into the study.

Prolactin Levels. Analysis was based on data up to crossover (i.e., included data from both blinded core and extension phase up to 26 Months for patients who continued the same treatment in the extension. For patients who switched to the other treatment, only data collected before crossover was included).

Outcome measures

Measure	Pasireotide LAR (Core) n=176 Participants Includes data from the 12-month blinded core phase for patients randomized to receive Pasireotide LAR.	Octreotide LAR (Core) n=182 Participants Includes data from the 12-month blinded core phase for patients randomized to receive Octreotide LAR.	Pasireotide LAR 60mg Patients in this arm received Pasireotide LAR 60 mg injection prior to PK sample collection.
Summary of Prolactin Levels Baseline	20.6 μg/L Standard Deviation 53.00	15.8 μg/L Standard Deviation 22.05	—
Summary of Prolactin Levels M12	8.9 μg/L Standard Deviation 19.24	11.7 μg/L Standard Deviation 19.09	—
Summary of Prolactin Levels M25	5.4 μg/L Standard Deviation 4.37	6.7 μg/L Standard Deviation 4.63	—

SECONDARY outcome

Timeframe: Up to 26 months

Population: Full Analysis Set: All patients who were randomized into the study.

The duration of response is defined as the time from the date that patient first met and maintained the response criteria based on primary efficacy variable to the date that patient lost response status.

Median and corresponding 95% CI are derived based on Kaplan-Meier method. Analysis was based on data up to crossover (i.e., included data from both blinded core and extension phase up to 26 Months for patients who continued the same treatment in the extension. For patients who switched to the other treatment, only data collected before crossover was included).

Outcome measures

Measure	Pasireotide LAR (Core) n=176 Participants Includes data from the 12-month blinded core phase for patients randomized to receive Pasireotide LAR.	Octreotide LAR (Core) n=182 Participants Includes data from the 12-month blinded core phase for patients randomized to receive Octreotide LAR.	Pasireotide LAR 60mg Patients in this arm received Pasireotide LAR 60 mg injection prior to PK sample collection.
Duration of Response for Patients Achieving a Reduction of Mean GH Level to <2.5 μg/L and the Normalization of IGF-1 at Month 12 (No. of Responders: Pasireotide LAR = 51, Octreotide LAR = 32)	64.4 Weeks Interval 52.1 to 100.4	64.6 Weeks Interval 40.0 to 92.0	—

SECONDARY outcome

Timeframe: Months 1 - 12

Population: PK analysis set: All patients with at least one LAR injection and one post-dose trough concentration data in core phase (up to month 12). No participants took the 60 mg dose in Months 1, 2 and 3, hence no data.

Pasireotide LAR trough concentrations by incident dose (last dose administered prior to PK sample collection). PK observations with missing concentrations, missing dose, missing elapsed time or an elapsed time from previous injection outside of 28±2 days window were excluded.

5 patients with evaluable PK data in the pasireotide arm received erroneously 20 mg pasireotide LAR at baseline.

Outcome measures

Measure	Pasireotide LAR (Core) n=172 Participants Includes data from the 12-month blinded core phase for patients randomized to receive Pasireotide LAR.	Octreotide LAR (Core) n=172 Participants Includes data from the 12-month blinded core phase for patients randomized to receive Octreotide LAR.	Pasireotide LAR 60mg n=172 Participants Patients in this arm received Pasireotide LAR 60 mg injection prior to PK sample collection.
Pasireotide Trough Concentrations by Incident Dose M1	4.65 ng/mL Standard Deviation 0.645	6.65 ng/mL Standard Deviation 3.641	—
Pasireotide Trough Concentrations by Incident Dose M2	2.88 ng/mL Standard Deviation 1.371	7.81 ng/mL Standard Deviation 3.505	—
Pasireotide Trough Concentrations by Incident Dose M3	3.39 ng/mL Standard Deviation 2.659	8.70 ng/mL Standard Deviation 5.402	—
Pasireotide Trough Concentrations by Incident Dose M5	5.22 ng/mL Standard Deviation 4.077	10.92 ng/mL Standard Deviation 6.017	13.42 ng/mL Standard Deviation 6.902
Pasireotide Trough Concentrations by Incident Dose M6	2.87 ng/mL Standard Deviation 1.101	10.59 ng/mL Standard Deviation 6.216	13.08 ng/mL Standard Deviation 6.967
Pasireotide Trough Concentrations by Incident Dose M7	2.29 ng/mL Standard Deviation 0.857	11.85 ng/mL Standard Deviation 7.781	14.76 ng/mL Standard Deviation 6.868
Pasireotide Trough Concentrations by Incident Dose M8	3.65 ng/mL Standard Deviation 1.865	12.33 ng/mL Standard Deviation 7.619	15.88 ng/mL Standard Deviation 9.073
Pasireotide Trough Concentrations by Incident Dose M9	4.80 ng/mL Standard Deviation 1.957	12.75 ng/mL Standard Deviation 8.604	16.03 ng/mL Standard Deviation 10.852
Pasireotide Trough Concentrations by Incident Dose M10	5.66 ng/mL Standard Deviation 3.606	12.42 ng/mL Standard Deviation 7.252	16.01 ng/mL Standard Deviation 11.497
Pasireotide Trough Concentrations by Incident Dose M11	5.10 ng/mL Standard Deviation 2.375	12.62 ng/mL Standard Deviation 6.920	16.31 ng/mL Standard Deviation 10.596
Pasireotide Trough Concentrations by Incident Dose M4	3.93 ng/mL Standard Deviation 1.858	9.51 ng/mL Standard Deviation 5.487	13.48 ng/mL Standard Deviation 7.750
Pasireotide Trough Concentrations by Incident Dose M12	4.54 ng/mL Standard Deviation 1.634	11.11 ng/mL Standard Deviation 6.489	16.16 ng/mL Standard Deviation 9.323

SECONDARY outcome

Timeframe: Months 1 - 12

Population: PK analysis set: All patients with at least one LAR injection and one post-dose trough concentration data in core phase (up to month 12). No participants took the 30 mg dose in Months 1, 2 and 3, hence no data.

Octreotide LAR trough concentrations by incident dose (last dose administered prior to PK sample collection). PK observations with missing concentrations, missing dose, missing elapsed time or an elapsed time from previous injection outside of 28±2 days window were excluded.

Outcome measures

Measure	Pasireotide LAR (Core) n=178 Participants Includes data from the 12-month blinded core phase for patients randomized to receive Pasireotide LAR.	Octreotide LAR (Core) n=178 Participants Includes data from the 12-month blinded core phase for patients randomized to receive Octreotide LAR.	Pasireotide LAR 60mg n=178 Participants Patients in this arm received Pasireotide LAR 60 mg injection prior to PK sample collection.
Octreotide Trough Concentrations by Incident Dose M1	—	0.86 ng/mL Standard Deviation 0.493	—
Octreotide Trough Concentrations by Incident Dose M2	0.61 ng/mL Standard Deviation 0.280	1.21 ng/mL Standard Deviation 0.663	—
Octreotide Trough Concentrations by Incident Dose M6	1.33 ng/mL Standard Deviation 0.754	1.58 ng/mL Standard Deviation 0.811	2.12 ng/mL Standard Deviation 0.990
Octreotide Trough Concentrations by Incident Dose M10	—	1.66 ng/mL Standard Deviation 0.995	2.50 ng/mL Standard Deviation 1.194
Octreotide Trough Concentrations by Incident Dose M11	—	1.74 ng/mL Standard Deviation 0.890	2.39 ng/mL Standard Deviation 1.103
Octreotide Trough Concentrations by Incident Dose M3	0.62 ng/mL Standard Deviation 0.107	1.29 ng/mL Standard Deviation 0.654	—
Octreotide Trough Concentrations by Incident Dose M4	0.19 ng/mL Standard Deviation NA N/A = Insufficient number of participants to calculate standard deviation.	1.45 ng/mL Standard Deviation 0.653	1.55 ng/mL Standard Deviation 0.658
Octreotide Trough Concentrations by Incident Dose M5	—	1.65 ng/mL Standard Deviation 0.876	2.14 ng/mL Standard Deviation 1.156
Octreotide Trough Concentrations by Incident Dose M7	0.70 ng/mL Standard Deviation NA N/A = Insufficient number of participants to calculate standard deviation.	1.46 ng/mL Standard Deviation 0.704	2.14 ng/mL Standard Deviation 1.009
Octreotide Trough Concentrations by Incident Dose M8	—	1.55 ng/mL Standard Deviation 0.727	2.16 ng/mL Standard Deviation 1.127
Octreotide Trough Concentrations by Incident Dose M9	—	1.74 ng/mL Standard Deviation 1.013	2.20 ng/mL Standard Deviation 0.992
Octreotide Trough Concentrations by Incident Dose M12	0.30 ng/mL Standard Deviation NA N/A = Insufficient number of participants to calculate standard deviation.	1.58 ng/mL Standard Deviation 0.695	2.55 ng/mL Standard Deviation 1.252

SECONDARY outcome

Timeframe: Months 3, 6, 9, 12 after crossover

Population: Crossover Analysis Set (CAS): All patients whose first dose in the extension is different from the first dose in the core. Patients were analyzed according to the crossover treatment received.

Percentage of participants with a reduction of mean GH levels to < 2.5μg/L (based on a 5-point 2-hour profile) and normalization of sex- and age-adjusted IGF-1. Analysis was based on data after crossover (i.e., included data from blinded extension phase collected after the crossover time point for patients who crossed over). Denominator for all time points is the Crossover Analysis Set (CAS).

Outcome measures

Measure	Pasireotide LAR (Core) n=81 Participants Includes data from the 12-month blinded core phase for patients randomized to receive Pasireotide LAR.	Octreotide LAR (Core) n=38 Participants Includes data from the 12-month blinded core phase for patients randomized to receive Octreotide LAR.	Pasireotide LAR 60mg Patients in this arm received Pasireotide LAR 60 mg injection prior to PK sample collection.
Percentage of Participants With a Reduction of Mean GH Level to < 2.5μg/L and Normalization of IGF-1 After Crossover M3 after crossover	17.3 Percentage of participants Interval 9.8 to 27.3	2.6 Percentage of participants Interval 0.1 to 13.8	—
Percentage of Participants With a Reduction of Mean GH Level to < 2.5μg/L and Normalization of IGF-1 After Crossover M6 after crossover	21.0 Percentage of participants Interval 12.7 to 31.5	2.6 Percentage of participants Interval 0.1 to 13.8	—
Percentage of Participants With a Reduction of Mean GH Level to < 2.5μg/L and Normalization of IGF-1 After Crossover M9 after crossover	22.2 Percentage of participants Interval 13.7 to 32.8	5.3 Percentage of participants Interval 0.6 to 17.7	—
Percentage of Participants With a Reduction of Mean GH Level to < 2.5μg/L and Normalization of IGF-1 After Crossover M12 after crossover	17.3 Percentage of participants Interval 9.8 to 27.3	0.0 Percentage of participants N/A = For zero proportions, confidence intervals were not calculated	—

SECONDARY outcome

Timeframe: Months 3, 6, 9, 12, 16, 19, 22, 25

Population: Full Analysis Set: All patients who were randomized into the study.

Percentage of participants with a reduction of mean GH levels to < 2.5μg/L (based on a 5-point 2-hour profile).

Analysis was based on data up to crossover (i.e., included data from both blinded core and extension phase up to 26 Months for patients who continued the same treatment in the extension. For patients who switched to the other treatment, only data collected before crossover was included). Denominator for time points up to Month 12 is the Full Analysis Set. Denominator for time points after Month 12 excludes patients who completed the core and did not enter the extension. Patients who discontinued were considered non-responders for the time points after discontinuation, patients who crossed over were considered non-responders for all time points after crossover.

Outcome measures

Measure	Pasireotide LAR (Core) n=176 Participants Includes data from the 12-month blinded core phase for patients randomized to receive Pasireotide LAR.	Octreotide LAR (Core) n=182 Participants Includes data from the 12-month blinded core phase for patients randomized to receive Octreotide LAR.	Pasireotide LAR 60mg Patients in this arm received Pasireotide LAR 60 mg injection prior to PK sample collection.
Percentage of Participants With a Reduction of Mean GH Level to < 2.5μg/L M9	42.6 Percentage of participants Interval 35.2 to 50.3	46.2 Percentage of participants Interval 38.8 to 53.7	—
Percentage of Participants With a Reduction of Mean GH Level to < 2.5μg/L M12	43.2 Percentage of participants Interval 35.8 to 50.8	47.3 Percentage of participants Interval 39.8 to 54.8	—
Percentage of Participants With a Reduction of Mean GH Level to < 2.5μg/L M22	35.4 Percentage of participants Interval 27.7 to 43.7	22.2 Percentage of participants Interval 15.9 to 29.6	—
Percentage of Participants With a Reduction of Mean GH Level to < 2.5μg/L M3	49.4 Percentage of participants Interval 41.8 to 57.1	43.4 Percentage of participants Interval 36.1 to 50.9	—
Percentage of Participants With a Reduction of Mean GH Level to < 2.5μg/L M6	45.5 Percentage of participants Interval 37.9 to 53.1	47.8 Percentage of participants Interval 40.4 to 55.3	—
Percentage of Participants With a Reduction of Mean GH Level to < 2.5μg/L M16	33.3 Percentage of participants Interval 25.8 to 41.6	22.2 Percentage of participants Interval 15.9 to 29.6	—
Percentage of Participants With a Reduction of Mean GH Level to < 2.5μg/L M19	36.7 Percentage of participants Interval 28.9 to 45.1	21.6 Percentage of participants Interval 15.3 to 28.9	—
Percentage of Participants With a Reduction of Mean GH Level to < 2.5μg/L M25	35.4 Percentage of participants Interval 27.7 to 43.7	24.2 Percentage of participants Interval 17.6 to 31.8	—

SECONDARY outcome

Timeframe: Months 3, 6, 9, 12, 16, 19, 22, 25

Population: Full Analysis Set: All patients who were randomized into the study.

Percentage of participants with normalization of sex- and age-adjusted IGF-1. Analysis was based on data up to crossover (i.e., included data from both blinded core and extension phase up to 26 Months for patients who continued the same treatment in the extension. For patients who switched to the other treatment, only data collected before crossover was included). Denominator for time points up to Month 12 is the FAS. Denominator for time points after Month 12 excludes patients who completed the core and did not enter the extension. Patients who discontinued were considered non-responders for the time points after discontinuation, patients who crossed over were considered non-responders for all time points after crossover.

Outcome measures

Measure	Pasireotide LAR (Core) n=176 Participants Includes data from the 12-month blinded core phase for patients randomized to receive Pasireotide LAR.	Octreotide LAR (Core) n=182 Participants Includes data from the 12-month blinded core phase for patients randomized to receive Octreotide LAR.	Pasireotide LAR 60mg Patients in this arm received Pasireotide LAR 60 mg injection prior to PK sample collection.
Percentage of Participants With Normalization of IGF-1 M19	25.2 Percentage of participants Interval 18.4 to 33.0	15.7 Percentage of participants Interval 10.3 to 22.4	—
Percentage of Participants With Normalization of IGF-1 M22	25.9 Percentage of participants Interval 19.0 to 33.7	17.0 Percentage of participants Interval 11.4 to 23.9	—
Percentage of Participants With Normalization of IGF-1 M25	25.9 Percentage of participants Interval 19.0 to 33.7	14.4 Percentage of participants Interval 9.2 to 21.0	—
Percentage of Participants With Normalization of IGF-1 M3	35.2 Percentage of participants Interval 28.2 to 42.8	25.3 Percentage of participants Interval 19.1 to 32.2	—
Percentage of Participants With Normalization of IGF-1 M6	35.8 Percentage of participants Interval 28.7 to 43.4	24.2 Percentage of participants Interval 18.1 to 31.1	—
Percentage of Participants With Normalization of IGF-1 M9	34.1 Percentage of participants Interval 27.1 to 41.6	28.0 Percentage of participants Interval 21.6 to 35.1	—
Percentage of Participants With Normalization of IGF-1 M12	35.8 Percentage of participants Interval 28.7 to 43.4	22.0 Percentage of participants Interval 16.2 to 28.7	—
Percentage of Participants With Normalization of IGF-1 M16	29.9 Percentage of participants Interval 22.7 to 38.0	13.7 Percentage of participants Interval 8.7 to 20.2	—

SECONDARY outcome

Timeframe: Baseline, months 6, 12, 19, 25

Population: Full Analysis Set: All patients who were randomized into the study.

Percentage change from baseline in tumor volume (assessed by pituitary MRI). Analysis was based on data up to crossover (i.e., included data from both blinded core and extension phase up to 26 Months for patients who continued the same treatment in the extension. For patients who switched to the other treatment, only data collected before crossover was included).

Outcome measures

Measure	Pasireotide LAR (Core) n=176 Participants Includes data from the 12-month blinded core phase for patients randomized to receive Pasireotide LAR.	Octreotide LAR (Core) n=182 Participants Includes data from the 12-month blinded core phase for patients randomized to receive Octreotide LAR.	Pasireotide LAR 60mg Patients in this arm received Pasireotide LAR 60 mg injection prior to PK sample collection.
Change From Baseline in Tumor Volume % change at M6	-29.9 mm^3 Standard Deviation 21.73	-28.8 mm^3 Standard Deviation 20.22	—
Change From Baseline in Tumor Volume % change at M12	-39.7 mm^3 Standard Deviation 21.83	-38.0 mm^3 Standard Deviation 24.47	—
Change From Baseline in Tumor Volume Baseline	2420.7 mm^3 Standard Deviation 4159.21	2259.2 mm^3 Standard Deviation 3390.20	—
Change From Baseline in Tumor Volume M6	1614.1 mm^3 Standard Deviation 2536.46	1565.4 mm^3 Standard Deviation 2245.99	—
Change From Baseline in Tumor Volume M12	1482.4 mm^3 Standard Deviation 2387.88	1390.4 mm^3 Standard Deviation 2179.93	—
Change From Baseline in Tumor Volume M19	956.6 mm^3 Standard Deviation 1806.72	1009.9 mm^3 Standard Deviation 1578.75	—
Change From Baseline in Tumor Volume M25	840.4 mm^3 Standard Deviation 1706.07	814.1 mm^3 Standard Deviation 1306.58	—
Change From Baseline in Tumor Volume % change at M19	-48.9 mm^3 Standard Deviation 22.81	-47.2 mm^3 Standard Deviation 24.08	—
Change From Baseline in Tumor Volume % change at M25	-51.8 mm^3 Standard Deviation 20.81	-55.0 mm^3 Standard Deviation 21.27	—

SECONDARY outcome

Timeframe: Months 3, 6, 9, 12 after crossover

Population: CAS: All patients whose first dose in the extension is different from the first dose in the core. Patients were analyzed according to the crossover treatment received.

Percentage of participants with a reduction of mean GH levels to < 2.5μg/L (based on a 5-point 2-hour profile). Analysis was based on data after crossover (i.e., included data from blinded extension phase collected after the crossover time point for patients who crossed over). Denominator for all time points is the Crossover Analysis Set (CAS).

Outcome measures

Measure	Pasireotide LAR (Core) n=81 Participants Includes data from the 12-month blinded core phase for patients randomized to receive Pasireotide LAR.	Octreotide LAR (Core) n=38 Participants Includes data from the 12-month blinded core phase for patients randomized to receive Octreotide LAR.	Pasireotide LAR 60mg Patients in this arm received Pasireotide LAR 60 mg injection prior to PK sample collection.
Percentage of Participants With a Reduction of Mean GH Level to < 2.5μg/L After Crossover M3 after crossover	49.4 Percentage of participants Interval 38.1 to 60.7	28.9 Percentage of participants Interval 15.4 to 45.9	—
Percentage of Participants With a Reduction of Mean GH Level to < 2.5μg/L After Crossover M6 after crossover	43.2 Percentage of participants Interval 32.2 to 54.7	31.6 Percentage of participants Interval 17.5 to 48.7	—
Percentage of Participants With a Reduction of Mean GH Level to < 2.5μg/L After Crossover M9 after crossover	54.3 Percentage of participants Interval 42.9 to 65.4	31.6 Percentage of participants Interval 17.5 to 48.7	—
Percentage of Participants With a Reduction of Mean GH Level to < 2.5μg/L After Crossover M12 after crossover	44.4 Percentage of participants Interval 33.4 to 55.9	23.7 Percentage of participants Interval 11.4 to 40.2	—

SECONDARY outcome

Timeframe: Months 3, 6, 9, 12 after crossover

Population: CAS: All patients whose first dose in the extension is different from the first dose in the core. Patients were analyzed according to the crossover treatment received.

Percentage of participants with normalization of sex- and age-adjusted IGF-1. Analysis was based on data after crossover (i.e., included data from blinded extension phase collected after the crossover time point for patients who crossed over). Denominator for all time points is the Crossover Analysis Set (CAS).

Outcome measures

Measure	Pasireotide LAR (Core) n=81 Participants Includes data from the 12-month blinded core phase for patients randomized to receive Pasireotide LAR.	Octreotide LAR (Core) n=38 Participants Includes data from the 12-month blinded core phase for patients randomized to receive Octreotide LAR.	Pasireotide LAR 60mg Patients in this arm received Pasireotide LAR 60 mg injection prior to PK sample collection.
Percentage of Participants With Normalization of IGF-1 After Crossover M9 after crossover	29.6 Percentage of participants Interval 20.0 to 40.8	10.5 Percentage of participants Interval 2.9 to 24.8	—
Percentage of Participants With Normalization of IGF-1 After Crossover M12 after crossover	27.2 Percentage of participants Interval 17.9 to 38.2	5.3 Percentage of participants Interval 0.6 to 17.7	—
Percentage of Participants With Normalization of IGF-1 After Crossover M3 after crossover	19.8 Percentage of participants Interval 11.7 to 30.1	7.9 Percentage of participants Interval 1.7 to 21.4	—
Percentage of Participants With Normalization of IGF-1 After Crossover M6 after crossover	30.9 Percentage of participants Interval 21.1 to 42.1	7.9 Percentage of participants Interval 1.7 to 21.4	—

SECONDARY outcome

Timeframe: Extension baseline, months 3, 6, 9, 12 after crossover

Population: CAS: All patients whose first dose in the extension is different from the first dose in the core. Patients were analyzed according to the crossover treatment received.

Mean GH levels (based on a 5-point profile over 2 hours). Extension baseline was defined as last measurement prior to the start of crossover treatment. Analysis was based on data after crossover (i.e., included data from blinded extension phase collected after the crossover time point for patients who crossed over).

Outcome measures

Measure	Pasireotide LAR (Core) n=81 Participants Includes data from the 12-month blinded core phase for patients randomized to receive Pasireotide LAR.	Octreotide LAR (Core) n=38 Participants Includes data from the 12-month blinded core phase for patients randomized to receive Octreotide LAR.	Pasireotide LAR 60mg Patients in this arm received Pasireotide LAR 60 mg injection prior to PK sample collection.
Summary of Mean GH Values After Crossover Ext. Baseline	5.9 μg/L Standard Deviation 15.02	7.1 μg/L Standard Deviation 9.80	—
Summary of Mean GH Values After Crossover M3 after crossover	5.9 μg/L Standard Deviation 19.70	9.8 μg/L Standard Deviation 17.09	—
Summary of Mean GH Values After Crossover M6 after crossover	4.8 μg/L Standard Deviation 14.51	9.8 μg/L Standard Deviation 20.49	—
Summary of Mean GH Values After Crossover M9 after crossover	2.6 μg/L Standard Deviation 3.03	8.7 μg/L Standard Deviation 19.26	—
Summary of Mean GH Values After Crossover M12 after crossover	2.5 μg/L Standard Deviation 2.47	10.4 μg/L Standard Deviation 26.00	—

SECONDARY outcome

Timeframe: Extension baseline, months 6, 12 after crossover

Population: CAS: All patients whose first dose in the extension is different from the first dose in the core. Patients were analyzed according to the crossover treatment received.

Percentage change from extension baseline in tumor volume (assessed by pituitary MRI).

Extension baseline was defined as last assessment prior to the administration of the new treatment after crossover. Analysis was based on data after crossover (i.e., included data from blinded extension phase collected after the crossover time point for patients who crossed over).

Outcome measures

Measure	Pasireotide LAR (Core) n=81 Participants Includes data from the 12-month blinded core phase for patients randomized to receive Pasireotide LAR.	Octreotide LAR (Core) n=38 Participants Includes data from the 12-month blinded core phase for patients randomized to receive Octreotide LAR.	Pasireotide LAR 60mg Patients in this arm received Pasireotide LAR 60 mg injection prior to PK sample collection.
Change From Extension Baseline in Tumor Volume After Crossover Value at M6 after crossover	1027.5 mm^3 Standard Deviation 1282.42	1794.9 mm^3 Standard Deviation 2823.08	—
Change From Extension Baseline in Tumor Volume After Crossover % change - M6 after crossover	-18.1 mm^3 Standard Deviation 17.68	-12.3 mm^3 Standard Deviation 24.11	—
Change From Extension Baseline in Tumor Volume After Crossover Value at M12 after crossover	949.0 mm^3 Standard Deviation 1169.49	1610.4 mm^3 Standard Deviation 2666.66	—
Change From Extension Baseline in Tumor Volume After Crossover % change - M12 after crossover	-24.7 mm^3 Standard Deviation 25.20	-17.9 mm^3 Standard Deviation 27.80	—
Change From Extension Baseline in Tumor Volume After Crossover Ext. Baseline	1420.9 mm^3 Standard Deviation 1914.58	1809.6 mm^3 Standard Deviation 2579.25	—

SECONDARY outcome

Timeframe: Extension baseline, month 12 after crossover

Population: CAS: All patients whose first dose in the extension is different from the first dose in the core. Patients were analyzed according to the crossover treatment received.

Severity scores of acromegaly symptoms (Headache, Fatigue, Perspiration, Paresthesias, Osteoarthralgia).

Symptoms were scored from 0 (no symptom) to 4 (very severe). Extension baseline was defined as last measurement prior to the start of crossover treatment. Analysis was based on data after crossover (i.e., included data from blinded extension phase collected after the crossover time point for patients who crossed over).

Outcome measures

Measure	Pasireotide LAR (Core) n=81 Participants Includes data from the 12-month blinded core phase for patients randomized to receive Pasireotide LAR.	Octreotide LAR (Core) n=38 Participants Includes data from the 12-month blinded core phase for patients randomized to receive Octreotide LAR.	Pasireotide LAR 60mg Patients in this arm received Pasireotide LAR 60 mg injection prior to PK sample collection.
Severity Scores of Acromegaly Symptoms After Crossover Headache: M12 after crossover	0.5 scores on a scale Standard Deviation 0.83	0.7 scores on a scale Standard Deviation 0.79	—
Severity Scores of Acromegaly Symptoms After Crossover Fatigue: Ext. BL	0.8 scores on a scale Standard Deviation 1.07	0.7 scores on a scale Standard Deviation 0.76	—
Severity Scores of Acromegaly Symptoms After Crossover Perspiration: M12 after crossover	0.6 scores on a scale Standard Deviation 0.98	0.5 scores on a scale Standard Deviation 0.80	—
Severity Scores of Acromegaly Symptoms After Crossover Paresthesia: Ext. BL	0.4 scores on a scale Standard Deviation 0.75	0.4 scores on a scale Standard Deviation .054	—
Severity Scores of Acromegaly Symptoms After Crossover Osteoarthralgia: Ext. BL	0.6 scores on a scale Standard Deviation 0.91	0.6 scores on a scale Standard Deviation 0.79	—
Severity Scores of Acromegaly Symptoms After Crossover Osteoarthralgia: M12 after crossover	0.5 scores on a scale Standard Deviation 0.89	0.7 scores on a scale Standard Deviation 0.86	—
Severity Scores of Acromegaly Symptoms After Crossover Headache: Ext. BL	0.6 scores on a scale Standard Deviation 0.89	0.4 scores on a scale Standard Deviation 0.60	—
Severity Scores of Acromegaly Symptoms After Crossover Fatigue: M12 after crossover	0.8 scores on a scale Standard Deviation 0.91	0.7 scores on a scale Standard Deviation 0.68	—
Severity Scores of Acromegaly Symptoms After Crossover Perspiration: Ext. BL	0.5 scores on a scale Standard Deviation 0.85	0.6 scores on a scale Standard Deviation 0.86	—
Severity Scores of Acromegaly Symptoms After Crossover Paresthesia: M12 after crossover	0.3 scores on a scale Standard Deviation 0.56	0.4 scores on a scale Standard Deviation 0.76	—

SECONDARY outcome

Timeframe: Extension baseline, month 12 after crossover

Population: CAS: All patients whose first dose in the extension is different from the first dose in the core. Patients were analyzed according to the crossover treatment received. In the extension baseline, no participant had ring size on their right hand measured at the 5th digit, hence no data.

Ring size (based on jeweler's finger gauge). Extension baseline was defined as last measurement prior to the start of crossover treatment. Analysis was based on data after crossover (i.e., included data from blinded extension phase collected after the crossover time point for patients who crossed over). BL = baseline, LH = left hand, RH = right hand, CO = crossover

Outcome measures

Measure	Pasireotide LAR (Core) n=81 Participants Includes data from the 12-month blinded core phase for patients randomized to receive Pasireotide LAR.	Octreotide LAR (Core) n=38 Participants Includes data from the 12-month blinded core phase for patients randomized to receive Octreotide LAR.	Pasireotide LAR 60mg Patients in this arm received Pasireotide LAR 60 mg injection prior to PK sample collection.
Ring Size After Crossover Ext. BL LH 5th digit	11.6 ring size Standard Deviation 1.88	12.3 ring size Standard Deviation 2.46	—
Ring Size After Crossover M12 after CO RH 4th digit	11.6 ring size Standard Deviation 2.95	11.4 ring size Standard Deviation 2.56	—
Ring Size After Crossover M12 after CO RH 5th digit	11.5 ring size Standard Deviation 0.00	—	—
Ring Size After Crossover Ext. BL LH 4th digit	11.2 ring size Standard Deviation 2.10	11.0 ring size Standard Deviation 1.87	—
Ring Size After Crossover Ext. BL RH 4th digit	11.4 ring size Standard Deviation 2.42	12.4 ring size Standard Deviation 2.11	—
Ring Size After Crossover Ext. BL RH 5th digit	10.7 ring size Standard Deviation 2.31	—	—
Ring Size After Crossover M12 after CO LH 4th digit	10.9 ring size Standard Deviation 2.27	11.2 ring size Standard Deviation 2.01	—
Ring Size After Crossover M12 after CO LH 5th digit CO	11.9 ring size Standard Deviation 2.14	12.5 ring size Standard Deviation 1.35	—

SECONDARY outcome

Timeframe: Extension baseline, months 12 after crossover

Population: CAS: All patients whose first dose in the extension is different from the first dose in the core. Patients were analyzed according to the crossover treatment received.

AcroQoL total scores. The AcroQoL questionnaire is unidimensional and contains 22 items divided in two scales: one that evaluates physical aspects (eight items) and another one that evaluates psychological aspects (14 items). The scoring of the questionnaire was performed as specified by the instrument developers. Extension baseline was defined as last measurement prior to the start of crossover treatment. Analysis was based on data after crossover (i.e., included data from blinded extension phase collected after the crossover time point for patients who crossed over). Total scores range from 0 to 100. Higher scores represent better quality of life.

Outcome measures

Measure	Pasireotide LAR (Core) n=81 Participants Includes data from the 12-month blinded core phase for patients randomized to receive Pasireotide LAR.	Octreotide LAR (Core) n=38 Participants Includes data from the 12-month blinded core phase for patients randomized to receive Octreotide LAR.	Pasireotide LAR 60mg Patients in this arm received Pasireotide LAR 60 mg injection prior to PK sample collection.
Health-related Quality-of-life as Measured by the AcroQoL Questionnaire After Crossover M12 after crossover	60.3 scores on a scale Standard Deviation 24.34	61.2 scores on a scale Standard Deviation 21.62	—
Health-related Quality-of-life as Measured by the AcroQoL Questionnaire After Crossover Ext. Baseline	58.9 scores on a scale Standard Deviation 23.11	59.8 scores on a scale Standard Deviation 22.40	—

SECONDARY outcome

Timeframe: Extension baseline, month 12 after crossover

Population: CAS: All patients whose first dose in the extension is different from the first dose in the core. Patients were analyzed according to the crossover treatment received.

Prolactin (PRL) levels. Analysis was based on data after crossover (i.e., included data from blinded extension phase collected after the crossover time point for patients who crossed over). Extension baseline was defined as last measurement prior to the start of crossover treatment.

Outcome measures

Measure	Pasireotide LAR (Core) n=81 Participants Includes data from the 12-month blinded core phase for patients randomized to receive Pasireotide LAR.	Octreotide LAR (Core) n=38 Participants Includes data from the 12-month blinded core phase for patients randomized to receive Octreotide LAR.	Pasireotide LAR 60mg Patients in this arm received Pasireotide LAR 60 mg injection prior to PK sample collection.
Summary of Prolactin Levels After Crossover Ext. Baseline	11.9 μg/L Standard Deviation 18.42	15.7 μg/L Standard Deviation 36.76	—
Summary of Prolactin Levels After Crossover M12 after crossover	7.5 μg/L Standard Deviation 8.95	16.1 μg/L Standard Deviation 25.37	—

Adverse Events

Pasireotide LAR - up to 26 Months

Serious events: 35 serious events

Other events: 169 other events

Deaths: 0 deaths

Octreotide LAR - up to 26 Months

Serious events: 28 serious events

Other events: 161 other events

Deaths: 0 deaths

Crossed Over to Pasireotide LAR - up to 26 Months

Serious events: 8 serious events

Other events: 74 other events

Deaths: 0 deaths

Crossed Over to Octreotide LAR - up to 26 Months

Serious events: 6 serious events

Other events: 33 other events

Deaths: 0 deaths

Pasireotide LAR - up to EOS

Serious events: 37 serious events

Other events: 170 other events

Deaths: 0 deaths

Crossed Over to Pasireotide LAR - up to EOS

Serious events: 12 serious events

Other events: 76 other events

Deaths: 0 deaths

Serious adverse events

Measure	Pasireotide LAR - up to 26 Months n=178 participants at risk Includes data from both blinded core and extension phase (up to Month 26 cutoff date of 29-Dec-2011) for patients who continued the same treatment (Pasireotide LAR) as in the core. For patients who switched from blinded Pasireotide LAR to Octreotide LAR treatment, only data collected before crossover is included.	Octreotide LAR - up to 26 Months n=180 participants at risk Includes data from both blinded core and extension phase (up to Month 26 cutoff date of 29-Dec-2011) for patients who continued the same treatment (Octreotide LAR) as in the core. For patients who switched from blinded Octreotide LAR to Pasireotide LAR treatment, only data collected before crossover is included.	Crossed Over to Pasireotide LAR - up to 26 Months n=81 participants at risk Includes all data in the extension phase (up to 26-Month cutoff date of 29-Dec-2011) collected after the crossover time point for patients who crossed over from Octreotide LAR in the core to Pasireotide LAR treatment in the extension phase.	Crossed Over to Octreotide LAR - up to 26 Months n=38 participants at risk Includes all data in the extension phase (up to 26-Month cutoff date of 29-Dec-2011) collected after the crossover time point for patients who crossed over from Pasireotide LAR in the core to Octreotide LAR treatment in the extension phase.	Pasireotide LAR - up to EOS n=178 participants at risk Includes data from both core and extension phase (up to End-of-study date of 11-Mar-2016) for patients who continued the same treatment (Pasireotide LAR) as in the core. For patients who switched from blinded Pasireotide LAR to Octreotide LAR treatment, only data collected before crossover is included. Per protocol, patients on Pasireotide LAR could continue to receive open-label Pasireotide LAR after treatment unblinding at Month 26, whereas those on Octreotide LAR were not followed after Month 26.	Crossed Over to Pasireotide LAR - up to EOS n=81 participants at risk Includes all data in the extension phase (up to End-of-study date of 11-Mar-2016) collected after the crossover time point for patients who crossed over from Octreotide LAR in the core to Pasireotide LAR treatment in the extension phase. Per protocol, patients on Pasireotide LAR could continue to receive open-label Pasireotide LAR after treatment unblinding at Month 26, whereas those on Octreotide LAR were not followed after Month 26.
Gastrointestinal disorders Pancreatic cyst	0.00% 0/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.56% 1/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Gastrointestinal disorders Pancreatitis acute	0.56% 1/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.56% 1/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Gastrointestinal disorders Vomiting	0.00% 0/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	1.2% 1/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
General disorders Chills	0.00% 0/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.56% 1/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Blood and lymphatic system disorders Neutropenia	0.56% 1/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.56% 1/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Cardiac disorders Acute myocardial infarction	0.00% 0/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	2.6% 1/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Cardiac disorders Angina unstable	0.00% 0/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	2.6% 1/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Cardiac disorders Atrial fibrillation	0.56% 1/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.56% 1/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Cardiac disorders Cardiac arrest	0.00% 0/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.56% 1/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Cardiac disorders Cardiovascular disorder	0.56% 1/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.56% 1/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Cardiac disorders Myocardial infarction	0.00% 0/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.56% 1/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Cardiac disorders Myocardial ischaemia	0.00% 0/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	2.6% 1/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Ear and labyrinth disorders Hypoacusis	0.56% 1/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.56% 1/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Endocrine disorders Acromegaly	1.1% 2/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	1.1% 2/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Endocrine disorders Adrenal insufficiency	0.00% 0/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.56% 1/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Endocrine disorders Toxic nodular goitre	0.00% 0/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.56% 1/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Gastrointestinal disorders Abdominal pain	0.00% 0/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.56% 1/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	1.2% 1/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	1.2% 1/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	1.1% 2/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Gastrointestinal disorders Anal fissure	0.56% 1/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.56% 1/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Gastrointestinal disorders Colitis	0.00% 0/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.56% 1/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Gastrointestinal disorders Constipation	0.00% 0/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	1.2% 1/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	2.5% 2/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Gastrointestinal disorders Diarrhoea	0.00% 0/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.56% 1/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Gastrointestinal disorders Gastritis	0.00% 0/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.56% 1/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Gastrointestinal disorders Haemorrhoids	0.56% 1/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.56% 1/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Gastrointestinal disorders Intestinal obstruction	0.00% 0/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.56% 1/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	1.2% 1/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	1.2% 1/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Gastrointestinal disorders Irritable bowel syndrome	0.00% 0/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.56% 1/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Gastrointestinal disorders Large intestine polyp	0.00% 0/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.56% 1/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Gastrointestinal disorders Nausea	0.00% 0/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	1.2% 1/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	1.2% 1/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Gastrointestinal disorders Oesophageal obstruction	0.00% 0/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	1.2% 1/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
General disorders Concomitant disease progression	1.1% 2/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	1.1% 2/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
General disorders Fatigue	0.56% 1/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.56% 1/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
General disorders Hernia	0.00% 0/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.56% 1/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
General disorders Multi-organ failure	0.00% 0/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.56% 1/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
General disorders Oedema peripheral	0.56% 1/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.56% 1/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
General disorders Pyrexia	0.00% 0/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.56% 1/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	1.2% 1/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	1.2% 1/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Hepatobiliary disorders Cholecystitis	1.1% 2/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.56% 1/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	1.1% 2/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Hepatobiliary disorders Cholecystitis acute	1.1% 2/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.56% 1/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	1.7% 3/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Hepatobiliary disorders Cholelithiasis	2.8% 5/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	2.2% 4/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	2.5% 2/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	2.6% 1/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	2.8% 5/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	3.7% 3/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Hepatobiliary disorders Hydrocholecystis	0.00% 0/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.56% 1/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Infections and infestations Appendicitis	0.00% 0/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.56% 1/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Infections and infestations Febrile infection	0.56% 1/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.56% 1/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Infections and infestations Gastroenteritis	0.00% 0/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.56% 1/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Infections and infestations Influenza	0.00% 0/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.56% 1/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Infections and infestations Pneumonia bacterial	0.00% 0/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.56% 1/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Infections and infestations Pyelonephritis	0.00% 0/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.56% 1/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Infections and infestations Rectal abscess	0.00% 0/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.56% 1/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Infections and infestations Renal abscess	0.00% 0/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.56% 1/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Infections and infestations Septic shock	0.00% 0/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.56% 1/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Infections and infestations Tonsillitis	0.00% 0/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	1.2% 1/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	1.2% 1/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Infections and infestations Urinary tract infection	0.56% 1/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.56% 1/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.56% 1/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Injury, poisoning and procedural complications Back injury	0.56% 1/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.56% 1/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Injury, poisoning and procedural complications Brain contusion	0.00% 0/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	1.2% 1/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	1.2% 1/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Injury, poisoning and procedural complications Contusion	0.00% 0/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	1.2% 1/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.56% 1/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	1.2% 1/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Injury, poisoning and procedural complications Facial bones fracture	0.00% 0/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	1.2% 1/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.56% 1/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	1.2% 1/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Injury, poisoning and procedural complications Fibula fracture	0.56% 1/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.56% 1/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Injury, poisoning and procedural complications Head injury	0.00% 0/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	1.2% 1/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	1.2% 1/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Injury, poisoning and procedural complications Jaw fracture	0.00% 0/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.56% 1/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Injury, poisoning and procedural complications Kidney rupture	0.00% 0/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.56% 1/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Injury, poisoning and procedural complications Ligament sprain	0.00% 0/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	2.6% 1/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Injury, poisoning and procedural complications Post-traumatic neck syndrome	0.56% 1/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.56% 1/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Injury, poisoning and procedural complications Rib fracture	0.00% 0/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.56% 1/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Injury, poisoning and procedural complications Road traffic accident	0.56% 1/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.56% 1/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.56% 1/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Injury, poisoning and procedural complications Spinal column injury	0.00% 0/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	1.2% 1/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	1.2% 1/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Injury, poisoning and procedural complications Subdural haematoma	0.56% 1/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.56% 1/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Injury, poisoning and procedural complications Thoracic vertebral fracture	0.00% 0/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	1.2% 1/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Injury, poisoning and procedural complications Tibia fracture	0.00% 0/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.56% 1/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Investigations Blood creatine phosphokinase increased	0.56% 1/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	1.1% 2/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.56% 1/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Investigations Blood creatinine increased	0.00% 0/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	1.2% 1/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	1.2% 1/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Investigations Blood sodium decreased	0.00% 0/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	1.2% 1/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	1.2% 1/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Investigations Weight decreased	0.00% 0/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	1.2% 1/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.56% 1/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Metabolism and nutrition disorders Diabetes mellitus	1.7% 3/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	1.7% 3/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Metabolism and nutrition disorders Diabetic ketoacidosis	0.00% 0/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	1.2% 1/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	1.2% 1/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Metabolism and nutrition disorders Hyperglycaemia	0.56% 1/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	1.2% 1/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.56% 1/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	1.2% 1/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Metabolism and nutrition disorders Hyperlipidaemia	0.00% 0/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	1.2% 1/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	1.2% 1/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.56% 1/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	2.6% 1/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.00% 0/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	1.2% 1/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	1.2% 1/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Musculoskeletal and connective tissue disorders Arthralgia	0.56% 1/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.56% 1/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.56% 1/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	1.2% 1/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Musculoskeletal and connective tissue disorders Chondritis	0.00% 0/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	1.2% 1/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.56% 1/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.56% 1/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.56% 1/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.56% 1/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.56% 1/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.56% 1/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	1.1% 2/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Musculoskeletal and connective tissue disorders Pain in extremity	0.56% 1/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.56% 1/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Musculoskeletal and connective tissue disorders Pathological fracture	0.00% 0/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	1.2% 1/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Musculoskeletal and connective tissue disorders Tendonitis	0.56% 1/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.56% 1/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute myeloid leukaemia	0.56% 1/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.56% 1/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign breast neoplasm	0.00% 0/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.56% 1/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cervix carcinoma	0.00% 0/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	1.2% 1/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hypopharyngeal neoplasm	0.00% 0/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	1.2% 1/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	1.2% 1/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Invasive ductal breast carcinoma	0.56% 1/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.56% 1/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lipoma	0.00% 0/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.56% 1/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Mixed hepatocellular cholangiocarcinoma	0.56% 1/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.56% 1/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Papillary thyroid cancer	0.56% 1/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.56% 1/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pituitary tumour benign	0.00% 0/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.56% 1/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Plasma cell myeloma	0.00% 0/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	1.2% 1/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal oncocytoma	0.00% 0/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.56% 1/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Respiratory papilloma	0.00% 0/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	1.2% 1/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	1.2% 1/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Nervous system disorders Diabetic hyperglycaemic coma	0.56% 1/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.56% 1/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Nervous system disorders Dizziness	0.56% 1/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.56% 1/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Nervous system disorders Migraine	0.00% 0/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.56% 1/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Nervous system disorders Multiple sclerosis	0.56% 1/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.56% 1/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Nervous system disorders Seizure	0.00% 0/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.56% 1/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Pregnancy, puerperium and perinatal conditions Abortion spontaneous	0.00% 0/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	2.6% 1/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Psychiatric disorders Catatonia	0.56% 1/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.56% 1/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Psychiatric disorders Completed suicide	0.56% 1/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.56% 1/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Psychiatric disorders Major depression	0.56% 1/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.56% 1/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Renal and urinary disorders Acute kidney injury	0.00% 0/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.56% 1/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Renal and urinary disorders Hydronephrosis	0.00% 0/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.56% 1/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Renal and urinary disorders Nephrolithiasis	1.1% 2/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	1.1% 2/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Renal and urinary disorders Urinary incontinence	0.56% 1/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.56% 1/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Reproductive system and breast disorders Breast mass	0.56% 1/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.56% 1/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Reproductive system and breast disorders Uterine prolapse	0.56% 1/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.56% 1/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Respiratory, thoracic and mediastinal disorders Lung infiltration	0.00% 0/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.56% 1/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Respiratory, thoracic and mediastinal disorders Nasal polyps	0.00% 0/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	1.2% 1/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	1.2% 1/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Respiratory, thoracic and mediastinal disorders Pulmonary mass	0.00% 0/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.56% 1/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Skin and subcutaneous tissue disorders Chronic pigmented purpura	0.00% 0/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.56% 1/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Vascular disorders Aortic aneurysm rupture	0.00% 0/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	1.2% 1/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	1.2% 1/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Vascular disorders Arteriovenous fistula	0.00% 0/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.56% 1/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Vascular disorders Hypertension	0.00% 0/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.56% 1/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Vascular disorders Peripheral venous disease	0.00% 0/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	2.6% 1/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.

Other adverse events

Measure	Pasireotide LAR - up to 26 Months n=178 participants at risk Includes data from both blinded core and extension phase (up to Month 26 cutoff date of 29-Dec-2011) for patients who continued the same treatment (Pasireotide LAR) as in the core. For patients who switched from blinded Pasireotide LAR to Octreotide LAR treatment, only data collected before crossover is included.	Octreotide LAR - up to 26 Months n=180 participants at risk Includes data from both blinded core and extension phase (up to Month 26 cutoff date of 29-Dec-2011) for patients who continued the same treatment (Octreotide LAR) as in the core. For patients who switched from blinded Octreotide LAR to Pasireotide LAR treatment, only data collected before crossover is included.	Crossed Over to Pasireotide LAR - up to 26 Months n=81 participants at risk Includes all data in the extension phase (up to 26-Month cutoff date of 29-Dec-2011) collected after the crossover time point for patients who crossed over from Octreotide LAR in the core to Pasireotide LAR treatment in the extension phase.	Crossed Over to Octreotide LAR - up to 26 Months n=38 participants at risk Includes all data in the extension phase (up to 26-Month cutoff date of 29-Dec-2011) collected after the crossover time point for patients who crossed over from Pasireotide LAR in the core to Octreotide LAR treatment in the extension phase.	Pasireotide LAR - up to EOS n=178 participants at risk Includes data from both core and extension phase (up to End-of-study date of 11-Mar-2016) for patients who continued the same treatment (Pasireotide LAR) as in the core. For patients who switched from blinded Pasireotide LAR to Octreotide LAR treatment, only data collected before crossover is included. Per protocol, patients on Pasireotide LAR could continue to receive open-label Pasireotide LAR after treatment unblinding at Month 26, whereas those on Octreotide LAR were not followed after Month 26.	Crossed Over to Pasireotide LAR - up to EOS n=81 participants at risk Includes all data in the extension phase (up to End-of-study date of 11-Mar-2016) collected after the crossover time point for patients who crossed over from Octreotide LAR in the core to Pasireotide LAR treatment in the extension phase. Per protocol, patients on Pasireotide LAR could continue to receive open-label Pasireotide LAR after treatment unblinding at Month 26, whereas those on Octreotide LAR were not followed after Month 26.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	3.9% 7/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	1.7% 3/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	1.2% 1/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	2.6% 1/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	5.1% 9/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	2.5% 2/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Respiratory, thoracic and mediastinal disorders Cough	6.2% 11/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	9.4% 17/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	1.2% 1/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	2.6% 1/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	9.0% 16/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	3.7% 3/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	4.5% 8/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	8.3% 15/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	3.7% 3/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	2.6% 1/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	5.1% 9/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	4.9% 4/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Skin and subcutaneous tissue disorders Alopecia	19.1% 34/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	20.0% 36/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	3.7% 3/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	2.6% 1/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	19.1% 34/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	4.9% 4/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Vascular disorders Hypertension	10.1% 18/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	8.9% 16/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	6.2% 5/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	7.9% 3/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	11.8% 21/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	7.4% 6/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Musculoskeletal and connective tissue disorders Osteoarthritis	2.2% 4/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	2.2% 4/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	1.2% 1/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	5.3% 2/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	2.2% 4/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	2.5% 2/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Musculoskeletal and connective tissue disorders Pain in extremity	7.9% 14/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	4.4% 8/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	7.4% 6/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	2.6% 1/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	9.0% 16/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	7.4% 6/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Nervous system disorders Dizziness	11.8% 21/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	11.1% 20/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	8.6% 7/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	10.5% 4/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	12.4% 22/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	11.1% 9/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Nervous system disorders Headache	23.0% 41/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	27.2% 49/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	21.0% 17/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	13.2% 5/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	23.6% 42/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	24.7% 20/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Nervous system disorders Paraesthesia	4.5% 8/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	2.2% 4/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	2.6% 1/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	5.1% 9/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Psychiatric disorders Anxiety	5.1% 9/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	3.9% 7/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	1.2% 1/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	6.2% 11/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	2.5% 2/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Psychiatric disorders Insomnia	4.5% 8/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	5.0% 9/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	2.5% 2/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	2.6% 1/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	6.7% 12/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	4.9% 4/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Renal and urinary disorders Haematuria	3.4% 6/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	1.1% 2/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	1.2% 1/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	5.3% 2/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	4.5% 8/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	2.5% 2/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Renal and urinary disorders Pyelocaliectasis	0.00% 0/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	5.3% 2/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Blood and lymphatic system disorders Anaemia	7.9% 14/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	5.6% 10/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	7.4% 6/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	2.6% 1/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	10.7% 19/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	9.9% 8/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Cardiac disorders Sinus bradycardia	7.3% 13/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	5.6% 10/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	2.5% 2/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	2.6% 1/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	8.4% 15/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	3.7% 3/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Eye disorders Cataract	0.00% 0/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.56% 1/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	1.2% 1/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	5.3% 2/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	1.2% 1/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Gastrointestinal disorders Abdominal discomfort	4.5% 8/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.56% 1/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	5.6% 10/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Gastrointestinal disorders Abdominal distension	11.8% 21/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	12.2% 22/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	5.3% 2/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	11.8% 21/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Gastrointestinal disorders Abdominal pain	18.5% 33/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	23.9% 43/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	3.7% 3/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	2.6% 1/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	20.2% 36/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	4.9% 4/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Gastrointestinal disorders Abdominal pain upper	6.7% 12/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	9.4% 17/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	3.7% 3/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	7.9% 14/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	4.9% 4/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Gastrointestinal disorders Constipation	5.6% 10/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	10.6% 19/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	4.9% 4/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	2.6% 1/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	7.3% 13/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	6.2% 5/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Gastrointestinal disorders Diarrhoea	39.3% 70/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	43.9% 79/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	24.7% 20/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	15.8% 6/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	40.4% 72/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	32.1% 26/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Gastrointestinal disorders Dyspepsia	4.5% 8/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	3.9% 7/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	3.7% 3/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	2.6% 1/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	5.1% 9/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	4.9% 4/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Gastrointestinal disorders Flatulence	5.6% 10/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	6.1% 11/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	6.2% 11/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Gastrointestinal disorders Gastrooesophageal reflux disease	1.1% 2/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	1.1% 2/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	2.5% 2/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	5.3% 2/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	1.1% 2/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	2.5% 2/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Gastrointestinal disorders Large intestine polyp	0.56% 1/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	2.5% 2/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	5.3% 2/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.56% 1/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	2.5% 2/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Gastrointestinal disorders Nausea	15.2% 27/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	22.8% 41/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	9.9% 8/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	5.3% 2/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	16.3% 29/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	12.3% 10/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Gastrointestinal disorders Vomiting	10.7% 19/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	8.3% 15/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	3.7% 3/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	2.6% 1/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	12.4% 22/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	4.9% 4/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
General disorders Fatigue	11.2% 20/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	11.7% 21/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	7.4% 6/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	7.9% 3/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	11.8% 21/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	8.6% 7/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
General disorders Injection site pain	7.3% 13/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	5.0% 9/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	2.6% 1/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	7.9% 14/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
General disorders Pyrexia	4.5% 8/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	5.6% 10/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	1.2% 1/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	6.2% 11/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	2.5% 2/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Hepatobiliary disorders Biliary dilatation	2.8% 5/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	4.4% 8/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	4.9% 4/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	2.6% 1/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	2.8% 5/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	6.2% 5/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Hepatobiliary disorders Cholelithiasis	31.5% 56/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	38.3% 69/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	22.2% 18/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	15.8% 6/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	33.1% 59/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	28.4% 23/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Hepatobiliary disorders Gallbladder polyp	2.8% 5/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	1.7% 3/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	4.9% 4/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	5.3% 2/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	4.5% 8/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	6.2% 5/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Hepatobiliary disorders Hepatic steatosis	5.6% 10/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	6.1% 11/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	7.4% 6/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	7.9% 3/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	6.2% 11/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	7.4% 6/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Infections and infestations Bronchitis	5.6% 10/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	2.2% 4/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	7.3% 13/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	2.5% 2/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Infections and infestations Influenza	9.0% 16/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	6.1% 11/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	3.7% 3/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	7.9% 3/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	10.1% 18/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	4.9% 4/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Infections and infestations Nasopharyngitis	18.0% 32/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	16.1% 29/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	16.0% 13/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	18.4% 7/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	19.1% 34/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	18.5% 15/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Infections and infestations Sinusitis	3.4% 6/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	3.3% 6/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	2.5% 2/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	2.6% 1/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	5.1% 9/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	3.7% 3/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Infections and infestations Upper respiratory tract infection	9.0% 16/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	3.9% 7/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	3.7% 3/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	5.3% 2/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	11.2% 20/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	6.2% 5/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Infections and infestations Urinary tract infection	5.1% 9/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	6.7% 12/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	6.2% 5/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	6.2% 11/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	12.3% 10/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Investigations Alanine aminotransferase increased	8.4% 15/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	5.6% 10/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	3.7% 3/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	9.0% 16/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	6.2% 5/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Investigations Aspartate aminotransferase increased	6.7% 12/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	4.4% 8/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	3.7% 3/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	7.3% 13/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	6.2% 5/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Investigations Blood bilirubin increased	5.1% 9/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	2.8% 5/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	1.2% 1/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	2.6% 1/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	6.2% 11/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	3.7% 3/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Investigations Blood creatine phosphokinase increased	14.0% 25/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	13.3% 24/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	8.6% 7/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	15.8% 6/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	15.2% 27/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	9.9% 8/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Investigations Blood glucose increased	9.6% 17/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	3.3% 6/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	9.9% 8/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	10.1% 18/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	9.9% 8/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Investigations Blood thyroid stimulating hormone decreased	2.2% 4/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	1.1% 2/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	1.2% 1/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	5.3% 2/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	2.8% 5/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	1.2% 1/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Investigations Blood triglycerides increased	2.2% 4/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	2.2% 4/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	2.5% 2/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	10.5% 4/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	4.5% 8/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	2.5% 2/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Investigations Blood uric acid increased	3.4% 6/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	1.7% 3/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	1.2% 1/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	5.6% 10/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	2.5% 2/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Investigations Electrocardiogram QT prolonged	5.1% 9/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	5.6% 10/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	3.7% 3/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	5.6% 10/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	4.9% 4/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Investigations Gamma-glutamyltransferase increased	1.7% 3/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	6.1% 11/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	1.2% 1/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	1.7% 3/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	2.5% 2/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Investigations Glycosylated haemoglobin increased	6.2% 11/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	2.8% 5/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	8.6% 7/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	6.7% 12/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	11.1% 9/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Investigations Insulin-like growth factor decreased	0.56% 1/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	1.2% 1/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	1.1% 2/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	6.2% 5/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Investigations Lipase increased	5.6% 10/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	7.2% 13/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	3.7% 3/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	5.3% 2/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	6.2% 11/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	3.7% 3/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Investigations Weight decreased	5.1% 9/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	4.4% 8/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	2.5% 2/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	5.1% 9/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	6.2% 5/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Metabolism and nutrition disorders Diabetes mellitus	21.3% 38/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	4.4% 8/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	22.2% 18/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	7.9% 3/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	22.5% 40/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	23.5% 19/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Metabolism and nutrition disorders Glucose tolerance impaired	1.7% 3/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.56% 1/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	6.2% 5/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	1.7% 3/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	6.2% 5/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Metabolism and nutrition disorders Hypercholesterolaemia	3.9% 7/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	2.2% 4/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	2.5% 2/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	2.6% 1/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	5.6% 10/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	2.5% 2/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Metabolism and nutrition disorders Hyperglycaemia	30.9% 55/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	10.0% 18/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	30.9% 25/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	13.2% 5/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	31.5% 56/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	35.8% 29/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Metabolism and nutrition disorders Hyperlipidaemia	2.8% 5/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	2.2% 4/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	6.2% 5/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	5.3% 2/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	2.8% 5/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	6.2% 5/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Metabolism and nutrition disorders Hyperuricaemia	2.8% 5/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	1.1% 2/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	1.2% 1/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	5.1% 9/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	2.5% 2/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Metabolism and nutrition disorders Hypoglycaemia	6.2% 11/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	7.8% 14/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	8.6% 7/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	5.3% 2/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	7.9% 14/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	9.9% 8/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Metabolism and nutrition disorders Type 2 diabetes mellitus	6.7% 12/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	3.7% 3/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	0.00% 0/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	6.7% 12/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	4.9% 4/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Musculoskeletal and connective tissue disorders Arthralgia	11.8% 21/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	13.9% 25/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	12.3% 10/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	5.3% 2/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	13.5% 24/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	17.3% 14/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Musculoskeletal and connective tissue disorders Back pain	12.4% 22/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	11.7% 21/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	7.4% 6/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	7.9% 3/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	13.5% 24/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	9.9% 8/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.
Musculoskeletal and connective tissue disorders Muscle spasms	4.5% 8/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	5.6% 10/180 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	8.6% 7/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	2.6% 1/38 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	5.6% 10/178 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.	9.9% 8/81 Safety Set (SS): all pts given drug with post baseline assessment. Pts analyzed as per treatment (trt) 1st received. 2 pts randomized to Oct. LAR who received Pas. LAR as 1st dose were included in Pas. grp. Crossover Analysis Set (CAS): all pts with 1st dose in Ext. different from 1st dose in Core. Pts were analyzed acc. to crossover trt received.

Additional Information

Study Director

Novartis Pharmaceuticals

Phone: 862-778-8300

Results disclosure agreements

• Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of pooled data (i.e.,data from all sites) in clinical trial or disclosure of trial results in their entirety.
• Publication restrictions are in place

Restriction type: OTHER